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The Arthrex Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
• Shoulder: Rotator Cuff Repairs, 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, Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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 3.9mm Corkscrew is a partially threaded suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from either PLLA/BTCP or PEEK and is offered sterile, single use.

The provided document is a 510(k) summary for a medical device (Arthrex 3.9mm Corkscrew Suture Anchor) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance. Instead, it describes:

1. Device Description and Intended Use: The device is a suture anchor used for soft tissue fixation to bone in various anatomical locations and procedures.
2. Comparison to Predicate Device: The submission is a line extension to an existing cleared device (K173788: Arthrex Corkscrew FT) and a reference device (K082810: Arthrex BioComposite Anchors).
3. Performance Data (Non-AI/ML specific): The data presented refers to mechanical (pull-out) and biocompatibility testing, along with bacterial endotoxin testing. This is standard for a mechanical implant and not related to AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information provided pertains to a traditional medical device submission, not an AI/ML diagnostic or assistive technology.

If you have a document describing an AI/ML device study, please provide that, and I will do my best to answer your questions.

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