The Fuji Computed Radiography. (FCR) system with FCRMS installed (FCRm)
and a display device replaces the screen- film receptor and chemical processing
...
Fuji Computed Radiography Mammography Suite (FCRMS) ESSENTIAL PRESCRIBING INFORMATION PRESCRIPTION DEVICE Caution: Federal law restricts this device to sale by or on the order of a physician. DEVICE DESCRIPTION machine In conventional screen-film mammography (SFM), a mammographic x-ray receptor exposes the breast and projects an aerial x-ray intensity image onto a screen-film Radiography which is then processed to produce an analog image. The Fuji Computed the screenreplaces device (FCR) system with FCRMS installed (FCRm) and a display film receptor and chemical processing system to produce a digital image. devices FCRm should be used with mammographic x-ray machines and output display for primary that are cleared by the United States Food and Drug Administration (FDA) are: image interpretation in mammography. The requirements for these components Mammographic X-ray Machine in the United An x-ray machine specifically designed for mammography and legally sold States for mammography should be used. filter The x-ray tube should have as a minimum a molybdenum target and molybdenum any of (Mo/Mo) combination for calibration of the FCRm image reader and optionally rhodium with the following anode target and filter combinations: molybdenum target target with filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten rhodium filter (W/Rh). exposure The x-ray system should have both manual exposure control and automatic and kVp, or mAs or only, mAs control (AEC). The AEC may be of the type controlling mAs, kVp and filter, or mAs, kVp, filter, and target. Fuji Computed Radiography System FCRm consists of the following: * Fuji dual-side Imaging Plates HR-BD in 18cm x 24 cm or 24cm x 30 cm sizes, for capturing the x-ray images and a corresponding number of Fuji IP Cassettes DM in the same sizes, for transporting the imaging plates; * a Fuji ClearView image reader configured for dual-side reading and 50 plate in micrometer sampling pitch; for reading the x-ray image from the imaging the cassette; and * a Fuji Flash Plus TIP CR console unit, the "acquisition" workstation with FCRMS installed.
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information console unit may be With FCRMS installed in the Flash Plus lip CR console unit, the referred to as a Fuji Flash Plus I1Pm (appending an italic m for mammography). m appended to the Similarly, a connected image reader may be labeled with an italic reader. A complete model name, e.g., a Fuji ClearView CSm or ClearView Im image ClearView m FCRm system for mammography (HR-BD imaging plates, DM cassettes, Flash Plus I1Pm reader (for example ClearView CSm, ClearView I m, or other), and console) is also known as an FCRm system. Softcopy or Hardcopy Display on a: Primary interpretation of softcopy images must be performed either cleared * review work station consisting of a PC-based computer with FDA presentation" "for mammography displays capable of handling DICOM MG images; or of * Fuji review workstation with FDA cleared mammography displays capable handling DICOM MG "for presentation" or "for processing" images. with a minimum The review workstation should have a minimum of two displays, each image array size of five megapixels. for mammography For primary interpretation of hardcopy images, use a printer cleared a pixel pitch of 50 with that supports DICOM basic grayscale print management service 3.6. micrometers or less and film maximum optical density of at least INDICATIONS FOR USE is a software device The Fuji Computed Radiography Mammography Suite (FCRMS) system forms the Fuji that, in conjunction with a specified Fuji Computed Radiography with a dedicated Computed Radiography for mammography (FCRm) device. FCRm that can be used mammographic x-ray machine generates digital mammographic images in the same clinical for screening and diagnosis of breast cancer. It is intended for use systems. The applications as traditional screen-film based mammographic (SFM) either hardcopy using mammographic images can be interpreted by a qualified physician film or softcopy display at a workstation. CONTRAINDICATIONS There are no known contraindications. WARNINGS AND PRECAUTIONS Cautions and Warnings
in theFCRm
UserGuide:
Warnings: * For U.S. only: Until an accreditation body has been approved to accredit the of an FCRm unit, FDA will continue its process for extending the certificationnotified otherwise Until already certified facility to include these specific units. Page 2 of 22
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information by FDA, a facility with an FCRm unit (that does not have a corresponding approved accreditation body) will be exempt from the MQSA accreditation to cover its requirement but must request FDA to extend its current certification unaccredited FCRm unit. be * The mammographic x-ray system's automatic exposure control (AEC) should calibrated for use with FCRm prior to use. that is • The FCRm image reader must be calibrated with S value in mammography a based on an exposure to the imaging plate of 20 mR at 25 kVpusing only air in the molybdenum (Mo) target and Mo filter (Mo/Mo 0.03 mm) with beam. * The x-ray system must have a molybdenum (Mo) target and Mo filter for S value calibration. mechanical * Insertion of a broken cassette into an FCRm reader can result in failure and system shutdown. Cautions: with x-ray *FCRm does not emit radiation; however, it is used in conjunction with the emitting equipment. Refer to the Cautions and Warnings associated x-ray emitting equipment. · Do not use the Fuji reader and console in the presence of a flammable anesthetic or gaseous mixtures. * The user should follow the x-ray exposure unit instructions in order to safely operate the exposure device. * Do not use the Flash Plus liP Computer Radiography (CR) console for primary interpretation of patient images. The site is *Only authorized, trained personnel should operate this equipment. are responsible for ensuring that proper operating techniques and procedures followed when operating the FCRm. to * The softcopy review station should be located in a suitably dark environment measured at the enhance image visibility during review. The ambient light level, not exceed 20 surface of the monitor screen (with the monitor turned off), should lux. * DO NOT remove any covers or attempt to service the system. The system contains no user serviceable parts. media. * Do not touch t-e recording surface of magnetic or optical storage review station * Do not add unauthorized software to the CR console or soft copy or cause computers. Unauthorized software may affect system performance conflicts with system operation.
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information necessary, remove the DO NOT insert a moist cassette into the CR reader. If the imaging plate is dry) imaging plate from wet cassette and insert it (make sure into a dry cassette. for mammography. * Only use the HR-BD Imaging Plate and Fuji IP Cassette DM the imaging plates. * Do not use water, screen cleaner, or isopropyl alcohol to clean cleaning of an imaging Anhydrous ethanol is the only solution suitable for wet plate. of * A protective, plastic bag should be used to cover the cassette in the presence blood or other body fluids. * Always follow the facilities' infection control guidelines. or any * Always wear appropriate protective clothing when handling blood cleaning solutions. should be cleaned and Equipment contaminated with blood or other body fluids disinfected with the appropriate agents. ensure that imaging plates * In a fixed site or mobile environment, after exposure, quality. are read without undo delay to preserve optimal image Cautions
and Warninms in the FCRm Quality Control Manual:
Cautions: for mammographic * Use only the Fuji IP Cassette DM and Fuji IP HR-BD imaging and QC testing. and QC tests, * Perform the Sensitivity Conformation test prior to the Acceptance filter at 25kVp. Do not using only molybdenum (Mo) target and Mo 0.03 mm cause an error in use any additional filter as the use of another filter may sensitivity confirmation. the lowest MR * If the mammography x-ray unit will not allow 20 mR exposures, 25 kVp for the sensitivity exposure greater than 20 should be used. Always use confirmation test.
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information POTENTIAL ADVERSE EFFECTS FCRm: The following potential adverse effects that apply to mammography using * excessive breast compression; * excessive x-ray exposure; * electrical shock; * infection and skin irritation; or * abrasion or puncture wound SUMMARY OF NON-CLINICAL STUDIES Sensitometric Response by exposing The sensitometric response of the Fuji HR-BD imaging plate was assessed imaging with representative plates to x-ray beams with spectra typical of mammographic processing was a polymethylmethacrylate (PMMA) phantom in the beam. No image were images the of performed. The pixel values obtained from the central region in this case for recorded (see Figure 1). QL is the variable name used for the pixel value, an unprocessed image.
,-,2,500
21000 ~1,5000--
04 QL( 11 bit) with 40mam PMMA QL(1 lIbit) with 70mm PMMA ....!
_
_
~1,500
,000 ux500
C/ 0 1.OOE-01
1.00E+00
----1.00E+01
----1.00E+02
1.00E+03
ex pnslre(mR) Figure 1. Sensitometric Response of Imaging Plate
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information Spatial Resolution of FCRMS The spatial resolution of the HR-BD imaging plate with the image processing x-ray was measured by imaging contrast transfer function phantoms with mammographic Transfer Contrast the from spectra. The Modulation Transfer (MTF) was calculated along with MTF Function (CTF) data. The results for processed and unprocessed images for a SFM system are shown in Figure 2.
MTF FCRMS (with HR-BD and ClearView CS) and Screen-Film System 1.600 -S---
ClearView CS
Main-scan Direction
1.400
1.200
(unprocessed) - - - .-ClearView CS Sub-scan Direction (unprocessed) ClearView CS -+--Main-scan Direction (processed) 41·- ClearView CS Sub-scan Direction (processed) 0 Screen-Film
-
1.000 0.800 0.600 0.400 0.200 0.000 0
[t 8 6 4 2 Spatial Frequency (cyc/mm)
10
Figure 2. MTF Measurements With and Without Image Processing Signal to Noise Transfer and Dynamic Range and Quantitative measure of the efficiency of signal to noise ratio (SNR) transfer equivalent noise the dynamic range of the image acquisition system were measured by of spatial quanta (NEQ) and the detective quantum efficiency (DQE) as a function of the HRfrequency and radiation exposure level. These qualities of the combination spatial resolution BD imaging plate and FCRMS were measured by combining noise and as NEQ expressed are and measurements made at several different radiation expustrcs and DQE as a function of spatial frequency as shown in Figures 3 and 4.
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5z/f
Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information NEQ
I 4DE 0 I 20E.6+O
I00E+06
._ __ _ __ _ __ _
-
.
.,
-
~U
--
4tn
36~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~1 mR-
S
Im -
a6 00E 05
-*
400E+056 +2.0 0 5 0 ---
-y
…
~
IS
0
. .- . . .
--
- - --
35 ~3 ~ ~~~2
25 ~ ~~~
4
Spatialfreuecy(ycedm
Figure 3. Relationship between NEQ and X-ray Exposure are shown below The relationship between DQE, x-ray exposure, and spatial frequency in Figure 4. DQE
0400 0,350
0300
aV
0 250
-
--
--
-
-
-
-
--
- --
2--G3----
0 150
8m
--- 20mR
-
0 200 0 100
-
4-o----9.8mR
*~-y-_ -
-
3 6mR
8-. SmR
-
00524
Figure 4. Relationship Between DQE and X-ray Exposure Phantom Tests was tested with two The imaging performnance of FCRMS with the HR-BD imaging plate phantom types of phantoms. One was a contrast-detail mammography (CDMAM) array of circular manufactured by Nuclear Associates. This phantom contains a square the direction of one test objects which are constant in diameter and vary in contrast in Page 7 of 22
Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information orthogonal side of the square and are constant in contrast and vary in diameter in the gold thickness) of direction. An x-ray image of the phantom is made and the contrast (or is noted. Images the lowest contrast visible test object at each value of object diameter plate. The were obtained with a Fuji IP Cassettes DM cassette and a HR-BD imaging Pattern images from the imaging plate were processed both with and without the results are Enhancement for Mammography (PEM) image processing software. The of the disk displayed in Table I and Figures 5 and 6. The k-values are the product 60 -80 gim 2. diameter and the thickness. Ideal k-values that a system should detect are of each of the The image quality factor (IQF) is the sum of the products of the diameters of IQF, the better smallest scored objects and their relative contrast. The lower the value is the image quality. Disk Thickness (urn) Screen-Film FCRm Fuji UMFine Mammo with UM-MA HC
Disk (mm) 0.1
1
1
I 0.13 0.16
0.8
0.8
0.63
0.5
0.4
0.4
0.31
0.25
0.63
1
013
0.8
0.20
40.16
0.16
1.25
0.08
0.13
1.6
0.63
0.06
0.8 ~~ 0.13 1 ~~~0.1
0.08 0.08
2
0.06
0.06
2.5
0.06
0.06
3.2
0.06
0.06
IQF
1.60
1.46
.
1
'Fable 1. IQF Results with SFM and FCRm
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information
Contrast detail curve
1.. - ---
SFM
-*-FCRm
~0.1
0.01 0.1
1
10
Disk Diameter (mm) Figure 5. Contrast Detail Curve for SFM and FCRm
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information
10
4S SFM a FCRm
-- Ideal pattern K = 80 - Ideal pattern K = 60
Vm 2 pm 2
0.2
0.1
0.3
Disk Thickness, pm Figure 6. Contrast Detail Curve for SFM and FCRm with Ideal k Values College of Radiology In another phantom image experiment, an FDA approved American for image quality (ACR) Mammography Accreditation Phantom (RMI-156) was used to acquire the evaluation. Both HR-BD imaging plates and a SFM cassette were used images and score them. The scores are shown in Table 2. Table 2. ACR Phantom Results
Fiers
SFM 4.7
Specks
3.5
ScoreFCRm Score 5.0 3.8
Mases3.36
SUMMARY OF CLINICAL STUDIES Mammography Study 1 Comparative Accuracy of FCRm Compared to Screen-Film (SFM) in Detection of Breast Cancer Study Objective from diagnostic To test the non-inferiority of FCRm compared to SFM among patients and screening populations. Page 10 of 22
Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information Primary Objective in detection of breast cancer To compare the accuracy of FCRm and SFM mammography using hard copy film. among women undergoing screening or diagnostic mammography Secondary Objectives SFM. To compare the sensitivity and specificity of FCRm and Design in the United States in which A prospective, multi-center, cohort study was conducted site. Two sites participated as patients underwent both FCRm and SFM at the acquisition reading center (CRC). image acquisition sites and one site participated as the core whose mammograms populations Patients were enrolled from screening and diagnostic Breast Imaging Reporting were interpreted as American College of Radiology (ACR®) 1,2, or 3. In addition, the study and Database System (BI-RADS®) assessment category category 4 or 5. was enriched by enrolling patients with BI-RADS® assessment four standard views: right FCRm and original SFM hard copy examinations of the (LMLO), right craniocaudal mediolateral oblique (RMLO), left mediolateral oblique CRC for independent (RCC), and left craniocaudal (LCC) were provided to the CRC readers completed interpretation by six MQSA-qualified radiologist readers. examination. Readers standardized image interpretation forms for each mammography category and were asked to reported the anticipated final ACR® BI-RADS® assessment continuous scale ranging from 0 record their assessment of the probability of cancer on a (no chance of cancer) to 100 (certainty of cancer). Patient Population all of the following criteria: Women were eligible for the study provided they fulfilled diagnostic SFM * underwent or were scheduled to undergo a screening or examinationa at one of the acquisition sites; * at least 40 years of age; in this * provided written informed consent indicating willingness to participate and research study prior to performance of the FCR® mammogram; * met none of the exclusion criteria. of the following: Women were not eligible for enrollment if they had any * abreast implant; and "study" have been a For a single patient, the terms "examination", "mammogram", or without special views. The used interchangeably to mean four standard views with (LCC), right four standard views are right craniocaudal (RCC), left craniocaudal (LMLO). mediolateral oblique (RMLO), and left mediolateral oblique
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information * a unilateral mammogram or an incomplete SF mammogram; * excisional breast biopsy with a finding of carcinoma; * pregnancy or possibility of pregnancy; * self-reported, non-focal or bilateral breast pain; * penal incarceration; or * inability to undergo follow-up mammography examinations. Variables characteristic (ROC) area, The primary analysis variables included the receiver operating sensitivity, and specificity. * The primary endpoint was the area under the ROC curve (AUC). AUC was based that a breast had on the CRC readers' subjective assessments of the probability to 100 cancer using a continuous scale ranging from 0 (no chance of cancer) (certainty of cancer). * Sensitivity and specificity were secondary endpoints. Sensitivity and specificity were based on the CRC readers' BI-RADSTM category assessments. Processes at the acquisition Each SFM and FCRm examination was interpreted by the radiologist and conspicuity, site who reported finding location, finding characterization, finding brief medical history and diagnostic work-up. In addition, the acquisition sites reported image acquisition parameters. by six readers at Each SFM and FCRm examination was also interpreted independently or presence of cancer the CRC. CRC readers' subjective impression about the absence of cancer) to 100 was reported, by quadrant, on a continuous scale from 0 (no chanceBI-RADSTM category (certainty of cancer). Additionally, the CRC readers reported the by quadrant. The primary analysis was based on CRC data. Statistical Methods to FCRm were The analysis of AUC, sensitivity, and specificity of SFM compared as the unit quadrant, the performed using the individual breast, rather than the patient or of analysis. CRC readers using the The AUC for SFM and FCRm were estimated for each of the six breast. A nonparametric readers' highest assessment of the probability of cancer in each of the that takes into account the clustered nature method [Obuchowski, 199711 was usedThe difference the for limit confidence 95% upper data (that is, two breasts per patient). was constructed using the random-effects FCRm to compared in the AUC areas of SFM model of Dorfman, Berbaum, and Metz [Dorfman, 19922]. Page 12 of 22
Is,
Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information estimated for each CRC reader The sensitivity and specificity of SFM and FCRm were 1, BI-RADS® categories I and based on the BI-RADS® category. In calculation method 5 were considered positive. In 2 were considered negative and categories 0, 3, 4, and 3 were considered negative, and calculation method 2, BI-RADS® categories 0, 1,2 and breast, the BI-RADS® category for categories 4 and 5 were considered positive. For each used for the analysis of sensitivity the quadrant with the highest probability of cancer was Equations (GEE), as described by and specificity. The method of Generalized Estimating used to estimate the difference Diggle, Heagerty, Liang, and Zeger [Diggle, 20023], was while taking into account the in sensitivity and specificity between SFM and FCRm correlation between breasts in a single patient. was evaluated by the acquisition The difference in conspicuity between SFM and FCRm detectable finding per site radiologist based on the most suspicious mammographically finding most conspicuous patient. This included the main feature that makes the architectural distortion, or (specifically, calcification, mass only, mass with calcifications, the most conspicuous feature; the focal asymmetry); the breast, quadrant, and view with finding identifiable and 11 =highly conspicuity scale (ranging from 0 to 11, where 0 = no between SFM and FCRm was due conspicuous); and whether a difference in conspicuity not detectable on SF, but were to a difference in patient positioning. Findings that were scale value of zero for detectable on FCRm (or vice versa), were assigned a conspicuity not detectable. The difference in the modality (SFM or FCRm on which the finding was the Wilcoxon signed rank test. conspicuity between SFM and FCRm was tested using Test of Equivalent Effectiveness effectiveness if: (a) the upper 95% SFM and FCRm were determined to have equivalent for SFM versus FCRm was less than confidence limit on the observed difference in AUC on the observed differences in or equal to 0.10; or (b) the upper 95% confidence limits less than or equal to 0.10. sensitivity and specificity for SFM versus FCRm are Case Selection Bias Adjustment magnitude of the case selection An analytical approach was developed to estimate the based on the results of their SFM bias, which resulted from enrolling patients in the study in light of this case selection bias, examinations at the acquisition sites. The expectation, in the study. The AUC, was that the sensitivity of FCRm would be less than SFM using this approach to estimate the sensitivity, and specificity analyses were implemented magnitude of the case selection bias. Study
Results
Patient Disposition and Demography (161 at the Mayo Clinic and 57 A total of 218 patients were enrolled in the investigation Five patients were excluded from at the University of California - Los Angeles (UCLA).
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information classified as not evaluable. the analyses, 3 protocol deviations at enrollment and 2 patients Of the remaining 213 patients: * mean age was 57.9 years * 86.4
0/
(n=18 4 ) were Caucasian;
* 37% (n =79) had dense breast tissue composition; (ntz98) were from a * 54% (n~l 15) were from a screening population and 46% diagnostic population; as follows: 10% category * distribution of final ACR® BL-RADS® assessments was category 5; 1, 14% category 2, 9% category 3, 53% category 4, and 14% cancer: * 28% (n~59) were determined by tissue sampling to have o 42% (n=25) of the cancers were from a screening population; o 58% (n-34) of the cancers were from a diagnostic population;
o
category 4; 54% (n=32) of cancers had a final assessment of BI-RADS® category 5; 46% (n=27) of cancers had a final assessment of BI-RADSO® and 63% (n=37) of cancer patients were enrolled at Mayo Clinic;
o
37% (n=22) of cancer patients were enrolled at UCLA.
o o
Mammography Findings among the 213 patients. * There were 176 marmmographically detectable findings were characterized * The most suspicious mammographically detectable findingSb 8% mass with as follows: 44% mass without calcifications; 37% calcifications; distortion. calcifications; 8% focal asymmetry; and 5% architectural (UICC) tumor, node, and * The percentage of International Union Against Cancer was 54% (desirable metastasis (TNM) classification Stage 0 or I tumors found percentage of minimal goal for a screening program > 50% [Bassett, 1994 4]).~ The as ductal carcinoma cancers found was 4 1%, where minimal cancers are defined to 1.0 cm (TNM in situ (TNM Stage 0) or invasive cancers less than or equal [Bassett, 1994]). 30% Stage IA or IB3) (desirable goal for a screening program > ROC Analysisand 0.8025 for FCRm with The overall areas under the ROC curves were 0.8622 for SFM interval of the difference was a difference of 0.0597 (see Figure 7). The 95% confidence each patient is defined as most suspicious marnmographically detectable finding for or more findings are equally the finding with the highest probability of cancer. If two most conspicuous finding (that suspicious (that is, equal probabilities of caijcer), then the exceeds 10000 because is, prominent finding) is reported. The total across findings calcifications. several patients had, for example, architectural distortion xvith b The
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Fuji Computed Radiography Mammography Suite (FCRMS) Essential Prescribing Information area under the ROC curve 0.0351 to 0.0843. In other words, with 95% confidence, the Because the upper 95% for SFM could be as much as 0.0843 greater than for FCRm the ROC curve for SFM confidence limit on the observed difference in the area under can be rejected (p
