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The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,

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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The Arthrex FastThread Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.

The provided document is a 510(k) Summary for a medical device, the Arthrex FastThread Interference Screw. It outlines the device's indications for use, its comparison to predicate devices, and the performance data submitted for its clearance.

However, the information provided does not contain details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for an AI/ML-based medical device study.

Instead, this document describes the regulatory submission for a physical, implantable medical device (an interference screw) and its mechanical and biological performance data. The "Performance Data" section specifically states:

• "Mechanical testing demonstrated that the pull-out strength of the proposed Arthrex FastThread Interference Screw met the acceptance criterion established by K201749 for MPFL repair/reconstruction."
• "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that the acceptance criteria and study proving the device meets them are related to the physical properties and safety of the implantable screw, not to the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML device performance from this document. The questions posed in your prompt (e.g., "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set ground truth") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

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