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510(k) Data Aggregation
(416 days)
NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix. NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.
The provided document is a 510(k) Summary for the NeuraGen® 3D Nerve Guide Matrix. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance study. Therefore, much of the requested information (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or not detailed in this regulatory document.
However, the document does describe the testing performed to demonstrate substantial equivalence, which serves as the "study that proves the device meets (implicit) acceptance criteria" for regulatory clearance.
Here's an attempt to answer your questions based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices through rigorous testing, primarily bench tests and biocompatibility assessments, and an animal study for efficacy. The "acceptance criteria" here are essentially the 'Pass' results for each test.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Bench Tests | ||
| Conduit Inner Diameter | Within specified tolerance | Each tested conduit exhibited inner diameter within specified tolerance (Pass) |
| Inner Matrix Pore Diameter | Within specified tolerance | Average pore diameter of the inner matrix is within specified tolerance (Pass) |
| Enzyme Digestion | ≤99 AU/g | Average enzyme digestion ≤99 AU/g (Pass) |
| Residual Formaldehyde | ≤215 ug/device | Free formaldehyde residue ≤215 ug/device (Pass) |
| Biocompatibility (ISO 10993) | ||
| Cytotoxicity - Agar Diffusion | No evidence of cell lysis or toxicity | No evidence of causing cell lysis or toxicity (Grade 0) (Non-cytotoxic) |
| Sensitization Test | No evidence of delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization (Non-sensitizer) |
| Irritation Test | Mean score consistent with corresponding control | Test article mean score consistent with corresponding control mean score (Non-irritant) |
| Acute Systemic Toxicity | No mortality and no evidence of systemic toxicity | No mortality and no evidence of systemic toxicity (Non-toxic) |
| Sub-Acute Systemic Toxicity | No evidence of systemic toxicity and non-irritant | No evidence of systemic toxicity and non-irritant (Non-toxic) |
| Chronic Systemic Toxicity | No evidence of systemic toxicity and non-irritant | No evidence of systemic toxicity and non-irritant (Non-toxic) |
| Bacterial Reverse Mutation Test | Non-mutagenic to tested strains | Article extracts non-mutagenic to tested strains (Non-mutagenic) |
| Chromosomal Aberration Assay | Non-mutagenic | Extract equivocal (Equivocal results) |
| Mouse Micronucleus Assay | Non-mutagenic | Article in assay non-mutagenic (Non-mutagenic) |
| Endotoxin-mediated Pyrogenicity | < 0.06 EU/mL | Test article contained less than 0.06 EU/mL (Non-pyrogenic) |
| Material-mediated Pyrogenicity | Animal temperatures within USP limits | Animal temperatures within USP limits (Non-pyrogenic) |
| Ethylene Oxide Sterilization Residuals | Meets ISO 10993-7 requirements for all timepoints | Meets requirements of ISO 10993-7, passes each of four timepoints (24 hours, 30 days, total daily intake) (Residual levels acceptable) |
| Animal Study | Demonstration of efficacy | Conducted to study the efficacy of the product in a clinically relevant, critical sized nerve defect model in a rat. (Implied successful demonstration of efficacy to support substantial equivalence). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for bench tests. For the animal study, the document mentions "a clinically relevant, critical sized nerve defect model in a rat," but does not specify the number of rats or the design of the study (e.g., number of treatment arms, controls).
- Data Provenance: Not specified, but likely from testing conducted by or for Integra LifeSciences Corporation in a laboratory setting. No information on country of origin or retrospective/prospective nature is given beyond being a "study." Given it's an animal study, it would be prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device for physical repair, not an AI/diagnostic device that relies on expert interpretation for ground truth. The "ground truth" for these tests are objective measurements (e.g., diameter, chemical concentration) and biological responses (e.g., cell viability, animal health markers).
4. Adjudication method for the test set
Not applicable, as the tests are primarily objective measurements or standard biological assays rather than subjective interpretations requiring adjudication.
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 device is a physical nerve guide matrix, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The "ground truth" for the various tests includes:
- Bench Tests: Objective physical measurements (e.g., inner diameter, pore diameter), chemical analyses (e.g., enzyme digestion, formaldehyde residue), and material properties.
- Biocompatibility Tests: Standard biological assays with established endpoints (e.g., cell lysis, dermal sensitization, systemic toxicity, mutagenicity, pyrogenicity) as defined by ISO 10993 and other relevant standards.
- Animal Study: Implied physiological outcomes and nerve regeneration specific to the "clinically relevant, critical sized nerve defect model in a rat."
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models that require training sets.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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