(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 |
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).