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The Anatomical Bankart Tack™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Anatomical Bankart Tack™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

The Anatomical Bankart Tack™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Anatomical Bankart Tack is composed of 100% poly-L-lactide ("PLLA") polymer, its length is 20mm and diameter 3.5mm.

The provided text is a 510(k) summary for the Bionx Implants Inc. Anatomical Bankart Tack, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria. The document explicitly states:

"The Anatomical Bankart Tack™ is substantially equivalent to the cleared Bionx Bankart Tack™ (K973849). Both devices have intended use, similar principles of operation and technological characteristics. Furthermore, the minor technological differences between the Anatomical Bankart Tack™ and the predicate devices do not raise any new issues of safety or effectiveness."

Therefore, based on the provided text, I cannot extract the information required for your request. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts, or adjudication methods for ground truth establishment.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (beyond implying equivalence to a predicate).
• Details about a training set, its sample size, or how its ground truth was established.

This is a regulatory submission for substantial equivalence, which typically involves showing similarity to an already approved device, often through bench testing and sometimes limited clinical data, but not necessarily a comprehensive study demonstrating new performance against defined acceptance criteria in the way you've outlined for an AI/diagnostic device.

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