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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular labral repair.

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid of polyester with a single or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

The provided text is a 510(k) Summary for the Arthrex FiberTak Suture Anchor. It describes a medical device, not an AI/ML powered device, therefore, the information requested in the prompt is not available in the provided text. The submission is for a line extension of an existing predicate device and focuses on establishing substantial equivalence through mechanical testing, not through clinical or reader studies involving AI.

Specifically, the document states:

• Purpose of Submission: "This Special 510(k) premarket notification is submitted to obtain clearance for the self-punching Arthrex FiberTak Suture Anchor as a line extension to the Arthrex FiberTak Suture Anchor devices cleared under K181769."
• Performance Data: "Ultimate load and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate."

Therefore, I cannot extract information related to acceptance criteria and studies proving the device meets those criteria from an AI/ML perspective because this is a mechanical device submission.

If you have a document describing an AI/ML powered medical device, I would be happy to provide the requested information.

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