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CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

CosMatrix is a remodelable collagen matrix derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

The provided text is a 510(k) Premarket Notification for the CosMatrix device, which is a surgical mesh. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study.

Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth establishment are not applicable to this document as it describes a substantial equivalence submission, not a performance study that measures specific metrics against predefined acceptance criteria.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The 510(k) submission seeks to establish substantial equivalence to predicate devices, not to meet pre-defined performance acceptance criteria with specific metrics. The "performance" described is in terms of biocompatibility and design characteristics being similar to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document does not describe a clinical performance study with a test set. It describes a biocompatibility assessment and comparison to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a test set is described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable. As no test set performance is being evaluated against ground truth, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is irrelevant and not described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The concept of "ground truth" as it pertains to assessing the accuracy of a diagnostic or predictive device is not relevant to this submission for a surgical mesh. The "truth" being established is that the device is safe and effective via substantial equivalence to existing devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Summary of Relevant Information from the Document:

While the document doesn't fit the requested structure for AI/diagnostic device performance studies, here's what it does provide:

• Device Information: CosMatrix is a remodelable collagen matrix derived from bovine skin for reinforcing soft tissues in plastic and reconstructive surgery.
• Intended Use: Implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
• Equivalence Claim: Substantially equivalent in function and intended use to:
  • TissueMend (TEI Biosciences, K020455)
  • Permacol (Tissue Science Laboratories, K013625)
  • SIS Plastic Surgery Matrix (Cook Biotech, K034039)
• Biocompatibility Assessment: A rigorous assessment was performed by an independent certified laboratory.
  • Tests Performed: Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, intramuscular toxicity, hemolysis, and pyrogenicity.
  • Result: Demonstrated biocompatibility.
• Manufacturing Methods: Tested by an independent laboratory to assure safe levels of viral inactivation.

This 510(k) application focuses on showing that CosMatrix shares similar technological characteristics (design, material origin - bovine, remodelable nature) and has an equivalent safety profile (biocompatibility, viral inactivation) to other legally marketed predicate devices, thereby establishing "substantial equivalence" as required by the FDA's 510(k) pathway. It does not involve performance criteria and studies typical for AI-enabled devices or diagnostic tools.

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