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The Cayenne Medical, Inc. SureLock™ W Suture Anchors is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.

The SureLock™ W Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone. The suture anchor is preloaded with floating suture and loaded on a disposable inserter. The SureLock™ W Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures.

The SureLock™ W Suture Anchor is offered in one size, 2.5mm. The anchors are made out of non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical suture, PolyEtherEtherKetone (PEEK), and L-lactide/glycolide copolymer (PLGA). The floating sutures are made out of size 2 non-absorbable UHMWPE surgical sutures. The suture anchor is pre-loaded with two floating sutures.

The disposable inserter has a working shaft length of 22.2 cm with an outer shaft diameter of 4.6mm. The inserter shaft is made out of surgical grade stainless steel and the handle and knob are made out of ABS plastic. The inserter pushes the suture anchor into a hole drilled in the bone. The knob on the inserter handle is rotated to apply tension to the floating sutures to expand and deploy the anchor in the bone tunnel. When the knob is fully rotated, the floating suture limbs are released from the inserter and the inserter is removed.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (SureLock™ W Suture Anchor) and details its administrative information, device description, intended use, and comparison to a predicate device.

It explicitly states:

• "Clinical testing was not used to establish substantial equivalence to predicate device."
• It focuses on non-clinical testing (biocompatibility and mechanical testing) to demonstrate functionality and safety.

Therefore, the document does not include:

• A table of acceptance criteria and reported device performance related to a study proving acceptance criteria.
• Details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for test or training sets.

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