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The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.

The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument.

The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter

The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.

The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.

The provided text describes a 510(k) premarket notification for the "SAPPHIRE MEDICAL, INC. CINCH™ BONE ANCHOR SYSTEM." This documentation focuses on demonstrating substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with detailed acceptance criteria and performance metrics for a novel medical device. Therefore, the information typically requested in an AI/Software as a Medical Device (SaMD) context (such as detailed acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies) is largely not applicable to this submission.

Here's a breakdown of the available information:

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

   Acceptance Criteria	Reported Device Performance
   Meets specifications and does not raise new issues of safety or effectiveness.	"Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended." (Performance Data section) Additionally, the submission argues "The minor technological differences between the CINCH Bone Anchor System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH Bone Anchor System is as safe and effective as the predicate devices." (Substantial Equivalence section)
   Biocompatibility	"The materials used in the CINCH Bone Anchor System are biocompatible. The same materials are commonly used in similar medical devices." (Biocompatibility Data section)
   Substantial Equivalence to predicate devices	The entire submission is focused on demonstrating substantial equivalence in intended use, indications, technological characteristics, and principles of operation to listed predicate devices (DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus, Arthrex, Inc.'s PEEK Corkscrew FT, Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor, and Linvatec Corporation's UltraFix® RC). The FDA concurrence letter confirms this finding: "...determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

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 submission refers to "bench testing" without providing details on the number of anchors tested, the specific testing protocols, or any human/animal data. It's highly likely this was purely lab-based mechanical testing.

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. This is a medical device, not an AI or imaging diagnostic device requiring expert interpretation for ground truth.

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

   • Not applicable. This is a medical device, not an AI or imaging diagnostic device.

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 a physical bone anchor, not an AI-assisted diagnostic or therapeutic device.

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

   • No. This is a physical bone anchor. Performance relates to its mechanical properties and function as a surgical implant, not an algorithm.

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

   • For this type of device (bone anchor), "ground truth" for performance would be established by engineering specifications, mechanical testing standards, and possibly cadaveric studies to assess surgical technique and initial fixation. The document states "bench testing" results met specifications.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

   • Not applicable.

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