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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.

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.

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:

1. 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."

2. 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.

3. 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.

4. Adjudication method for the test set:

   • Not Applicable/Not Provided: No adjudication method is mentioned as there is no diagnostic 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:

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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