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The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use.

The provided text is a 510(k) summary for the Arthrex AlloSync™ PushLock® Suture Anchor, a medical device used for soft tissue fixation to bone. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does not contain information related to a study involving artificial intelligence (AI) or machine learning (ML) models. Specifically, it does not discuss the following:

• Acceptance criteria for an AI/ML model's performance.
• A test set for an AI/ML model.
• Ground truth establishment by experts for an AI/ML model.
• Adjudication methods for an AI/ML model's test set.
• Multi-Reader Multi-Case (MRMC) studies for AI assistance.
• Standalone performance of an AI algorithm.
• Training set for an AI/ML model or how its ground truth was established.

Instead, the performance data discussed in this document relates to the mechanical and biological testing of the physical suture anchor device, comparing its strength, biocompatibility, and pyrogenicity to existing predicate devices.

Therefore, I cannot provide the requested table and study details as the input document does not contain information about an AI/ML device or its performance evaluation.

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