(261 days)
The XGEO GU60A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The XGEO GU60A digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.
The provided text describes a 510(k) premarket notification for the "XGEO GU60A Digital Diagnostic X-ray System." It outlines the device's intended use and compares it to a predicate device, but it does not contain acceptance criteria or a study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Revolution XR/d of General Electric Company) for regulatory purposes. It mentions various tests conducted for safety, EMC, and performance according to established standards (e.g., IEC 60601 series, 21 CFR 1020.30, 21 CFR 1020.31, and FDA guidance for 510(k)s for Solid State X-ray Imaging Devices). It states, "All test results were satisfied," which implies the device passed, but it does not specify what those acceptance criteria were or present the detailed results of those tests.
Therefore, most of the requested information cannot be extracted from this document, specifically:
1. A table of acceptance criteria and the reported device performance: Not provided. The document states "All test results were satisfied" for safety, EMC, and performance tests, but does not list specific criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The document mentions "Non-clinical testing and Clinical Testing were conducted," but gives no details about sample size, provenance, or study design.
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): Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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 explicitly stated. The device is a "Digital Diagnostic X-ray System" for generating images, not an AI-powered diagnostic aid that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely for this type of device as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a hardware system for image acquisition, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, as detailed clinical study results are absent.
8. The sample size for the training set: Not provided. This device is an X-ray imaging system, not an AI model that typically requires a training set in the same context.
9. How the ground truth for the training set was established: Not provided. (See point 8).
Summary of what is present:
- Device Name: XGEO GU60A Digital Diagnostic X-ray System (K123106)
- Intended Use: Generating radiographic images of human anatomy by a qualified/trained doctor or technician. Not for mammographic applications.
- Predicate Device: Revolution XR/d of General Electric Company.
- Studies Conducted (mentioned, not detailed): Electrical, mechanical, environmental safety and performance testing according to IEC 60601 series, 21CFR1020.30, 21CFR1020.31; EMC testing according to IEC 60601-1-2(2001); Non-clinical testing and Clinical Testing in accordance with FDA guidance for 510(k)s for Solid State X-ray Imaging Devices.
- Conclusion: The device is safe and effective and substantially equivalent to the predicate device, with all test results reported as "satisfied."
§ 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.