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FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

FLXIS is a family of image detection components including image intensifiers, a camera, an image processing functionality and a remote control user interface, of which several an inage probeconfigured. Each configuration can be delivered with a display module.

This Philips Medical Systems 510(k) summary for the FLXIS device, primarily focuses on demonstrating substantial equivalence to a predicate device (OmniDiagnost Eleva) rather than presenting a detailed study proving performance against explicit acceptance criteria. The document does not contain the information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The summary states: "FLXIS does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems Nederland B.V. considers FLXIS to be substantially equivalent with the predicate device." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to an already cleared device, not through new performance testing against specific quantitative acceptance criteria as would be typical for a novel device or a modified device undergoing performance evaluation.

Therefore, I cannot provide the requested table or answer the specific questions about the study design because the provided document does not contain this information. The document is a 510(k) submission summary for regulatory clearance based on substantial equivalence.

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