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Endoform® Reconstructive Template is intended for use as a surgical mesh to reinforce and/ or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

This document is an FDA 510(k) premarket notification decision letter for a surgical mesh device, Endoform® Reconstructive Template - Non-Absorbable. It does not describe an AI medical device or a study involving AI. Therefore, it is impossible to answer the questions about acceptance criteria and study proving an AI device meets those criteria based on the provided text.

The document discusses the substantial equivalence of the surgical mesh to a predicate device based on:

• Biocompatibility Data: Additional cytotoxicity testing, toxicological assessment, and viral inactivation assessment were performed.
• Performance Data: Biomechanical testing (uniaxial tensile strength, ball burst strength, suture retention strength) and an in-vivo study in a soft tissue reinforcement model.
• Clinical Data: No clinical data was submitted.

The provided text pertains to a physical medical device (surgical mesh) and its substantial equivalence determination, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI device, sample sizes for AI test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to the content of this document.

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