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The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.

The CuffLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. There are two sutures loaded through the center of the anchor around, an eyelet at the distal tip of the anchor and back through the center. The suture anchor is mounted on a driver. The CuffLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair.

The CuffLink Suture Anchor is offered in two different sizes with four suture color options. The anchor sizes are 5.5 x 16 mm and 6.5 x 16 mm. Sutures used in the anchor are size # 2 nonabsorbable surgical sutures. The CuffLink driver has a working length of 14 cm with an outer shaft diameter of 3 mm.

This document is a 510(k) Summary for the Cayenne Medical, Inc. CuffLink™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly provided in this type of submission document.

However, based on the provided text, here's what can be inferred or directly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Mechanical testing was performed on the CuffLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the predicate device."

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified for the mechanical testing. The document only mentions "mechanical testing was performed."
• Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer, but the location or whether it involved patient data (retrospective or prospective) is not applicable for this type of mechanical comparison testing.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Mechanical testing for pull-out strength does not involve human experts establishing ground truth in the same way clinical or diagnostic studies do. The "ground truth" would be the objective measurement of pull-out strength.

4. Adjudication Method for Test Set

Not applicable. No expert adjudication method (like 2+1 or 3+1) is mentioned or relevant for mechanical pull-out strength testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a mechanical suture anchor, not a diagnostic or imaging device that would typically involve human readers interpreting results with or without AI assistance. The submission focuses on the mechanical properties of the anchor.

6. Standalone Performance Study

Yes, in a sense. The mentioned "Mechanical testing" on the CuffLink Suture Anchor, comparing its ultimate pull-out strength to a predicate device, is a form of standalone performance evaluation for the device's physical properties. It's algorithm-only performance is not applicable since there is no algorithm involved.

7. Type of Ground Truth Used

The ground truth used for the mechanical testing was objective mechanical test measurements of ultimate pull-out strength. This is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This is a medical device (suture anchor), not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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