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The CODMAN ETHISORB™ Dura Patch is a synthetic, absorbable implant intended for bridging defects of the dura mater.
The CODMAN ETHISORB™ Dura Patch is an absorbable, synthetic implant for bridging defects of the dura mater.

The CODMAN ETHISORB™ Dura Patch is composed of a composite fleece fabric of polyglactin 910 and polydioxanone yams, with a polydioxanone film dyed with D&C Violet No. 2 on one surface. The porous structure of the fleece allows tissue on-growth while the PDS film coating minimizes leakage of cerebrospinal fluid (CSF). The device is provided sterile and ready for implantation in a foil pouch. Animal and clinical trials have demonstrated that the device is suitable for its intended use. The implant material is fully biocompatible and absorbable over time

The provided document is a 510(k) summary for the CODMAN ETHISORB™ Dura Patch. It describes the device, its intended use, and a summary of testing performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information for a medical device AI, CADe, or CADx system.

The "Device Testing Summary" section indicates:

• Biocompatibility Testing: "additional tests were performed on final Dura Patch product, including pyrogenicity, cytotoxicity, and implant studies of tissue reaction."
• Performance Testing: "Performance testing was conducted in the target tissue to confirm device suitability for its intended use as a dura substitute."
• Clinical Evaluation: "A prospective non-randomized clinical trial was conducted to demonstrate the clinical performance characteristics of the device. Results of all testing demonstrate that the ETHISORB™ Dura Patch is equivalent to currently marketed products in its performance as a safe and effective dura substitute."

Given the information provided in the document, it is not possible to complete the requested table and details because:

• Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC, non-inferiority margins) or their corresponding performance metrics are listed. The document generically states that "Results of all testing demonstrate that the ETHISORB™ Dura Patch is equivalent to currently marketed products in its performance as a safe and effective dura substitute." This is a qualitative statement, not a numerical performance metric against a defined criterion.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document mentions a "prospective non-randomized clinical trial" but provides no details on its methodology, sample size, data provenance, ground truth establishment, or any role of experts or AI. This device is a physical implant, not an AI/CADe/CADx system, so many of the requested fields (like AI performance, training set, experts for ground truth) are not applicable.

Conclusion: The provided 510(k) summary for the CODMAN ETHISORB™ Dura Patch does not contain the detailed, quantitative information typically found in submissions for AI/CADe/CADx devices regarding acceptance criteria and study results. Therefore, I cannot populate the requested table and answer the specific questions directly from the given text.

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