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SmartStitch Suture Device:

The Opus SmartStitch M-Connector (Model #OM-8005) is indicated for use with a Actuation Handle (Model #OM-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

SmartStitch Sutures:

The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

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The provided documentation is a 510(k) summary for the Opus SmartStitch® Suture Device. This type of document is intended to demonstrate substantial equivalence to a predicate device and therefore does not typically contain information about specific performance acceptance criteria or detailed study results of the kind requested for AI/ML-driven devices.

The document discusses the regulatory classification, indications for use, and a general statement of substantial equivalence. It does not include the type of detailed study information (acceptance criteria, sample sizes, expert qualifications, ground truth establishment, MRMC studies, standalone performance, or training data details) that would be present for a modern AI/ML device approval.

Therefore, I cannot extract the requested information from the provided text. The document itself is a regulatory clearance letter, not a performance study report.

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