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The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair, acetabular labral repair.

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided document is a 510(k) premarket notification for a medical device: Arthrex SwiveLock Anchors. It is primarily focused on demonstrating substantial equivalence to predicate devices for the purpose of a regulatory clearance for an expanded indication (quadriceps tendon repair).

Crucially, this document does not contain information about an AI/ML-driven device or study that would involve acceptance criteria for algorithms, human-in-the-loop performance, or the other specific details requested in your prompt (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment methods for AI).

The "Performance Data" section of this 510(k) summary refers to:

• Static pull-out testing of the Arthrex SwiveLock Anchor and a predicate device.
• Cyclic pull-out testing of the subject device after degradation, compared to a non-resorbable predicate.
• Bacterial endotoxin testing (pyrogen limit specifications).

These are biomechanical and biocompatibility tests for a physical implantable device, not performance metrics for an AI algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets acceptance criteria based on this document. The document describes the regulatory submission for a physical medical device (suture anchors) and its associated mechanical and biological performance, not an AI product.

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