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The Arthrex BioComposite TransFix is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. Fixation with the BioComposite TransFix 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 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, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hand/Wrist: Ligament Scapholunate 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 BioComposite TransFix is very similar to the predicate devices in diameter, and length. The difference lies in the biodegradable material used to manufacture the new model and the addition of a longer device. The implants will be manufactured from PLDLA combined with biphasic calcium phosphate.

The provided text describes the Arthrex BioComposite TransFix device and its substantial equivalence to a predicate device, K062466 (Arthrex Interference Screw): Arthrex Bio-TransFix, rather than a study proving the device meets specific acceptance criteria through clinical performance metrics like accuracy, sensitivity, or specificity.

This submission is a 510(k) Pre-market Notification, a regulatory pathway for medical devices where a new device is shown to be substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" and "device performance" are typically demonstrated through bench testing (mechanical testing) and biocompatibility testing, to show that the new device is as safe and effective as the predicate, not necessarily through clinical studies with human participants to measure traditional diagnostic performance metrics.

Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This was a physical device (implant) undergoing mechanical and biocompatibility testing, not a diagnostic algorithm tested on a dataset. The "test set" would refer to the physical samples of the BioComposite TransFix devices. The exact number of samples used for the mechanical and biocompatibility testing is not specified in this summary, but implied to be sufficient for regulatory demonstration.
• Data Provenance: Not applicable. Material testing data is generated in a lab setting, not from clinical patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth, in the context of diagnostic devices, refers to an established correct diagnosis. For an orthopedic implant, the "ground truth" would be established by the physical and chemical properties of the material, tested against engineering standards (e.g., ISO for biocompatibility, and mechanical strength specifications). This is typically performed by engineers and analytical chemists.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers in interpreting clinical data for diagnostic studies. For material properties, results are typically quantitative and objective, without the need for human adjudication in that sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI/diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is based on engineering standards and physical/chemical properties as determined by ISO 10993-1 for biocompatibility and laboratory mechanical testing for shear strength. The comparative element is against the predicate device's known performance.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. Since there is no training set, there is no ground truth establishment for it.

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