(90 days)
The Bridger Biomed Dura-Patch™ is intended for replacement or repair of the dura.
Dura-Patch™ Dura Substitute is a 100% ePTFE membrane, which is intended to be used as a replacement for dura tissue deficiencies.
The provided text is a 510(k) summary for the Dura-Patch™ Dura Substitute, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed studies with acceptance criteria and performance data as might be found for novel devices or software.
Therefore, many of the requested technical details regarding acceptance criteria and study methodologies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this 510(k) submission.
Here's a breakdown based on the provided information:
1. Table of acceptance criteria and the reported device performance:
This 510(k) summary does not present formal acceptance criteria or performance metrics in the way one might expect for an AI/software device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device based on comparative technological characteristics and safety & efficacy through material biocompatibility and established clinical use of ePTFE.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Dura-Patch™) |
|---|---|
| Material Composition | Composed of 100% ePTFE membrane. |
| Intended Use | Intended to be used as a replacement for dura tissue deficiencies. |
| Biocompatibility | Inert and biocompatible. Has passed USP Class VI, carcinogenicity studies, hemocompatibility studies, and others. Proven nonreactive to body fluids and tissues. |
| Physical Properties (Comparative) | Strong enough to resist tears, supple enough to provide comfort, flexible, and impermeable to CSF. Pore size of approximately 1 micron (comparable to predicate). |
| Established Clinical Safety | Over 4,000,000 long-term ePTFE devices implanted to date, over 25 years of clinical use with no known adverse reactions to the material. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This 510(k) relies on a comparison to a predicate device and the long-established safety and efficacy of ePTFE as a material. There is no mention of a specific test set or clinical study conducted on the Dura-Patch™ itself in this summary. The data provenance related to ePTFE's clinical use is global (implied by "over 25 years of clinical use" and "virtually all major tissue types"), and retrospective (historical clinical data).
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):
Not applicable. No ground truth establishment by experts for a specific test set is described. The "ground truth" for this submission is the accepted safety and efficacy of ePTFE and the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No specific test set or adjudication method is described.
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:
Not applicable. This is not an AI/software device, and no MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for this submission is:
- Historical clinical outcomes data / established safety profile for ePTFE: "over 4,000,000 long-term ePTFE devices implanted to date," "In over 25 years of clinical use, and exposure to virtually all major tissue types, there have been no known adverse reactions to the material."
- Biocompatibility testing results: "biocompatibility assays including U.S.P. Class VI, carcinogenicity studies, hemocompatibility studies, and others."
- Performance characteristics of the predicate device: The Dura-Patch™ is stated to have comparable characteristics (strong, supple, flexible, impermeable to CSF, pore size) to the predicate device, Preclude™ Dura Substitute.
8. The sample size for the training set:
Not applicable. No training set is relevant for this physical device and its 510(k) submission.
9. How the ground truth for the training set was established:
Not applicable. No training set or associated ground truth establishment process is relevant.
§ 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).