Agfa's DX-D FLFS is a direct radiography accessory, similar to the predicate. The device allows the user to stitch multiple acquired images of long patient anatomies (like a full leg or full spine) into a single patient image. This is particularly useful for making measurements during orthopedic examinations. The DX-D FLFS includes an optional software license for its NX workstation (for image processing) and a patient stand with grid.

AI/ML Overview

The Agfa DX-D FLFS is an accessory for direct radiography systems that allows stitching multiple images of long patient anatomies (like a full leg or full spine) into a single image, useful for orthopedic measurements.

Here's an analysis of its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device meets specifications	Design verification tests confirm the device meets specifications.
Stitching algorithms operate as planned	Stitching algorithms operate as planned.
Expected measurement accuracy achieved	Expected measurement accuracy is achieved.
Performance of complete system validated	Performance of the complete system has been validated.
Conforms to IEC 60601-1 (patient stand)	Patient stand tested according to mechanical hazards in Clause 9 of IEC 60601-1.
Conforms to DIN EN ISO 10993-5 (cytotoxicity)	Not explicitly detailed for the device itself; general product standard compliance mentioned.
Conforms to ISO 14971 (risk management)	Product, manufacturing, and development processes conform to ISO 14971.
Conforms to ISO 13485 (quality management)	Product, manufacturing, and development processes conform to ISO 13485.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document states "Design verification tests confirm the device meets specifications" and "Performance of the complete system has been validated," but it does not provide quantities for test sets or details on the images used.
Data Provenance: Not specified. There is no information provided about the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

Adjudication Method: Not specified. The document does not describe any expert review or adjudication process for establishing ground truth for the test set.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed in the development of the DX-D FLFS." This device is more about image processing and stitching rather than an AI diagnostic aid requiring reader performance comparison.

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

Standalone Study: Yes, in essence, the testing conducted was a standalone performance evaluation of the stitching algorithms and system. "Stitching algorithms operate as planned with expected measurement accuracy. Performance of the complete system has been validated." The device's primary function is automated image stitching, so these tests evaluate the algorithm performs its intended function independently.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for the performance claim of "expected measurement accuracy" is implied to be based on engineering specifications and potentially phantoms or simulated data designed to test the stitching and measurement capabilities. No independent expert review, pathology, or outcomes data is mentioned as ground truth.

8. The sample size for the training set:

Sample Size: Not specified. The document does not provide details on any training data used for the stitching algorithms.

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

Ground Truth Establishment: Not specified. Given the absence of clinical testing and the focus on engineering validation, it's likely the algorithms were developed and refined based on internal technical metrics and potentially synthetic or standardized images, rather than a formally established clinical ground truth for training.

Summary

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5. 510(K) Summary

SEP 13 2012

510(K) SUMMARY: AGFA DX-D FLFS

Common Name: Direct radiography accessory, Full Leg Full Spine application Classification Name: Image-intensified fluoroscopic x-ray system (21CFR892.1650) Proprietary Name: DX-D FLFS Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: July 10, 2012 Telephone: (416) 240-7317 Facsimile: (416) 240-7359

A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for a new version of Agfa's Full Leg, Full Spine imaging accessory, the DX-D FLFS that is compatible with stationary direct radiography systems. The DX-D FLFS is substantially equivalent to the previous version that is used with computed radiography systems.

DEVICE DESCRIPTION B.

Principles of operation and technological characteristics of the new and predicate devices are the same.

C. INTENDED USE

·Agfa's DX-D FLFS is indicated for acquiring images for measurements in the orthopedic field (skeleton).

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's DX-D FLFS has an indications statement that is similar to the predicate, K000159. Their intended uses are the same. The new version works with Agfa's direct radiography systems. The predicate works with its computed radiography systems. Computed radiography and direct radiography systems are both solid-state x-ray imaging devices.

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Agfa HealthCare NV Premarket Notification: DX-D FLFS

Both the new and predicate device include manual and anatomically-based automatic stitching of images. The DX-D FLFS includes a grid based automatic stitching mode as well.

The devices have the same technological characteristics. Descriptive characteristics are adequate to ensure equivalence.

Differences between the new and predicate devices do not alter the intended diagnostic effect.

PRODUCT COMPARISON TABLE
	DX-D FLFS(New Device)	Full Leg Full Spine ImageStitching Software(PREDICATE-K000159)
Detectors	Agfa DR Detectors	Agfa FLFS CR MD4.1 Cassetteand Image Plate.
Patient/Detectorpositioning	DX-D FLFS Stand	CR Full Body Cassette Holder &CR Easylift
Detector Sizes	17x17 in.	14x17 in.
OperatorWorkstation	Same as predicate	Agfa NX
Image stitching	Automatic, grid basedAutomatic, anatomy basedManual	Automatic, anatomy basedManual
Active Matrix	3056x3056	2320x2832
Dynamic Range(acquisition)	14 bit	16 bit, sq. root compressed
Dynamic Range(display)	Same as predicate	12 bit
Operating system	Same as predicate	Windows 7
Display System	Same as predicate	Standard PC display or separatelycleared medical display (e.g.K051901)

TECHNOLOGICAL CHARACTERISTICS E.

Agfa's DX-D FLFS is an accessory for its direct radiography systems. It includes a non-powered patient stand with grid and image processing algorithms in its NX workstation. The device allows the user to automatically or manually stitch multiple acquired images into a single patient image. Use of the accessory requires an optional Full Leg Full Spine user license.

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F. TESTING

Design verification tests confirm the device meets specifications. Stitching algorithms operate as planned with expected measurement accuracy. Performance of the complete system has been validated.

No clinical testing was performed in the development of the DX-D FLFS.

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

PRODUCT STANDARDS

. IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance. (The patient stand only has been tested according to requirements for mechanical hazards described in Clause 9.)
. DIN EN ISO 10993-5: Biological evaluation of medical devices - Tests for in vitro cytotoxicity

MANAGEMENT STANDARDS

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

CONCLUSIONS G.

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 contains a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-00002

SEP 13 2012

Agfa HealthCare N.V. Mr. David Ledwig Principal Consultant Practical Compliance, LLC P.O. Box 1927 BREVARD NC 28712

Re: K122119

Trade/Device Name: DX-D FLFS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: July 10, 2012 Received: July 17, 2012

Dear Mr. Ledwig:

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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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 Division 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,

Janine M. Morris

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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Agfa HealthCare NV Premarket Notification: DX-D FLFS

Indications for Use Form

510(k) Number (if known): _ Kl22119

Device Name: DX-D FLFS

Indications for Use:

Agfa's DX-D FLFS is indicated for acquiring images for measurements in the orthopedic field (skeleton).

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

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

510(k) K122119

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.