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Meso Bilayer Surgical Mesh is intended for implantation to reinforce soft tissues where weakness exists in patients requiring soft tissue repair and reinforcement in plastic and reconstructive surgery including but not limited to the following procedures: reinforcement of primary closure such as suture line reinforcement and muscle flap reinforcement; hernia repair (e.g. hiatal, femoral, paracolostomy, umbilical.) Meso Bilayer Surgical Mesh is supplied sterile and for one time use.

Meso Bilayer Surgical Mesh is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine tissue and a synthetic absorbable polymer. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

The provided text describes the regulatory submission for the "Meso Bilayer Surgical Mesh" and its comparison to a predicate device. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI device or a device with a human-in-the-loop component.

This document is a 510(k) summary for a surgical mesh, which is a medical device for tissue reinforcement. The studies mentioned (biocompatibility, biomechanical bench testing, characterization testing, and in vivo performance testing) are for evaluating the physical and biological properties of the mesh itself, showing its equivalence to a predicate device. They are not studies related to diagnostic accuracy, AI performance, or human reader effectiveness.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met for an AI device. The document is about a different type of medical device.

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