Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

Device Description

Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:

Phosphor coated imaging plates and cassettes for image capture.
Laser digitizer for generating the electronic image. .
NX workstation for image previewing, processing and routing .

AI/ML Overview

Given the provided text, the Agfa Computed Radiography (CR) Systems with CR 10-X Digitizer is a medical imaging device. The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Agfa's CR 30-X digitizer, K062223) rather than proving performance against specific acceptance criteria in a quantitative study with detailed metrics.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in terms of numerical performance thresholds. Instead, the approach is based on demonstrating that the new device (CR 10-X Digitizer) is "substantially equivalent" to the predicate device (CR 30-X Digitizer). The "performance" is generally described as "similar" or "same as predicate" in terms of technological characteristics and image quality.

Acceptance Criteria Category	Reported Device Performance (CR 10-X Digitizer)
Intended Use	Same as predicate (general projection radiographic applications, diagnostic quality images, not for mammography)
Technological Characteristics	Largely the same as predicate (e.g., phosphor coated imaging plates, laser digitizer, NX workstation, scanning technology, light collection, scanning resolution (100μ), dynamic range acquisition (16 bit), image processing (MUSICA, MUSICA2), dynamic range display (12 bit)). Minor differences (e.g., active matrix slightly different, throughput (34 plates/hr) is lower than predicate (60 plates/hr), cassette sizes are fewer). These differences "do not alter the intended therapeutic/diagnostic effect."
Image Quality	"Meets specifications and operates as planned" with internal and experts comparing the device to its predicate. (No specific quantitative metrics or thresholds provided.)
Safety and Standards Compliance	Conforms to IEC 60601-1, IEC 60601-1-2, ACR/NEMA PS3.1-3.18 (DICOM), ISO 14971, ISO 13485.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Tests included image quality tests with internal and experts comparing the device to its predicate." However, it does not specify the sample size for any test set (e.g., number of images, number of patients).

The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions "experts comparing the device to its predicate" for image quality tests. However, it does not specify the number of experts or their qualifications (e.g., specialty, years of experience).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for establishing ground truth or comparing device performance. It simply states "internal and experts comparing the device to its predicate."

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a CR digitizer, not an AI-powered diagnostic tool, so the concept of human readers improving "with AI vs without AI assistance" is not applicable here. The study described is a comparison of the new hardware device to a predicate hardware device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself. The document states that "The device has completed verification and validation testing to confirm it meets specifications and operates as planned." This includes image quality tests. While it's not an "algorithm only" in the sense of AI, it represents the standalone performance of the imaging system. However, specific performance metrics for this standalone performance (beyond technological characteristics) are not detailed other than being compared by experts to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For image quality tests, the "ground truth" or reference for comparison appears to be the predicate device's image quality, as assessed by "internal and experts." This suggests a form of expert opinion or visual comparison, rather than an objective "ground truth" like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set as this is a hardware device (CR digitizer) and not an AI/machine learning algorithm that typically requires a training set.

9. How the ground truth for the training set was established

Since there is no mention of a training set, this information is not applicable.

Summary

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K121948

JUL 20 2012

Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer

510(K) SUMMARY

Agfa Computed Radiography (CR) Systems with CR 10-X Digitizer

Common Name: Computed Radiography System Classification Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Classification: 21 CFR 892.1650 Product Code: MQB Proprietary Name: Computed Radiography (CR) Systems with CR 10-X Digitizer Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: April 10, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's Computed Radiography (CR) System with CR 10-X Digitizer, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's CR 30-X digitizer (K062223).

B. DEVICE DESCRIPTION

Phosphor coated imaging plates and cassettes for image capture.
Laser digitizer for generating the electronic image. .
NX workstation for image previewing, processing and routing .

C. INTENDED USE

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

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Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa"s Computed Radiography (CR) System with CR 10-X Digitizer has an Indications For Use statement similar to the statement for the predicate device, K062223. 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.

PRODUCT COMPARISON TABLE
	Systems with CR 10-X Digitizer(New Device)	Systems with CR 30-X Digitizer(PREDICATE-K062223)
Communications	Same as predicate	DICOM
Cassette and Image Plates
Cassettes and ImagePlate Sizes	35x43 cm	15x30 cm18x24 cm24x30 cm35x35 cm35x43 cm
Image Plate Phosphors	Same as predicate	BaSrFBrI:Eu
Digitizer
Scanning technology	Same as predicate	Point at-a-time
Light collection	Same as predicate	Solid, high efficiency
Scanning resolution	Same as predicate	100μ
Active matrix	3420 x 4218	3480 x 4248
Dynamic range(acquisition)	Same as predicate	16 bit, sq. root compressed
Throughput(35x43 cm plates/hr.)	34	60
Power Supply	Same as predicate	100 - 240V 50/60 Hz
Mobile installations	Same as predicate	Mobile mounting option
Image stitching	Same as predicate	Full Leg Full Spine
Workstation
Image processing	Same as predicate	MUSICA, MUSICA2
Dynamic range(display)	Same as predicate	12 bit
Operating system	Windows 7	Windows XP Pro
Power Supply	Same as predicate	100 - 240V 50/60 Hz
Display System	Same as predicate	Standard PC display or separately clearedmedical display

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E. TECHNOLOGICAL CHARACTERISTICS

Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. It uses phosphor coated imaging plates to capture an x-ray exposure. Upon scanning of the image plates by the CR-10-X digitizer, the x-ray image is read and transmitted to the NX workstation where the image can be previewed, processed and transmitted to other devices for viewing, printing or storage.

F. TESTING

The device has completed verification and validation testing to confirm it meets specifications and operates as planned. Tests included image quality tests with internal and experts comparing the device to its predicate.

The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including:

PRODUCT STANDARDS

. IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, plus collateral standard: Electromagnetic compatibility requirements and tests.
IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety -. Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
. ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM)

MANAGEMENT STANDARDS

. ISO 14971 Application of Risk Management to Medical Devices
. ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes

G. 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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

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

JUL 20 2012

Agfa Healthcare N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K121948

Trade/Device Name: CR 10-X Digitizer Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: July 2, 2012 Received: July 3, 2012

Dear Mr. Job:

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 ror association 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 or uny 1 vith 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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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirenchs as set forth in the quality of over as described in your Section 510(k) premarket whil anow you to ocgainmarketing your substantial equivalence of your device to a legally marketed nonication. The I Drice 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 11 you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, productions are regarding the 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 other other geficiturers, 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,

Janine M. Morris

Acting 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 Form

510(k) Number (if known):

Device Name: CR 10-X Digitizer

Indications for Use:

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

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)

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

21(

Page 1 of

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.