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Salto Talaris Total Ankle Prosthesis : The Salto Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Components are intended for cemented use only.

Integra XT Revision Ankle Replacement System: The Integra XT Revision Ankle Replacement System is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. Components are intended for cemented use only.

The Integra Salto Total Ankle System (Salto Talaris Total Ankle Prosthesis and the Integra XT Revision Ankle Replacement System) is a semi-constrained anatomical design. Both subsystems consist of two mating components: a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.

This document is a 510(k) premarket notification from the FDA for a medical device called the "Integra Salto Total Ankle System." It's a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the context of an AI-powered diagnostic device, as the prompt requests.

The document discusses the substantial equivalence of the Integra Salto Total Ankle System to a predicate device, based on material, intended use, fundamental scientific technology, and functional/technological characteristics.

Specifically, it states:

• "Nonclinical Performance Data": The Salto Talaris Total Ankle Prosthesis and Integra XT Revision Ankle Replacement System were subjected to verification per standard ASTM F2665 to establish equivalent performance in comparison to the predicate device, covering tests like Tibial Tray Fatigue, Tibial Tray/Insert Locking, Tibial Tray Bone Fixation, Talar Dome Bone Fixation, and Talar Dome Fatigue.
• "Clinical Performance Data": "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device."

Since this is a mechanical orthopedic device clearance and not an AI/diagnostic device, the concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), sample sizes for test sets (in the context of images), expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Therefore, I cannot provide the requested information based on the provided text.

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