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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.

Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty.

The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components.

The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.

The provided text is a 510(k) summary for a medical device, the Exactech® Vantage® Total Ankle Flat Cut Talar Components. It describes the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical testing.

However, the document does not provide information about the acceptance criteria or a study that uses those criteria to evaluate a device's performance in the context of an AI/ML algorithm. The product described is a physical implant for ankle replacement, not a software or AI/ML-driven diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML or algorithm performance.

The non-clinical testing mentioned (Sizing Studies, Cadaveric Study, Bone Stability Testing, Range of Motion Study, Comparative Analysis, Finite Element Analysis, Pyrogen testing) are typical for physical orthopedic implants, demonstrating biological safety, mechanical integrity, and surgical fit, rather than diagnostic accuracy or algorithmic performance against a ground truth.

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