The FDR Go Flex is intended to capture for display radiographic images of human anatomy. It is intended for use in general radiographic applications wherever conventional film/screen or CR systems may be used. The FDR Go Flex is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Device Description

The proposed device, the FDR Go Flex (DR-ID700), is a modification of the Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System, K103596, cleared on 3/29/2011 (submitted as a Special 510(k)) and the Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE), K111548, cleared on 8/30/2011. The FDR D-EVO Flat Panel Detector System (DR-ID600) cleared on 3/29/2011 was a modification of the FDR D-EVO (DR-ID600) Flat Panel Detector, K100762, cleared on 7/15/2010. The FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011.

The FDR Go Flex is a portable digital FPD system that acquires and digitizes x-ray exposures from standard radiographic systems and is designed to be used in any environment that would typically use a radiographic cassette. However, the FDR Go Flex is more portable than its predecessors given its smaller size and ability for all components to operate using battery power in a fully wireless configuration (no cable connections are required between the FDR Go Flex components, although it will remain possible to physically connect components if the user so desires). Note: Only wireless communication is supported between detectors and the Utility Box.

The indirect X-ray conversion method using GOS and CsI Scintillators, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device.

Since the detectors (DR-ID601SE, DR-ID602SE, and DR-ID611SE) are capable of automatically detecting X-ray, direct connection with the X-ray system is not needed.

AI/ML Overview

This 510(k) summary (K120629) for the FUJIFILM FDR Go Flex (DR-ID700) Flat Panel Detector System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance in the way you've outlined.

Here's why and what information can be extracted:

Why the detailed information is not present:

Type of Submission: This is a 510(k) submission, specifically a modification of existing cleared devices. 510(k)s often rely on demonstrating "substantial equivalence" to a predicate device rather than presenting entirely new, extensive clinical studies with human readers and ground truth established by experts. The focus is typically on technical performance and safety, showing that the new device functions similarly to devices already on the market.
Device Type: This is a Flat Panel Detector System, an imaging hardware component, not an AI/CAD diagnostic software. Therefore, the typical acceptance criteria and study designs for diagnostic AI software (e.g., sensitivity, specificity for disease detection, MRMC studies) are not applicable or expected here. The performance is primarily about image quality, safety, and functionality.

Information Extracted from the Document:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied from the document):
  - Successful completion of international IEC testing requirements.
  - Compliance with FDA Draft Guidance Document, Radio-Frequency Wireless Technology in Medical Devices (January 3, 2007) for wireless features.
  - "Substantial equivalence" to predicate devices K103596 and K111548.
  - Image quality maintained (indirect X-ray conversion method using GOS and CsI Scintillators, and FUJIFILM's unique Irradiated Side Sampling design remained unchanged).
  - Automatic X-ray detection capability (a feature cleared in the latest predicate device).
  - Portability and wireless operation as described.
- Reported Device Performance:
  - The device "successfully completed international IEC testing requirements."
  - The device "conforms to applicable medical device safety standards."
  - The device is "substantially equivalent" to predicate devices.
  - The indirect X-ray conversion method and Irradiated Side Sampling design are "delivering high image quality" (stated as unchanged from previous successful devices).
  - All detectors are "capable of automatically detecting X-ray."
  - The device is "more portable than its predecessors given its smaller size and ability for all components to operate using battery power in a fully wireless configuration."
Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided: The document does not describe a "test set" in the context of diagnostic performance (e.g., a set of patient images to be interpreted). The "testing" referred to is for technical performance (IEC standards) and wireless functionality, not clinical image interpretation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided: As there is no clinical "test set" for diagnostic performance, ground truth establishment by medical experts is not detailed or implied in this submission for this type of device.
Adjudication method for the test set:
- Not Applicable/Not Provided: No adjudication method is mentioned as there is no diagnostic test set.
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:
- Not Applicable/Not Provided: This is a fundamental imaging hardware device (flat panel detector), not an AI/CAD system. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this submission and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Provided: This is not an algorithm or AI device, so "standalone" performance in that context is not relevant. The device itself (the detector) operates in a standalone manner to capture images, but its "performance" is in image capture and quality, not diagnostic interpretation.
The type of ground truth used:
- Not Applicable/Not Provided: For the types of tests described (IEC, wireless), "ground truth" would relate to engineering specifications and compliance rather than medical diagnoses.
The sample size for the training set:
- Not Applicable/Not Provided: A "training set" is typically associated with machine learning or AI algorithm development. This document describes a modification to an existing hardware device, not the development of a learning algorithm.
How the ground truth for the training set was established:
- Not Applicable/Not Provided: As no training set is described, no ground truth establishment for it is mentioned.

In summary, this 510(k) submission focuses on demonstrating the safety, technical performance, and substantial equivalence of a new version of an X-ray detector to previously cleared predicate devices, rather than on clinical diagnostic performance data involving human readers or AI algorithms.

Summary

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K120629

Image /page/0/Picture/1 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white and features the word "FUJIFILM" in large, bold letters. Below the main logo, the text "Fujifilm Medical Systems, USA" is written in a smaller font.

AUG 28 2012

510(k) Summary FDR Go Flex (DR-ID700)

Flat Panel Detector System

Date: February 22, 2012

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA

Contact Person:

Name:	Peter Altman
Title:	Regulatory Consultant
Telephone:	(203) 602-3576
Facsimile:	(203) 363-3950

Identification of the Proposed Device:

Proprietary/Trade Name:	FDR Go Flex (DR-ID700)
Classification Name:	Solid State X-ray Imager (Flat Panel/Digital Imager)
Regulations Number:	21 CFR 892.1650
Product Codes:	90 MQB
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Flat Panel Digital Detector

I. INDICATIONS FOR USE

II. DEVICE DESCRIPTION

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Image /page/1/Picture/0 description: The image shows the Fujifilm Medical Systems, USA logo. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used to represent the company's brand.

EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011.

The indirect X-ray conversion method using GOS and CsI Scintillators, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device.

Since the detectors (DR-ID601SE, DR-ID602SE, and DR-ID611SE) are capable of automatically detecting X-ray, direct connection with the X-ray system is not needed.

SUMMARY OF STUDIES III.

The FDR Go Flex flat panel detector system successfully completed international IEC testing requirements. In addition, the FDA Draft Guidance Document, Radio-Frequency Wireless Technology in Medical Devices, issued on January 3, 2007 was followed for the wireless feature.

IV. SUBSTANTIAL EQUIVALENCE

The proposed device, the FDR Go Flex (DR-ID700), is a modification of the Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System. K103596, cleared on 3/29/2011 (submitted as a Special 510(k)) and the Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE), K111548, cleared on 8/30/2011. The FDR D-EVO Flat Panel Detector System (DR-ID600) cleared on 3/29/2011 was a modification of the FDR D-EVO (DR-ID600) Flat Panel Detector, K100762, cleared on 7/15/2010. The FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011. All detectors (DR-ID601SE, and DR-ID611SE) used with the FDR Go Flex are capable of automatically detecting X-ray, a feature cleared in the latest predicate device.

V. CONCLUSION

The FDR Go Flex (DR-ID700) flat panel detector system is substantially equivalent to the cleared predicate devices and conforms to applicable medical device safety standards.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo.

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

AUG 28 2012

Mr. Peter Altman Regulatory Consultant FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD CT 06902

Re: K120629

Trade/Device Name: FDR Go Flex (DR-ID700) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 30, 2012 Received: August 1, 2012

Dear Mr. Altman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 commerce profit it May 26, 1776, the encordance with the provisions of the Federal Food, DINA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmelle Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the device, sabject to the enemal registration, listing of general controls provisions of the Act merelate is and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such alin title 21 II your device is Classified (see above) into enas ffecting your device can be found in Title 21, additional contors. Existing major regulations and the 895. In addition, FDA may publish further Code of Peacharts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumes of a succession is a suith other requirements of the Act that FDA has made a decemmation analy other Federal agencies. You must of any Federal Statutes and regulations administer by not limited to: registration and issting of comply with an the Act Stequirements, therauling, carner called in the 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. Mor

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): K |20 €29

Device Name: FDR Go Flex (DR-ID700)

Indications for Use:

X Prescription Use (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 of Radiological Devices

Page 1 of 1

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.