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Force Fiber® Black Co-Braid 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® Black Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 5-0 through 5, meeting USP requirements except for oversized diameter.

The provided document is a 510(k) summary for a surgical suture and does not describe acceptance criteria, performance studies, or ground truth establishment for an AI/ML powered medical device. Therefore, I cannot extract the requested information from this document.

The document pertains to a physical medical device (suture) and discusses its substantial equivalence based on:

1. Detailed device description: Composition (UHMWPE for Force Fiber Black Co-Braid Polyethylene), availability in sizes 5-0 through 5, and meeting USP requirements except for oversized diameter.
2. Performance testing: All sizes tested according to USP 30 for Knot Pull Tensile Strength, Needle Attachment, and Diameter, meeting the Class II Special Controls Guidance for Surgical Sutures (June 3, 2003).
3. Conformance with voluntary performance standards: ISO 10993-1:2003 for biological qualification safety tests of materials.

The review of the provided text confirms that it is a 510(k) submission for a non-AI/ML surgical suture. Therefore, the requested information regarding AI/ML device acceptance criteria, study details, and ground truth establishment is not present.

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