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The Arthrex 2.5 mm Tenodesis Screw is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex 2.5 mm Tenodesis Screw is a fully threaded, cannulated screw with a rounded head. The screw will be offered in a 2.5 mm diameter and 6 mm length. The screw is manufactured from Polyetheretherketone (PEEK). The screw is sold as sterile, single-use.

The provided text describes the regulatory filing for a medical device, the Arthrex 2.5 mm Tenodesis Screw, and its substantial equivalence to predicate devices. It does not contain information about an AI/ML-based device, nor does it detail acceptance criteria or studies related to AI/ML performance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI/ML device test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done for an AI/ML device.
• Whether standalone (algorithm-only) performance was done for an AI/ML device.
• The type of ground truth used for an AI/ML device.
• Sample size for an AI/ML device training set.
• How ground truth for an AI/ML device training set was established.

The document discusses performance data for the Arthrex 2.5 mm Tenodesis Screw in terms of mechanical testing (pull-out and failure torque/insertion torque), sterilization (ethylene oxide with a SAL of 10⁻⁶), shelf life (5 years for PEEK material), and biocompatibility testing (Bacterial Endotoxins Test, Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, and Material Characterization). The acceptance criteria for these tests are implicitly that the new device performs "statistically equivalent" to the predicate device for mechanical properties and meets established standards (e.g., ISO 10993-1:2018 for biocompatibility, ANSI/AAMI ST72:2011/(R)2016 for sterility).

In summary, the provided document is for a traditional medical device (a mechanical screw) and does not involve AI/ML. Thus, the specific questions about AI/ML device evaluation metrics cannot be answered from this text.

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