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For use as a dural substitute for the closure of dura mater during neurosurgery.

Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.

The provided text describes a 510(k) submission for a dural repair patch, Dura-Guard, and its substantial equivalence to a previously marketed device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/medical device performance study with specific metrics like accuracy, sensitivity, specificity, etc.

The document focuses on:

• Device Description: Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
• Technological Characteristics Comparison: The submission primarily compares a new version of Dura-Guard (treated with 1M NaOH) to an older version (not treated with 1M NaOH). The comparison is based on physical properties (shrink, suture, thickness), bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing.
• Conclusion: The manufacturer believes the NaOH-treated product performs similarly to the non-NaOH-treated product and poses no additional safety or effectiveness concerns.
• FDA Clearance: The FDA found the device substantially equivalent to pre-amendments devices.

Therefore, I cannot populate the requested table and sections. The information needed to address your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI model evaluation) is not present in the provided text, as this is a traditional medical device submission, not an AI/ML-based diagnostic device.

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For use as a dural substitute for the closure of dura mater during neurosurgery.

Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.

The provided text does not contain information about acceptance criteria or a study proving that the Dura-Guard device meets acceptance criteria in the manner requested by the prompt. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance acceptance criteria and a study to meet them.

Specifically, the document states:

• "Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles." This indicates that some testing was done and a comparison was made between treated and untreated samples of the device, but it does not specify quantitative acceptance criteria for these tests.
• "Biocompatibility testing also showed no significant difference between the test and control articles." Again, testing was performed, but no acceptance criteria are provided.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies for a performance study.

Here's a summary of what is available regarding testing, and an explanation of why the requested information cannot be provided based on the input:

Acceptance Criteria and Reported Device Performance

Study Details (Information Not Available in the Provided Text)

1. Sample size used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's "acceptance" is based on physical material properties and biocompatibility, not expert-adjudicated images or clinical outcomes in the way implied by "ground truth" for AI/human reader studies.
3. Adjudication method: Not applicable.
4. 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: This device is a dural repair patch, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
6. The type of ground truth used: For material properties, the "ground truth" is measured physical properties. For biocompatibility, it's the results of standard biological tests. There's no "expert consensus" or "pathology" in the context of device performance in the way described for AI/diagnostic studies.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating that the device (Dura-Guard subjected to antibiotics) is substantially equivalent to an existing predicate device (Dura-Guard not subjected to antibiotics) by showing "no significant difference" in critical performance characteristics. It doesn't detail performance against specific, predefined acceptance thresholds which is often found in performance studies for novel devices or software.

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