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SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Plastic and reconstructive surgery Muscle flap reinforcement Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias

SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

This document is a 510(k) Premarket Notification for a medical device called SurgiMend Collagen Matrix for Soft Tissue Reconstruction. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.

The document primarily states:

• Device Description: SurgiMend is an acellular dermal tissue matrix derived from bovine dermis for soft tissue reinforcement and repair.
• Intended Use: Plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair.
• Predicate Devices: SurgiMend (K071807) and TissueMend (K020488) from TEI Biosciences.
• Technological Characteristics: Substantially equivalent to other surgical meshes.
• Biocompatibility: A rigorous assessment by an independent laboratory demonstrated biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular implantation, hemolysis, and pyrogenicity). Viral inactivation methods were also tested.

Essentially, this submission asserts that the new SurgiMend device is safe and effective because it is fundamentally the same as devices already on the market, which presumably had their safety and effectiveness established through other means (e.g., prior clinical data for older predicate devices, or through general knowledge of the safety of collagen matrix materials). There is no "study that proves the device meets the acceptance criteria" in the format of specific performance metrics against pre-defined thresholds.

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