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The VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

The VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded sutures.
The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3 narrow slots on the handle which holds the suture, which can be press-locked and released. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor.
When the suture anchor is inserted into bone and the inserter is removed, the main sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect using targeted compression zones within the implant sheath for optimal fixation.

This is a 510(k) premarket notification for a medical device called the VersaLoop™ Anchor System. The document does not describe a study involving an AI/ML device. Therefore, it is unable to provide information on acceptance criteria and a study proving the device meets them in the context of an AI/ML model.

This document describes a medical device, specifically a suture anchor system used for soft tissue to bone fixation. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and nonclinical testing, rather than reporting on a clinical effectiveness study or AI/ML performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not applicable or present in this document. The document confirms that nonclinical testing was performed to demonstrate that the VersaLoop™ Anchor System meets established performance characteristics and design requirements.

Summary of available information related to performance:

• Nonclinical test discussion: Nonclinical testing was completed to demonstrate that the VersaLoop™ Anchor System devices meet the established performance characteristics and to verify that design requirements are satisfied.
• Types of testing: Biocompatibility evaluation (per ISO 10993-1), ethylene oxide sterilization validation, Bacterial Endotoxin (BET), dimensional, mechanical (fatigue testing, pullout testing, torque testing, applied forces testing), and functional testing.
• Conclusion from nonclinical tests: "It was concluded from the nonclinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3))."
• FDA Guidance used: "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff."

The acceptance criteria and device performance would be specific to each of these nonclinical tests (e.g., specific tensile strength limits for pullout testing, sterility assurance levels for sterilization validation) but are not explicitly detailed in this summary.

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