(28 days)
DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.
The provided text describes a 510(k) premarket notification for the DuraGen® Secure Dural Regeneration Matrix. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel functionality. Therefore, the requested information elements related to performance metrics, statistical studies, expert adjudication, and training/test set details are not applicable in the context of this regulatory document.
However, I can extract the relevant information concerning the device, its intended use, and the single test result mentioned:
Device & Indications for Use:
- Device Name: DuraGen® Secure Dural Regeneration Matrix
- Indications for Use: Indicated as a dura substitute for the repair of dura mater.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Inactivation | Six log reduction of viral titers demonstrated through a viral inactivation study conforming to ISO 22442-3. |
Study Details:
- Sample size used for the test set and data provenance: Not applicable. The "test set" in this context refers to the samples used in the viral inactivation study. The document states "These processes were performed in a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products," but does not specify the sample size for this specific study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a laboratory study assessing viral inactivation, not an expert-driven performance evaluation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the viral inactivation study was the measured reduction in viral titers following the specified treatment processes, evaluated against the standards of ISO 22442-3.
- The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm or a training set in that context.
- How the ground truth for the training set was established: Not applicable.
§ 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).