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SERI™ Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

SERI™ Surgical Scaffold is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra pure fibroin. The device is a mechanically strong and biocompatible bioprotein. SERI™ Surgical Scaffold is a sterile, single use only product and is supplied in a variety of sizes ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI™ Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction. SERITM Surgical Scaffold is designed to slowly bioresorb in parallel to neovascularization and native tissue ingrowth which results in eventual replacement of As bioresorption occurs, load bearing responsibility is SERI™ with native tissue. transferred to the new tissue ingrowth such that mechanical integrity is maintained at the site.

The provided document is a 510(k) summary for the Allergan SERI™ Surgical Scaffold. This document is a regulatory submission for a medical device and describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies to meet acceptance criteria, sample sizes, expert qualifications, or ground truth establishment for an AI/algorithm-based device.

Therefore, I cannot extract the requested information from the provided text as it pertains to a traditional medical device (surgical scaffold) and not an AI/algorithm-driven device that would involve such performance metrics and studies.

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