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The Arthrex SwiveLock Suture 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, SLAP Lesion 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, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for 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 sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted 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 text is a 510(k) Summary for the Arthrex SwiveLock Suture Anchor, a medical device for orthopedic fixation. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory submission to the FDA, not a study report on the performance of an AI/ML powered device, therefore, it does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The sections you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in documents related to the validation and performance evaluation of AI/ML software as a medical device (SaMD). This 510(k) is for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence through mechanical testing and biocompatibility.

Therefore, I cannot extract the requested information from the provided text.

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