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Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.

The provided document is a 510(k) Pre-Market Notification for a surgical suture, not a submission for an AI/ML powered device. As such, it does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods typically associated with studies for AI/ML devices. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing in accordance with regulatory standards for surgical sutures.

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