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The Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four components (Tibial Plate, Liner, Talar Component and Locking Component).

The predicate Vantage Fixed Bearing Liners are constructed of compression-molded UHMWPE. This submission proposes Vantage Fixed Bearing Liners made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Fixed Bearing Liners as well as additional Fixed Bearing Liner thickness options.

The provided text is a 510(k) summary for a medical device, the Vantage® Total Ankle System, specifically an orthopedic implant for ankle replacement. It does not describe an AI/ML-driven medical device or a study involving human readers or ground truth for image analysis. Therefore, it is impossible to extract the information requested in the prompt, as those details relate to the validation of AI/ML systems, which is not the subject of this document.

The document focuses on demonstrating substantial equivalence of a new version of the ankle system (with vitamin E-containing UHMWPE liners and minor geometric changes) to a previously cleared predicate device. It relies on non-clinical testing and engineering analyses (material characterization, wear, range of motion, stability, disassembly, biocompatibility, bacterial endotoxins) to show that the changes do not adversely affect safety or effectiveness.

Thus, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set information, as this document is not about an AI/ML medical device.

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