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The Arthrex SutureTape is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.

Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Arthrex SutureTape." This document details the regulatory clearance for a surgical suture and focuses on demonstrating substantial equivalence to previously cleared devices.

Crucially, this document does not describe acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria. It pertains to a physical medical device (suture) and its mechanical and biocompatibility testing. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and study details for an AI/ML device.

The information you are asking for, such as sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, and training set details, are specific to the validation of AI/ML systems, particularly in medical imaging or diagnostic contexts. This document is about a surgical suture.

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