(86 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (e.g., Specific burst strength in psi, specific tensile strength in N) | "No significant difference between the test and control articles" for burst strength, suture retention, ultimate tensile, and shrink temperature testing. |
| Not specified (e.g., Specific biocompatibility endpoints) | "No significant difference between the test and control articles" for biocompatibility testing. |
Study Details (Information Not Available in the Provided Text)
- Sample size used for the test set and the data provenance: Not specified.
- 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.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
- 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.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- 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.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).