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The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults.

The Activ Ankle Locking Plating System consists of a plate with many screws as holes (slots) designed for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults. The plates and screws are manufactured from titanium alloy and color anodized. Washers are also available for use with syndesmosis screws. The Activ Ankle Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.

This document describes the 510(k) premarket notification for the "Activ Ankle Locking Plating System," a medical device, and therefore does not contain information about software or AI-enabled insights, acceptance criteria, or study results in the context of AI/ML performance.

The document discusses the device's intended use, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices, as required for FDA 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies because this document is about a bone fixation device and does not involve AI or clinical performance studies of an AI algorithm.

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