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Stryker Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.

Stryker Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/blue coloration patterns. Stryker Suture Tape complies with USP standards for #2 suture with the exception of size classifications. Each Suture Tape variation will be cut to length and provided to the end user in a single-use sterile barrier system (SBS).

The provided document is a 510(k) Premarket Notification from the FDA regarding the Stryker Suture Tape. It does not contain information about acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-driven medical device, as the request implies. Instead, it describes a traditional medical device (surgical suture) and its substantial equivalence to predicate devices based on non-clinical benchtop testing.

Therefore, I cannot fulfill the request as it asks for information (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set details) that is not relevant to this type of device submission.

The document explicitly states: "Non-clinical benchtop testing was performed to verify that Stryker Suture Tapes exceed the minimum requirements of USP standards for knot pull tensile strength of nonabsorbable surgical sutures. Clinical testing was not required to demonstrate substantial equivalence for this submission."

It is important to note that this device is a physical surgical suture, not a software or AI-based device, hence the absence of the requested AI-specific information.

If you would like me to summarize the performance data and equivalence claims made for the Stryker Suture Tape based on the provided document, I can do so.

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