(24 days)
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
The Alphenix, INFX-8000F/B, V8.0, is a single or dual plane X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm (either one or two) which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
The provided text is a 510(k) summary for the Alphenix, INFX-8000F/B, V8.0, an X-ray system. It describes changes made to a previously cleared device. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI-powered medical device's performance evaluation.
Specifically, the document states:
- "This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system."
- "Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems."
- "Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrates that the requirements for the modifications made to the system have been met."
- "Additionally, Image Quality metrics utilizing phantom image evaluations were employed in bench testing which demonstrates that the requirements for the modifications made to the system have been met."
- "Software Documentation for a Moderate Level of Concern... is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform."
The summary lacks the specific details required for the requested table and study information, particularly concerning numerical performance metrics, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, which are typical for AI/ML device performance claims. The changes described are primarily related to hardware components, system software versions (for "improved usability"), and workflow enhancements for the X-ray system itself, not the performance of a new AI-driven diagnostic algorithm.
Therefore, I cannot generate the requested table and detailed study description based solely on the provided text. The document refers to "test data," "risk analysis," "verification/validation testing," and "Image Quality metrics utilizing phantom image evaluations," but it does not specify the quantitative acceptance criteria or the numerical results of these tests in a way that aligns with the questions asked (e.g., sensitivity, specificity, or reader improvement with AI assistance).
If this document were for an AI/ML device making diagnostic claims, the level of detail regarding performance testing would be much higher, including specific metrics and study designs that involve human readers or ground truth derived from expert consensus/pathology.
The questions you've asked are highly relevant for the regulatory review of AI/ML-driven medical devices. However, this specific 510(k) summary (K182415) seems to be for an imaging system with software/hardware updates, not necessarily an AI-powered diagnostic algorithm that would require the in-depth clinical performance validation often associated with AI.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.