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ACTIVBRAID™ is indicated 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.

ACTIVBRAID is a partially absorbable surgical co-braid suture constructed of nonabsorbable Ultra High Molecular Weight Polyethylene (UHMWPE) and absorbable bovine-derived type I collagen. ACTIVBRAID suture ends are stiffened with cyanoacrylate.

ACTIVBRAID is available in several sizes (sutures meet U.S. Pharmacopeia standards for nonabsorbable sutures, except diameter). Sutures are oversized in diameter. ACTIVBRAID is provided in pre-cut lengths with and without needles. Suture strands that are dyed (Chromium Cobalt-Aluminum Oxide or D&C Black No. 4) are made of UHMWPE.

The provided text is a 510(k) Summary for the ACTIVBRAID™ surgical suture. It details the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence. However, the document does not describe a study involving a medical device software with AI/ML components that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance.

The "performance data" section in the document refers to:

• Biocompatibility Testing: Evaluating the biological response of the material.
• Non-Clinical Performance Testing: Assessing physical properties of the suture (diameter, needle attachment, tensile strength) against USP standards and comparing other mechanical properties (abrasion, knot profile/security, physiological fluid absorption) to the predicate device.
• Resorption Profile: Characterizing the device's absorption rate and tensile strength retention over time in an animal model.

These are standard performance tests for physical medical devices like sutures, not for AI/ML-driven diagnostic or assistive software. Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document explicitly states: "Biocompatibility and nonclinical performance testing data demonstrate that ACTIVBRAID is as safe, as effective, and performs as well as or better than the predicate device, K112899." This indicates that the "acceptance criteria" are related to meeting or exceeding the performance of the predicate device and established standards for surgical sutures.

In summary, the provided text does not contain the information requested about AI/ML device acceptance criteria and studies.

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