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The Stabilynx Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tendonesis, Deltoid Repair

· Knee: Extra Capsular Repairs (Medial Collateral Ligament, Lateral Ligament, Posterior Oblique Ligament), Illiotibial Band Tendonesis, Patellar Tendon Repair

· Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment

· Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction

The Stabilynx PEEK Suture Anchor consists of an ethylene oxide sterilized, implantable, poly-ether-etherketone (PEEK) bone screw and ultra high molecular weight polyethylene (UHMWPE) suture anchor is supplied pre-mounted on a disposable Insertion Tool, which consists of a non-patient contact, acrylonitrile butadiene styrene (ABS) handle molded over an externally-communicating, stainless steel shaft. The anchor comes pre-loaded with two (2) high-strength, polyethylene, non-absorbable sutures. The Stabilynx PEEK Suture Anchor design allows a surgeon to create at least one contiguous suture link between one or more adjacent suture anchors after the suture anchors have been inserted into bone. The suture anchor is designed such that one or both of the pre-loaded sutures may be exchanged with one or more sutures connected to an adjacent suture anchor(s).

The provided text describes a 510(k) submission for a medical device called the "Stabilynx PEEK Suture Anchor." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner you might expect for an AI algorithm or diagnostic tool.

Instead, the "acceptance criteria" here refer to various performance metrics and standards that the device must meet to demonstrate its safety and effectiveness, primarily through bench testing, biocompatibility testing, sterilization data, and packaging/shipping validation. The "study" proving the device meets these criteria is the collection of these tests.

Here's the information extracted from the provided text, structured according to your request:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not provide specific sample sizes for each bench test, biocompatibility test, sterilization, or packaging validation. It refers generally to "units" or "devices." This document refers to the data as "performance data" and "bench testing," which implies laboratory-generated data rather than human patient data.

• Sample Size: Not specified for individual tests.
• Data Provenance: Laboratory test data. The country of origin and retrospective/prospective nature are not applicable in the context of these specific tests, as they are engineering and biological evaluations rather than clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. Since this is a physical medical device (suture anchor), "ground truth" is established through physical and chemical measurements against defined engineering and biological standards, not through expert interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human expert review (e.g., for AI model ground truth establishment). The tests described are laboratory-based and follow established scientific protocols for data collection and analysis.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic tools or imaging devices involving human interpretation. The Stabilynx PEEK Suture Anchor is a physical implantable device.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

As mentioned in point 3, "ground truth" in the context of this device's testing is based on:

• Engineering specifications and measurements: For dimensional, visual, torque, and strength tests.
• Established scientific standards and methods: For biocompatibility (ISO 10993-1), sterilization (ISO 11135-1, ISO 10993-7), and packaging (ASTM guidelines).
• Chemical analysis: For EO and ECH residuals.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it.

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