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SeriScaffold™ surgical mesh 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.

SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.

The provided text is a 510(k) summary for a medical device called "SeriScaffold™ surgical mesh." It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing, biocompatibility testing, and an in vivo rabbit study.

However, the provided document does not contain the specific type of information requested regarding acceptance criteria, reported device performance in those terms, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies.

The document instead focuses on demonstrating substantial equivalence through:

• Bench testing: "Results from performance testing based on 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh', March 2, 1999 demonstrates substantial equivalence of SeriScaffold surgical mesh to predicate surgical mesh products." These likely cover properties like tensile strength, suture retention, and tear resistance, which are typical for surgical mesh.
• In vitro bioresorption study: "Results from an in vitro bioresorption study characterize the bioresorption properties of SeriScaffold surgical mesh versus Vicryl Mesh which support the long-term bioresorption property of SeriScaffold surgical mesh."
• Biocompatibility testing: "Biocompatibility was conducted according to internationally recognized standards and all results indicate the device is biocompatible."
• In vivo rabbit study: "Data from an in vivo rabbit study further support the bioresorption and biocompatibility properties of the device."

Since the request is specific to an AI/ML device evaluation structure (e.g., acceptance criteria for a diagnostic performance, MRMC study effect sizes), and this document is for a physical surgical mesh, the requested information categories are not directly applicable or present in the provided text.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device evaluation as the document describes a traditional medical device submission (surgical mesh) that does not involve artificial intelligence, machine learning, or diagnostic performance metrics with human readers.

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