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CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.

CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers. The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs.

The provided text describes a 510(k) premarket notification for a medical device called CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials as an AI/ML medical device would typically require.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm evaluation. Specifically, there is no mention of:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A "study that proves the device meets the acceptance criteria" in the context of AI/ML, such as a test set evaluation.
• Sample sizes for test sets or training sets, data provenance, ground truth establishment methods (expert consensus, pathology, outcomes data), number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies.

The "Performance Data" section (Section VII) details various non-clinical tests performed to support substantial equivalence, including:

• Sterilization validation/re-qualification
• EO/ECH residuals per ISO 10993-7
• Packaging validation and shelf-life per ISO 11607-1 and ISO 11607-2
• Device Characterization Testing (Dimensional verification, Tensile Strength, Tensile Stiffness/Elastic Modulus, Burst Strength, Suture Pullout Strength, Cellular Infiltration, Porosity, Collagen Denaturation)
• Design Validations (Usability Validation)
• GLP Study in an Ovine Model (animal study evaluating performance and safety compared to a predicate device)

In summary, the provided document does not contain the information relevant to the performance evaluation of an AI/ML-based medical device as detailed in your request. It pertains to a Class II medical device (a collagen matrix) that uses a 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices through non-clinical performance data and an animal study, not AI/ML algorithm performance.

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