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Gentrix™ Surgical Matrix 2-layer and 3-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures; hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

Gentrix™ Surgical Matrix 6-layer and 8-Laver are intended for implantation to reinforce soft tissue where weakness exists in - patients requiring - gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer devices are composed of porcinederived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open foil pouches. The devices are terminally sterilized using electron beam irradiation.

The provided text is a 510(k) Premarket Notification for a medical device called "Gentrix™ Surgical Matrix." This document is a regulatory submission for a Class II medical device, primarily focusing on demonstrating substantial equivalence to existing predicate devices.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The performance data included in the document pertains to:

• Biocompatibility Testing: According to ISO-10993-1 for a permanently implanted device.
• Mechanical Testing: Including tensile strength, suture retention strength, ball burst strength, delamination strength, tear strength, and stiffness.
• Material Characterization: Including moisture content, hydration uptake, and hydrated onset temperature.

These tests aim to demonstrate that the Gentrix™ Surgical Matrix is "substantially equivalent" to predicate and reference devices and performs adequately throughout its labeled shelf life. This is typical for a 510(k) submission, where the focus is on comparing a new device to an already legally marketed one.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as there is no specific AI/ML component or associated study described in this document.

The document discusses validation of the packaging system (ANSI/AAMI/ISO 11607-1 and -2) and substantial equivalence to predicate devices based on material, manufacturing, and performance characteristics for surgical mesh, not an AI/ML system.

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