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This device is a digital radiography/fluoroscopy system used interventional angography 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-8000V/B, INFX-8000V/S, V9.5, is an 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/ Ω-arm 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-8000V/B, INFX-8000V/S, V9.5. This document focuses on demonstrating substantial equivalence to a predicate device (Alphenix, V9.1) due to software modifications (V9.1 to V9.5) and integrating previously cleared functions/components.

Crucially, the document explicitly states there are no new indications for use or intended uses of the device, and that the basic system configuration, method of operation, base software, and manufacturing process remain unchanged.

Because the submission is for software changes to an existing device, and not for a new AI/ML-driven diagnostic or assistive device that would require performance validation against clinical endpoints and specific acceptance criteria related to diagnostic accuracy, the provided text does not contain the detailed information necessary to answer points 1-9 of your request.

The study described is not a performance study in the sense of evaluating the diagnostic accuracy of an AI algorithm. Instead, it is a verification/validation testing to demonstrate that the established specifications for the modified device (software update) have been met, and that the device remains as safe and effective as its predicate.

Here's a breakdown of why the requested information is not present and what is stated:

Information Not Present in the Provided Text:

• 1. A table of acceptance criteria and the reported device performance: This would be relevant for a device with a new diagnostic or assistive function whose performance needs to be validated (e.g., sensitivity, specificity, AUC for an AI algorithm detecting disease). For software updates to an existing interventional fluoroscopic X-ray system, the "performance" validated is typically functional and safety-related, not diagnostic accuracy.
• 2. Sample size used for the test set and the data provenance: Not applicable as it's not a diagnostic performance study.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is not an AI-assisted diagnostic device submission.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as it's not an AI/ML device being developed and trained.
• 9. How the ground truth for the training set was established: Not applicable.

What is stated regarding testing and acceptance:

The document indicates that the acceptance criteria are related to safety and functionality of the X-ray system after the software update, ensuring it remains substantially equivalent to the predicate device.

• Testing Method: "Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met."
• Conformance to Standards: "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."
  • Applicable standards listed include: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 62304, IEC 62366-1, IEC 81001-5-1, ISO 17664-2, IEC TR 60601-4-2.
• Grounds for Conclusion of Substantial Equivalence: "Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device."
• Software Validation: "A Basic Documentation Level was determined, per the FDA guidance document, 'Content of Premarket Submissions for Device Software Functions' issued on June 14, 2023, is also included as part of this submission." This indicates that software validation was performed according to FDA guidance for medical device software.

In summary, the provided document is a 510(k) for a software update to an existing fluoroscopic X-ray system, asserting substantial equivalence based on safety, functionality, and compliance with general medical device and X-ray specific standards, rather than a clinical performance study of a novel AI diagnostic algorithm.

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