(15 days)
DuraGen XS™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
DuraGen XS™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects and is to be used as sutureless onlay graft. DuraGen XS™ Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with increased mass and density. DuraGen XSTM Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
This document is a 510(k) summary for the DuraGen XS™ Dural Regeneration Matrix. It does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and a study proving device performance.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. The document concludes that "Valid scientific evidence through physical property testing provides reasonable assurance that DuraGen XS™ Dural Regeneration Matrix is safe and effective under the proposed conditions of use..." This implies that physical property testing was the basis for acceptance, but the specific criteria (e.g., tensile strength, degradation rate, porosity ranges) are not provided.
- Reported Device Performance: The document states the device is "an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with increased mass and density." This describes its characteristics but doesn't provide quantitative performance metrics from a study against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided text. The document only mentions "physical property testing" without details on the studies conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not available in the provided text. The evaluation was based on physical properties, not expert-adjudicated clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided text. Adjudication methods typically apply to clinical or reader studies, which are not detailed here.
5. 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 information is not available in the provided text. This device is a medical implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not available in the provided text. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Based on the text, the "ground truth" or basis for evaluation was physical property testing to demonstrate that the device is "safe and effective under the proposed conditions of use."
8. The sample size for the training set
- This information is not available in the provided text. This is a physical medical device, and the concept of a "training set" is not applicable in the context of this 510(k) summary.
9. How the ground truth for the training set was established
- This information is not available in the provided text. As mentioned above, the concept of a "training set" doesn't apply here.
In summary:
This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (DuraGen Plus® Dural Regeneration Matrix K032693) primarily through physical property testing, rather than detailed clinical study data with specific acceptance criteria and performance metrics. The document does not provide the level of detail requested for a comprehensive study description.
§ 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).