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The Apollo Knotless Suture Anchors are intended for use in soft tissue to bone fixation in areas such as the shoulder, elbow, knee, hip, wrist, hand, foot, and ankle.

The Apollo Knotless Suture Anchors are made from PEEK (Zeniva ZA-500 and Zeniva ZA-600) per ASTM F2026. The Anchors are provided loaded on individual inserters with and without integrated sutures made of ultra-high molecular weight polyethylene (UHMWPE), sterile, for single use only.

This document is a 510(k) Summary for the Maruho Medical Apollo Knotless Suture Anchor. It details the device, its intended use, and a comparison to predicate devices, but it does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI/machine learning device.

Instead, this document describes a medical device (a suture anchor) and its substantial equivalence to previously cleared predicate devices. The "performance testing" mentioned is related to the physical characteristics of the suture anchor (e.g., pullout strength, fatigue) and material biocompatibility, not diagnostic performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/ML-driven device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because this document is not about an AI/ML-enabled medical device or a diagnostic tool with performance metrics typically associated with such criteria.

The information provided is about a physical implantable medical device and its mechanical/physical performance.

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