Agfa's CR Mammography System with DX-M Digitizer is indicated for use in diagnostic and screening mammography. It is intended to be used wherever conventional film/ mammography screen systems are used.

Device Description

The new device is defined as:

. Agfa's DX-M digitizer.
HM5.0 image detectors designed for mammography, and .
. The NX user workstation with a mammography license.
The device uses detectors which are exposed to x-rays. The detectors are then scanned by the digitizer to create an electronic images are sent to a user workstation for patient identification, image previewing and adjustment, before sending them to a viewing workstation (PACS system) or printer for use by the physician. Principles of operation and technological characteristics of the new and predicate devices are the same. With optional general radiography screens and cassettes, the DX-M digitizer has the same capabilities as Agfa's DX-G.

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Conformity to electronic medical product safety, radiology, and medical imaging standards	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 6220-1-2, IEC 61223-2-3 and ACR/NEMA PS3.1-3.18 (DICOM). Conforms to ISO 13485, ISO 14971.
Sensitometric response	Test results demonstrated performance equivalent or better than the predicate device.
Spatial resolution	Test results demonstrated performance equivalent or better than the predicate device. DQE data presented in Figure 1 shows performance.
Noise analysis	Test results demonstrated performance equivalent or better than the predicate device.
Dynamic range	Test results demonstrated performance equivalent or better than the predicate device.
Erasure	Test results demonstrated performance equivalent or better than the predicate device.
Fading	Test results demonstrated performance equivalent or better than the predicate device.
Repeat exposures	Test results demonstrated performance equivalent or better than the predicate device.
AEC performance	Test results demonstrated performance equivalent or better than the predicate device.
Evaluation of images from mammography phantoms	Test results demonstrated performance equivalent or better than the predicate device.
Clinical image quality (breast positioning, exposure, image contrast, sharpness, tissue visibility at the skin line noise, and overall clinical image quality)	"Reviewers found all studies to be of acceptable overall clinical image quality."

Sample Size and Data Provenance for Test Set: The document does not specify a numerical sample size for the clinical image evaluation test set. It mentions "Anonymized images were evaluated." The data provenance (country of origin, retrospective/prospective) is not explicitly stated.
Number of Experts and Qualifications for Ground Truth (Test Set): The document states "An evaluation of clinical images by expert, MQSA qualified radiologists was conducted." The exact number of radiologists is not specified, nor is their specific years of experience. "MQSA qualified" indicates they meet the minimum qualification standards for interpreting mammograms in the United States.
Adjudication Method for Test Set: The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It only states that "reviewers found all studies to be of acceptable overall clinical image quality." This implies a consensus or individual assessment without a detailed adjudication process mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on assessing the image quality of the new device by expert radiologists, not on comparing human readers' performance with and without AI assistance.
Standalone Performance Study: Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted for the device's technical specifications. This is indicated by the "Laboratory imaging tests of the new device consistent with IEC 62220-1-2 has been completed" which included evaluation of sensitometric response, spatial resolution, noise analysis, dynamic range, erasure, fading, repeat exposures, AEC performance, and mammography phantoms.
Type of Ground Truth Used:
- For the technical laboratory tests (sensitometric response, spatial resolution, etc.), the ground truth was based on objective measurements and industry standards (IEC 62220-1-2) using phantoms.
- For the clinical image evaluation, the ground truth was based on expert consensus from MQSA qualified radiologists regarding "acceptable overall clinical image quality."
Sample Size for Training Set: The document does not mention a training set or its sample size. This submission is for a medical imaging digitizer, which typically doesn't involve machine learning training in the same way an AI algorithm would. Its performance is based on the physical characteristics of the imaging components and processing algorithms.
How Ground Truth for Training Set was Established: Not applicable, as a training set for machine learning is not described.

Summary

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K11324

DEC 2 2 2011

510(K) SUMMARY: AGFA DX-M

Common/Classification Name: 21CFR 892.1715 and 21CFR892.1650 Proprietary Name: CR Mammography System with DX-M Digitizer Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: May 6, 2011 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(K) for Agfa's CR Mammography System with DX-M Digitizer, a detector-only FFDM system. It is substantially equivalent to Fujifilm Medical Systems' Fuji Computed Radiography Mammography Suite (FCRm).

DEVICE DESCRIPTION B.

The new device is defined as:

. Agfa's DX-M digitizer.
HM5.0 image detectors designed for mammography, and .
. The NX user workstation with a mammography license.

The device uses detectors which are exposed to x-rays. The detectors are then scanned by the digitizer to create an electronic images are sent to a user workstation for patient identification, image previewing and adjustment, before sending them to a viewing workstation (PACS system) or printer for use by the physician. Principles of operation and technological characteristics of the new and predicate devices are the same. With optional general radiography screens and cassettes, the DX-M digitizer has the same capabilities as Agfa's DX-G.

C. INTENDED USE

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's CR Mammography System with DX-M Digitizer has an Indications For Use statement nearly . identical to the statement for the predicate device (Fuji FCRm). Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

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PRODUCT COMPARISON TABLE
	NEW DEVICEAgfa CR Mammography Systemwith DX-M Digitizer	Predicate - PA05014Fuji Computed Radiography forMammography, FCRm
Indications	Same as the predicate	Mammography
Communications	Same as the predicate	DICOM
Detector Material	CsBr:Eu2+	BaFBr₁₋ₓIₓ:Eu²⁺
Detector Sizes	Same as the predicate	18x24 cm24x30 cm
Pixel Matrix	HM5.0:18x24 cm – 3508x464424x30 cm – 4708x5844	HR-BD:18x24 cm – 3450x474024x30 cm – 4728x5928
Scanning resolutions	50μ	50μ
Acquisition GrayScale (Bit Depth)	16 bit sq. root compression	12 bit logarithmic compression
Displayed Image FileGray Scale	12 bit	12 bit
Maximum ImageAcquisitions/hr.	41 (mammo, 24x30)	65/hr - Profect CS (24x30)40/hr - Profect One (24x30)
Dimensions andWeight	43.5x20x48.4 in.397 lb.	Profect CS• 26x29x58 in.• 628 lb.Profect One• 26x29x52 in.• 529 lb.
Image processing	MUSICA² for Mammography withMicro Calcification Enhancement(MCE)	Dynamic Range Control/Multi-Frequency Processing (DRC/MFP)Pattern Enhancement forMammography (PEM)
X-ray System	Same as the predicate	Legally on the market,Designed specifically formammography
Softcopy Display	Same as the predicate	Legally on the market formammography
Hardcopy Output	Same as the predicate	Legally on the market formammography
Electrical Safety	Same as the predicate	IEC-60601-1

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E. TECHNOLOGICAL CHARACTERISTICS

Agfa's CR Mammography System with DX-M Digitizer consists of:

. Mammography detectors containing phosphor coated image plates that capture the patient image.
. A digitizer which scans the detector and extract the image.
A NX workstation to identify the patient, preview and adjust the image, then direct the . image to where it is needed.

F. TESTING

The new device includes proven technology from the other Agfa computed radiography systems which has been tested to demonstrate its suitability for digital mammography.

The device has been shown to conform to the electronic medical product safety, radiology, and medical imaging standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 6220-1-2, IEC 61223-2-3 and ACR/NEMA PS3.1-3.18 (DICOM). The following management standards have also been applied: ISO 13485, ISO 14971.

Laboratory imaging tests of the new device consistent with IEC 62220-1-2 has been completed. Laboratory tests considered sensitometric response, spatial resolution, noise analysis, dynamic range, erasure, fading, repeat exposures, AEC performance and an evaluation of images from mammography phantoms. Comparisons to the predicate device followed FDA guidance. Test results demonstrated performance equivalent or better than the predicate device.

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Image /page/3/Figure/1 description: This figure shows a plot of DQE [u] vs spatial frequency [mm^-1]. The plot shows two curves, one for 'Slow scan' and one for 'fast scan'. The DQE values range from 0.0 to 1.0, and the spatial frequency values range from 0 to 10. Both curves decrease as spatial frequency increases.

Figure 1 DOE data at ca. 100 µGy exposure level.

An evaluation of clinical images by expert, MQSA qualified radiologists was conducted. Reviewers evaluated breast positioning, exposure, image contrast, sharpness, tissue visibility at the skin line noise and overall clinical image quality. Anonymized images were evaluated to determine if they were of acceptable quality for mammographic use. Reviewers found all studies to be of acceptable overall clinical image quality.

Development of the new device did not involve patient exposures or treatment.

ে CONCLUSIONS

This 510(K) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/4/Picture/0 description: The image contains a circular logo for the Department of Health & Human Services - USA. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract, curved shapes that resemble a person embracing another person.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Agfa HealthCare N.V. % Mr. Phil Cuscuna Regional Regulatory Affairs & QS Manager Agfa HealthCare Corp. 10 South Academy Street GREENVILLE SC 29601

Re: K111324

Trade/Device Name: Agfa's CR Mammography System with DX-M digitizer Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: October 17, 2011 Received: October 19, 2011

Dear Mr. Cuscuna:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known):

Device Name: CR Mammography System with DX-M Digitizer

Indications for Use:

Agfa's CR Mammography System with DX-M Digitizer is indicated for use in diagnostic and screening mammography. It is intended to be used wherever conventional film/screen mammography systems are used.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Richard D'Olier

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(K) K111324

Page 1 of

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.