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Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction Hip: Capsular Repair, Acetabular Labral Repair

The proposed device is a suture-anchor to be used for soft tissue fixation to bone. The Gryphon Anchor is a cannulated, ribbed anchor, made of either non-absorbable PEEK (Polyetheretherketone) or absorbable Biocry18 Rapide " (composite of ß-TCP and PLGA copolymer). Orthocord suture (absorbable polydioxanone (PDS®) and non-absorbable polyethylene braided composite suture) is preloaded on the anchor. The suture incorporates a pre-tied sliding knot (ProKnot knot). The device is provided as sterile; the device is for single patient use only.

The provided text describes a 510(k) summary for the GRYPHON™ ANCHOR w/PROKNOT™ TECHNOLOGY. This is a medical device, specifically a suture-anchor for soft tissue fixation to bone. The summary details its classification, predicate devices, and indications for use.

However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results as would be typical for a new, non-equivalent device. The information available about performance testing is limited.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only mentions "fixation force testing was conducted." The number of samples tested is not quantified.
• Data Provenance: The testing was "in vitro." The country of origin for the data is not specified, but the applicant is DePuy Mitek, a Johnson & Johnson company, located in Raynham, MA, USA, suggesting the testing was likely conducted in the US or by a contracted lab. The testing is non-clinical.

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

There is no mention of experts or ground truth establishment in the context of clinical studies for this device. The documentation focuses on non-clinical performance testing and comparison to predicate devices, which does not typically involve expert review of clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was non-clinical testing, not a clinical study involving adjudication of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and 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 implant (suture anchor), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For fixation force testing: The "ground truth" would be the measured physical properties of the device (e.g., pull-out strength, stiffness) compared against pre-defined engineering specifications or the performance of the predicate device. This is based on objective measurement rather than expert consensus or pathology in a clinical sense.
• For material biocompatibility: This typically involves established biocompatibility testing standards (e.g., ISO 10993 series) which determine if the material elicits an adverse biological response.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of physical medical device submission, as it does not involve machine learning or AI models.

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

Not applicable.

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