The GR17 is a selenium-based direct conversion DR detector intended for use by a qualified/trained doctor or technician and is designed to perform radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The GR17 is not used for mammography.

Device Description

The GR17 is a 17" x 17" Flat Panel Digital Radiographic Detector for General Radiographic Use. It uses amorphous Selenium (a-Se) as the primary photoconductor.

AI/ML Overview

The provided text is a 510(k) summary for the ANRAD Corporation GR17 Digital Detector, which is an X-ray imager. The submission is for a "Modification to specification for defective pixel detection and correction."

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions a modification to the algorithm for detecting bad pixels and refers to "Pixel defect correction Comparison tests and Results are provided in APPENDIX E." However, the specific acceptance criteria values and the reported device performance in relation to those criteria for the defective pixel detection and correction algorithm are not explicitly stated in the provided text. The text only states that the "Verification Tests were chosen to ensure test coverage of the areas changed in the specifications for pixel defects."

Acceptance Criteria (for defective pixel detection and correction)	Reported Device Performance
Not explicitly stated in the provided text.	Not explicitly stated in the provided text.
(Likely involved thresholds for the number and clustering of defective pixels, and the effectiveness of correction algorithms)	(Likely demonstrated the modified algorithm met the new specifications for pixel defects, as per Appendix E, which is not provided)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "Verification Tests" and "Comparison tests" related to pixel defect correction. These tests would likely involve various X-ray images with simulated or real pixel defects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of human experts to establish ground truth for the test set regarding pixel defect detection and correction. For technical performance metrics like pixel defects, it is more common for ground truth to be established through objective measurements and technical specifications rather than human expert interpretation of images.

4. Adjudication Method for the Test Set:

Given that the ground truth for pixel defects is typically established through objective technical means, an adjudication method like 2+1 or 3+1 involving human readers is not applicable or mentioned in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. This type of study is more relevant for evaluating diagnostic accuracy with human readers, which is not the focus of this particular modification related to pixel defect correction. The submission is for a technical modification rather than a diagnostic performance claim.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study for the pixel defect detection and correction algorithm was implicitly performed. The text states:

"The particular verification tests were chosen to ensure test coverage of the areas changed in the specifications for pixel defects."
"Pixel defect correction Comparison tests and Results are provided in APPENDIX E."

This indicates that the algorithm's performance in identifying and correcting pixel defects was evaluated on its own against specified technical criteria. The results of this standalone evaluation are expected in Appendix E, which is not provided here.

7. Type of Ground Truth Used:

The ground truth used for evaluating the pixel defect detection and correction algorithm would be technical specifications and objective measurements of pixel defects. This would involve:

Deliberately introduced or simulated "defective" pixels.
Pre-defined criteria for what constitutes a "defective pixel" (e.g., dead pixels, stuck-on pixels, clusters).
Objective methods to verify if the algorithm correctly identifies these defects and effectively applies corrections without introducing artifacts.

8. Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. This type of submission, focusing on a modification to a pixel correction algorithm, may not require a separate "training set" in the traditional machine learning sense, especially for algorithms based on predefined rules or thresholds rather than complex learned features. If the algorithm uses machine learning, the training data would be specific to pixel patterns, not necessarily patient images.

9. How Ground Truth for the Training Set Was Established:

Since no training set information is provided, how its ground truth was established is not discussed or applicable based on the provided text.

Summary

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KOSZI 36

510(k) Summary FOR ANRAD Corporation GR17 Digital Detector August 17, 2005 ANRAD Corporation 4950 Levy Street Saint-Laurent (Québec) Canada H4R 2P1 Donald J Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Peabody, MA 01960 Telephone (978) 977-3000 extension 4075 Facsimile (978) 977-6808

Establishment Registration Number:

Device Proprietary Name:

Common Name:

Date:

Submitter's Name:

Submitter's Address:

Submitter's Contact:

Regulatory Class:

Predicate Devices:

Reason for Submission:

Description of device:

Summary of Intended Uses:

Technological Characteristics:

Applied For

GR17 Digital Detector

Solid State X-ray Imager

II (per 21 CFR 892.1650)

ANRAD Corporation GR17 (K042821)

DRC (formerly Sterling Diagnostic Imaging) (K973206)

Modification to specificaton for defective pixel detection and correction.

The GR17 is a 17" x 17" Flat Panel Digital Radiographic Detector for General Radiographic Use. It uses amorphous Selenium (a-Se) as the primary photoconductor.

The GR17 is an amorphous Selenium based direct conversion Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. The GR17 is not used for mammography.

The GR17 employs the same technological characteristics as the predicate devices, differing only in the size of the detector area. The GR17 is 17" X 17" and the DRC detector is 17" X 14".

ANRAD CORPORATION GR17 Digital Detector 510(k) APPENDIX G

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DESIGN CONTROLS 11

The design controls continue to be controlled by ANRAD Corporation. A declaration has been provided in this submission. See page xi of this submission.

11.1 Risk and Hazard Analysis

The Risk and Hazard Analysis, was performed following the change to the algorithm for detection of bad pixels. The conclusion of the Risk and Hazard Analysis is that all hazards that have been adequately mitigated. All identified conditions have been resolved through at least one of the following:

Mechanical Design .
Hardware (Electrical) Design �
. Software Design
Training .
Operating Manual .
Installation Manual ●

The risk and hazards analysis was reviewed for the purpose of identifying the MODIFICATION RISKS, that is, hazards that could possibly be affected by the modifications and any new hazards that could possibly be introduced by the modifications. The selections of the individual verification and validation tests were chosen to cover the risks identified in this review of the modifications. The hazard analysis is provided in APPENDIX B.

Pixel Defects (satisfies section C10 of guidance document) 11.2

See APPENDIX D.

Verification Tests 11.3

The particular verification tests were chosen to ensure test coverage of the areas changed in the specifications for pixel defects. Pixel defect correction Comparison tests and Results are provided in APPENDIX E.

Software Requirements - Level of Concern 11.4

In accordance with FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; May 11, 2005", the software for the GR17 Detector is considered "Minor Level of Concern."

The determination was based on answering "No" to all of the key questions located in Table 1 (Major Level of Concern) and Table 2 (Moderate Level of Concern) of the FDA Guidance Document.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which is a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in a bold, sans-serif font.

Public Health Service

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

ANRAD Corporation % Mr. Donald J. Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive PEABODY MA 01960

AUG 2 3 2013

Re: K052136

Trade/Device Name: GR17 Digital Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 1. 2005 Received: August 5, 2005

Dear Mr. Sherratt:

This letter corrects our substantially equivalent letter of August 25, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocurent of 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 conments 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 1 ou may, deceive, mainer 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 11 your doviet to the believing 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 that I Drime made a sond regulations administered by other Federal agencies. You must of any I collars statutes and regarments, 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 11 you docure specifice 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 Totalliar 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

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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તાવવ

510(k) Number _Kos2136 _______________________________________________________________________________________________________________________________________________________

Device Name: GR17 Digital Detector

Indications For Use:

The Indications For Use has not changed since the original 510(k). NOTE:

Prescription Use X (21 CFR 801 Subpart D)

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AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.