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 radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Device Description

The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use.

AI/ML Overview

The provided text is a 510(k) summary for the ANRAD CORPORATION GR17 Digital Detector, submitted in 2004. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on clinical and non-clinical testing. However, the document does not provide specific acceptance criteria or detailed results from the studies that prove the device meets such criteria.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

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

Cannot Populate. The 510(k) summary states "Based on the Clinical Study Report dated September 8, 2004, the GR17 Digital Detector is substantially equivalent to the predicate device." and "The testing of the GR17 Digital Detector demonstrates that the performance is substantially equivalent to the predicate devices cited above." However, it does not define specific acceptance criteria (e.g., a certain sensitivity/specificity, SNR, MTF values) nor does it report specific performance metrics against any such criteria. It only asserts substantial equivalence.

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

Cannot Populate. The document mentions a "Clinical Study Report dated September 8, 2004" but does not provide any details about the sample size, type of study (retrospective/prospective), or data provenance.

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)

Cannot Populate. This information is not present in the provided text.

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

Cannot Populate. This information is not present in the provided text.

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

Cannot Populate. This information is not present in the provided text. The device is a "Solid State X-Ray Imager (Flat Panel / Digital Imager)", meaning it's a hardware detector, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable to this device type. The document states it is "intended to replace radiographic film/screen systems," implying a comparison to traditional film.

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

Cannot Populate. The device is a hardware detector, not an algorithm. Standalone performance for an algorithm is not applicable here. The "performance" mentioned would refer to the image quality characteristics of the detector itself.

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

Cannot Populate. This information is not present in the provided text.

8. The sample size for the training set

Cannot Populate. This information is not present in the provided text. As this is a hardware device (detector), the concept of a "training set" in the context of machine learning is not directly applicable. If it refers to data used to optimize hardware parameters, that information is not provided.

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

Cannot Populate. (See point 8).

Summary

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K04.282i

OCT 2 2 2004

info@ 510(k) Summary For ANRAD CORPORATION

GR17 Digital Detector

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92

1. Submitter's Name and Address:
  ANRAD CORPORATION 4950 Levy Street Saint-Laurent (Québec) Canada H4R 2P1
1. Date this Summary was Prepared:
  September 24, 2004
1. Submission Correspondent:
  Donald J Sherratt Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Peabody MA 01960 (978) 977-3000 extension 3049 Telephone Facsimile (978) 977-6808

4. Device Name:

Proprietary or Trade Name:	GR17 Digital Detector
Common Name:	Solid State X-Ray Imager (Flat Panel / Digital Imager)
Classification Name:	Solid State X-Ray Imager
Classification Panel:	Radiology

ર. Predicate Devices:

The legally marketed devices to which equivalence is being claimed are:

The Sterling Diagnostic Imaging Direct Radiography (K973206) and the Fuji Computed Radiography System FCR9000HQ (K951373).

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6. Device Description

The GR17 is a 17 inch by 17 inch digital delector. It is intended to convert X-rays into efectrical signals to create usable images for diagnostic use. The dimensions of the GR 17 are below:

Overall length	574 mm
Overall width	502 mm
Overall height	32.3 mm
Weight	10.5 kg

Table 4: GR17 Dimensions

7. Intended Use

Comparison of Technological Characteristics: 8.

The design of the GR17 Digital Detector has the same technological characteristics as the predicate devices.

9. Clinical and Non-Clinical Testing

9.1 Conclusions from Clinical Testing

Based on the Clinical Study Report dated September 8, 2004, the GR17 Digital Detector is substantially equivalent to the predicate device.

Conclusions from Non-clinical Testing 9.2

The testing of the GR17 Digital Detector demonstrates that the performance is substantially equivalent to the predicate devices cited above.

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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 a stylized human figure in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the human figure. The logo is simple and professional, and it is easily recognizable.

Public Health Service

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

Anrad Corporation % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA. Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

AUG 2 3 2013

Re: K042821

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: October 8. 2004 Received: October 12, 2004

Dear Mr. Lehtonen:

This letter corrects our substantially equivalent letter of October 22, 2004.

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

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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rad

510(k) Number Ko42824

Device Name: GR17 Digital Detector

Indications For Use:

Prescription Use x (21 CFR 801 Subpart D)

ARD/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 (ODL)

David A. Lyon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KD42821 510(k) Number

September 24, 2004 Page xvii of xxi

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.