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The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

The CorMatrix Pericardial Patch is manufactured from porcine small intestinal i he Conviatiix refleardial is manufactures are a seets with varying dimensions.

The provided text is a 510(k) summary for the CorMatrix Pericardial Patch. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a clinical trial for a novel therapy might.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Intended Use: The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.
• Predicate Devices:
  • Cook Biotech, Inc., SurgiSIS (K980431)
  • TEI Biosciences, Inc., TISSUEMEND (K020455)
  • W.L. Gore & Associates, Inc., Preclude Pericardial Membrane (K012098)
  • PM Devices, Inc., Peripatch Sheet (K031948)
• Substantial Equivalence: The claim is that the device's proposed indications for use and technological characteristics are substantially equivalent to the predicate devices, and that any differences do not raise new issues of safety or efficacy.
• Testing in Support of Substantial Equivalence Determination: The only mention of testing is that "the biological material in the CorMatrix Pericardial Patch was evaluated through extensive biocompatibility and animal testing." No specific performance metrics or clinical study results are detailed.

In summary, this 510(k) document does not report on a study designed to meet specific acceptance criteria with performance metrics as typically found in evaluations of AI/ML-based devices or complex diagnostic tools. It's a regulatory submission demonstrating equivalence for a Class II medical device, primarily based on its similarity to existing, legally marketed products.

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