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The Synthes Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

The Synthes Ankle Arthrodesis Plates are minimally contoured metal plates that utilize traditional internal plate/screw fixation to promote fusion or "arthrodesis" of the ankle.

This document is a 510(k) summary for the Synthes Ankle Arthrodesis Plates. It describes a medical device, its intended use, classification, and a determination of substantial equivalence to a predicate device by the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not a performance study report for a novel AI/software medical device.

Therefore, I cannot provide the requested information in the format specified because the provided text does not contain the details of a study on device performance against acceptance criteria. The document is for a traditional medical device (metal plates) and focuses on regulatory clearance based on substantial equivalence, not on performance metrics of a software or AI algorithm.

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