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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25 may be used in either arthroscopic or open surgical procedures are anchored to the bone, both may be used to reattach soft tissue, such as ligant capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.

OTS 25 is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene.The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is an FDA 510(k) clearance letter for a medical device called "OTS 25," which is a non-absorbable suture anchor used to reattach soft tissue to bone. It focuses on demonstrating substantial equivalence to predicate devices, not on the performance of an AI system.

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