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The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.

The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.

I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the OIC Suture Anchor System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, as typically described for AI/ML-based medical devices.

This document is for a traditional, physical medical device (suture anchor system) and primarily establishes substantial equivalence to predicate devices based on:

• Indications for Use: The OIC Suture Anchor System is intended for fixation of soft tissue to bone and supports specific procedures (Shoulder, Elbow, Knee).
• Technological Characteristics: It compares the OIC device's design (PEEK plastic anchors, eyelet, screw-like) and materials (PEEK, stainless steel, aluminum for instruments) to predicate devices.
• Performance Testing: It briefly mentions "Mechanical testing was conducted to ascertain that the suture acceptable characteristics for the intended uses." This is a general statement and does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for the specific information points related to acceptance criteria and a study proving device performance, especially in the context of AI/ML devices (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) from the provided text.

The document details the FDA's clearance process for physical devices, focusing on substantial equivalence, rather than the rigorous performance validation typically required for AI/ML algorithms.

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