Search Results

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The OTS 25-L All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint 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-L 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 document is an FDA 510(k) clearance letter for a medical device called "OTS 25-L (100-5)". This letter does not contain any information about the acceptance criteria or reported performance for a software or AI/ML device.

Instead, the document describes a physical medical device (a smooth or threaded metallic bone fixation fastener, specifically an all-suture anchor) and its non-clinical testing for substantial equivalence to a predicate device. The change in this submission (K251310) is a labeling change to allow the device to be packed with autologous bone marrow.

Therefore, I cannot provide the requested information for an AI/ML device based on this input. The output would be:

Based on the provided FDA 510(k) clearance letter for the OTS 25-L (100-5) medical device, there is no information regarding acceptance criteria or a study that proves a software or AI/ML device meets acceptance criteria. The document describes a physical medical device (an all-suture anchor) and its non-clinical testing to support a labeling change.

Ask a specific question about this device