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The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study of acceptance criteria and performance for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided text. The document describes a traditional medical device (suture anchor) and its non-clinical testing for safety and effectiveness, not a computational device with performance metrics typically found in AI/software submissions.

Specifically, the document states:

• Non-clinical Testing: "Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility."
• Safety and Performance: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act."

This indicates that the "acceptance criteria" were essentially demonstrating equivalence to existing predicate devices through mechanical performance testing relevant to a physical suture anchor, as opposed to accuracy, sensitivity, or specificity metrics for an AI system.

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