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The proposed Gryphon T and P BR Anchors are intended for:

Shoulder: Rotator Cuff Repair, 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;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;

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

Hip: Capsular repair, acetabular labral repair.

The proposed Gryphon T and P BR Anchors are absorbable suture anchors manufactured of “Biocryl Rapide” material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The Gryphon T and P BR Anchors are provided as size 3.0 mm. Each Gryphon T or P BR Anchor is provided sterile and is for single patient use only.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Gryphon T and P BR Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Gryphon T and P BR Anchors. Instead, it broadly states that "Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use."

The performance testing mentioned is "pull-out performance testing of the sample anchors under real-time aged conditions out to 26 weeks to show that the device meets its product specifications."

Without specific numerical criteria (e.g., "minimum pull-out strength of X Newtons for Y weeks"), a direct comparison table cannot be created.

However, based on the description, a conceptual table would look like this:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The text mentions "pull-out performance testing of the sample anchors." It does not specify the exact number (sample size) of anchors used in this testing.
• Data Provenance: The data provenance is internal testing conducted by the manufacturer, DePuy Mitek. The provided document does not indicate the country of origin of the data beyond the company's location in Raynham, MA, USA. It is a prospective study (performance testing of the new device).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided information. The study described is a mechanical performance study (pull-out strength), not a study requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" for this type of study is the measured physical performance (e.g., force required for pull-out).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Since this is a mechanical performance test, there is no human interpretation or adjudication involved in establishing the test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information describes mechanical performance testing of the device itself, not a study comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device described is a physical bone anchor, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.

7. The Type of Ground Truth Used

The ground truth used for this performance study is objective physical measurement. Specifically, it refers to the measured pull-out performance of the anchors, compared against the "product specifications." This is a direct measurement of the device's mechanical properties, not a subjective assessment, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This section is not applicable. This is a mechanical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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