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The GRYPHON PEEK Anchor is intended for: Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular repair, acetabular labral repair.

The Gryphon PEEK Anchors are non-absorbable threaded suture anchors manufactured of PEEK material. The barbed anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The Gryphon PEEK Anchor is provided as size 3.0mm. The Gryphon PEEK Anchors will be offered with partially absorbable Orthocord suture options, similar to the Gryphon P BR Anchor. Technologies characteristics including design and packaging are the same as the predicate cleared devices.

The provided text is a 510(k) summary for a medical device called the "Gryphon PEEK Anchor." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment methods for a new study is not present in this document.

The study described here is primarily a comparative assessment to existing, legally marketed devices (predicates) to establish substantial equivalence.

Here's what can be extracted from the document in relation to your questions, and what cannot:

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

• Not explicitly provided as a table with specific quantitative acceptance criteria or a detailed breakdown of reported performance values.
• The document states: "Non clinical Testing Verification activities were performed on the implant or its predicates. Testing assessments include pull out testing, shelf-life, sterilization and biocompatibility. Safety and Performance Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
• This indicates that mechanical performance (pull-out strength) and other safety aspects were tested, and the results were found to be comparable to existing devices, satisfying the "substantial equivalence" criteria for regulatory approval. However, no numerical values or specific thresholds are given.

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

• Not specified. The document mentions "pull out testing" but does not give sample sizes, origin of data, or details on whether the testing was conducted on clinical samples or benchtop models.

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)

• Not applicable/Not specified. This scenario is for a mechanical device; "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant here. Device performance is determined by engineering tests (e.g., measuring pull-out force).

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

• Not applicable/Not specified. See point 3.

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

• Not applicable. This device is a surgical anchor, not an AI or imaging diagnostic tool. An MRMC study would not be relevant.

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

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

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

• Mechanical testing results. The "ground truth" for a device like this would be derived from objective engineering measurements (e.g., the force at which the anchor pulls out of bone substitute).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set."

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

• Not applicable. See point 8.

In summary:

The document describes a 510(k) submission for a non-absorbable threaded suture anchor. The "study" mentioned is focused on "Non clinical Testing Verification activities... includ[ing] pull out testing, shelf-life, sterilization and biocompatibility." The primary conclusion drawn from these activities is that the device is "substantially equivalent to predicate devices." This type of regulatory submission does not typically involve the detailed breakdown of performance metrics, sample sizes, and ground truth establishment methods that would be seen in an AI or diagnostic study.

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