(108 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 cellulosebased 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.
This document describes the 510(k) summary for the DuraGen® Secure Dural Regeneration Matrix. It focuses on demonstrating substantial equivalence to a predicate device, DuraGen XS, rather than providing a detailed study proving the device meets acceptance criteria in the way one might for an AI/ML device (e.g., sensitivity, specificity, AUC).
Instead, the study demonstrates substantial equivalence through a comparison of physical properties, material composition, and biological performance in animal studies. The acceptance criteria here are implicitly demonstrating "similarity" or "no significant difference" in key performance characteristics, with the added benefit of improved migration resistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Characteristic/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Composition | Bovine Type I Collagen (similar to predicate) | Bovine Type I Collagen and Plant-Derived Hydroxypropyl Methylcellulose (HPMC) |
| Mechanical Properties | Similar to predicate (DuraGen XS) | Similar (Suture Retention and Tensile Strength) |
| Thickness | Similar to predicate (DuraGen XS) | Similar |
| Porosity | Similar to predicate (DuraGen XS) | Similar |
| Transition Temperature | Similar to predicate (DuraGen XS) | Similar |
| Wetting Time | Similar to predicate (DuraGen XS) | Similar |
| Resistance to Migration | Meets Slip and Submersion Tests Criteria (improved over predicate) | Meets Slip and Submersion Tests Criteria (DuraGen XS does not) |
| In Vivo Performance (Canine Duraplasty Study) | Minimal inflammation, vascularization, foreign body response, resorption by 180 days, integration by 90 days, no CSF leak, infection, or hydrocephalus (similar to predicate) | Minimal inflammation, vascularization, foreign body response; Mostly resorbed by 90-days, completely resorbed by 180-days; Completely integrated by 90-days; No evidence of CSF leak, infection, or hydrocephalus |
| Biocompatibility (ISO 10993) | Non-systemic toxicity, non-irritating, non-mutagenic, non-cytotoxic, non-hemolytic, non-pyrogenic | Demonstrated no systemic toxicity, non-irritating, non-mutagenic, non-cytotoxic, non-hemolytic |
| Endotoxin Level (LAL Test) | Less than 0.06 EU/ml (per FDA Guidance) | Less than 0.06 EU/ml |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical Testing: Not specified.
- Canine Duraplasty Study: Two animal studies were performed. The exact number of animals is not specified, but the text mentions "in vivo" and "under GLP conditions."
- Canine Efficacy Study (Migration Resistance): The exact number of animals is not specified.
- Biocompatibility Testing: Not specified.
- Data Provenance: Not specified, but animal studies were conducted "under GLP conditions," implying controlled, prospective animal studies. Country of origin not mentioned.
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 section is not applicable as the document describes a medical device (dural regeneration matrix) and its substantial equivalence to a predicate, not an AI/ML device requiring expert ground truth for interpretation of images or data. Ground truth here is established through scientific testing (mechanical, biocompatibility, animal studies).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiology reads). The studies described here are focused on physical and biological properties.
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 section is not applicable. This describes a physical medical device, not an AI/ML system, and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This concerns a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established through:
- Predicate Device Comparison: DuraGen XS, an already legally marketed device, serves as a benchmark for comparison.
- Mechanical Testing Standards: Implicit industry standards for suture retention, tensile strength, thickness, porosity, transition temperature, and wetting time.
- Specific Test Criteria: "Slip and Submersion Tests Criteria" for migration resistance.
- Histopathological & Clinical Observations in Animal Studies: For inflammation, vascularization, foreign body response, resorption, integration, CSF leak, infection, hydrocephalus.
- Biocompatibility Standards (ISO 10993): Criteria for systemic toxicity, irritation, mutagenicity, cytotoxicity, hemolysis.
- LAL Test Standards: For endotoxin levels (less than 0.06 EU/ml).
8. The sample size for the training set
This section is not applicable. This document describes a medical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable. (See point 8).
§ 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).