(28 days)
DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.
DuraGen Plus™ Dural Graft Matrix, is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
The provided text, a 510(k) summary for DuraGen Plus™ Dural Graft Matrix, does not contain the detailed information required to fill out the requested table and answer all questions regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study.
This document describes a medical device, DuraGen Plus™ Dural Graft Matrix, and seeks substantial equivalence to a predicate device. The assessment of this type of device typically involves physical property testing and not clinical trials or AI/human reader studies as would be the case for diagnostic or image-based AI software.
Here's how I can answer based only on the provided text, highlighting what's missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative or qualitative manner that would be filled in a table, nor does it provide specific performance metrics from a study related to those criteria. It broadly states the device is "safe and effective under the proposed conditions of use."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use..." |
2. Sample size used for the test set and the data provenance
Not applicable. The clearance is based on physical property testing, not a test set of data from patients or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not relevant for this type of device clearance.
4. Adjudication method for the test set
Not applicable.
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
No. This is a medical device (dural graft matrix), not an AI software/diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical device, not an algorithm.
7. The type of ground truth used
Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for a dural graft matrix would relate to its physical and biological properties. The document mentions "physical property testing."
8. The sample size for the training set
Not applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does communicate about the study:
- Study Type: The clearance is based on "Valid scientific evidence through physical property testing." This implies laboratory or bench-top testing of the material properties of the DuraGen Plus™ Dural Graft Matrix.
- Conclusion of Study: The testing provided "reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device [DuraGen® Dural Graft Matrix (K982180)]."
§ 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).