(66 days)
NeuroGen™ Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
NeuroGen" Nerve Guide is an implant designed for repair of peripheral nerve discontinuities. NeuroGen™ Nerve Guide provides a protective environment for peripheral nerve repair after injury. NeuroGen" Nerve Guide is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap.
NeuroGen" Nerve Guide is flexible to accommodate movement of joint and associated tendons while retaining its shape and is resistant to occlusive forces from surrounding tissue. When hydrated, NeuroGen" is an easy to handle, soft, pliable, nonfriable, porous collagen tube. NeuroGen™ Nerve Guides are provided sterile in double blister packages in a variety of sizes.
The NeuroGen™ Nerve Guide is a device for repairing peripheral nerve discontinuities. The provided documents focus on its substantial equivalence to predicate devices based on safety and performance in animal studies, rather than defining specific statistical acceptance criteria for its effectiveness in humans. Therefore, it's not possible to generate a table of acceptance criteria and reported device performance in the typical sense of a human clinical trial with defined metrics like sensitivity or specificity.
However, based on the provided text, we can describe the studies conducted to demonstrate its safety and performance:
1. Table of Acceptance Criteria and Reported Device Performance
As specific statistical acceptance criteria for human device performance (e.g., success rate of nerve repair) and corresponding reported performance are not present in this 510(k) summary, this section will describe the types of criteria the device aimed to meet through its testing and the general outcomes reported.
| Acceptance Criterion Type (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | - Noncytotoxic |
- Nonpyrogenic
- Nonirritating
- Nonsensitizing
- Acute Systemic Toxicity (no toxicity)
- Subchronic Toxicity (no toxicity)
- Chronic Toxicity (no toxicity)
- Genotoxicity (non-mutagenic)
- Implantation (biocompatible)
- Hemolysis (no hemolysis) |
| Effectiveness in Nerve Repair | Demonstrated to be substantially equivalent to nerve graft, direct suture, and silicone tubes for repairing peripheral nerve discontinuities in animal models. The studies confirmed it provides a protective environment for peripheral nerve repair and creates a conduit for axonal growth. Long-term evaluations in primates demonstrated it is biocompatible and provides an environment for axonal growth. |
| Mechanical Properties | - Suture retention: Able to hold a suture. - Mechanical compression: Resistant to repeated compression from surrounding tissues. |
| Physical Properties | - Porosity: Porous outer surface and tube wall. - Permeability: Allows the passage of molecules of specific size through the tube wall.
- Flexibility: Flexible to accommodate movement of joint and associated tendons.
- Shape Retention: Retains its shape despite movement.
- Resistance to Occlusive Forces: Resistant to occlusive forces from surrounding tissue.
- Handling: When hydrated, easy to handle, soft, pliable, nonfriable. |
| Substantial Equivalence | NeuroGen™ Nerve Guide is substantially equivalent in function and intended use to Salumedica™ Nerve Cuff, NeuroTube®, and Fastube™ Nerve Cuff. It is a tubular device, provided sterile, for single use, and manufactured from a bioresorbable material (like NeuroTube®). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Animal Studies: Not explicitly stated for specific numbers of animals, but refers to "a long-term (3.5 years) primate study and in rodent animal models."
- Biocompatibility/Mechanical/Physical Tests: Not specified in terms of sample size (e.g., number of guides tested), but mentions "a series of tests."
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-clinical animal and laboratory tests rather than human clinical data. They are retrospective or prospective in the sense of being conducted as part of the device's development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The ground truth for effectiveness was established in animal models, likely through histological analysis, functional recovery assessment, and comparison to established nerve repair methods. The ground truth for biocompatibility, mechanical, and physical properties was established through standardized laboratory testing.
4. Adjudication Method for the Test Set
This information is not provided, as the studies are primarily animal and laboratory-based. Adjudication methods are typically relevant for human clinical trials or expert-based assessments of medical imaging.
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
No MRMC comparative effectiveness study was done. This device is a physical implant, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Effectiveness (Nerve Repair):
- Animal model outcomes (e.g., histological evidence of axonal growth, functional recovery, comparison to established repair methods like nerve graft, direct suture, and silicone tubes).
- Biocompatibility: In vitro and in vivo toxicological assessments (e.g., cell viability, pyrogenicity tests, irritation assays, systemic toxicity endpoints, implantation site reactions).
- Mechanical and Physical Properties: Laboratory measurements using established test methods for suture retention, compression resistance, porosity, and permeability.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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).