(28 days)
The NeuraGen® 3D Nerve Guide Matrix 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.
This document is a 510(k) premarket notification for a medical device called the "NeuraGen® 3D Nerve Guide Matrix." It focuses on demonstrating substantial equivalence to a previously marketed predicate device and does not involve AI/ML performance testing. Therefore, many of the requested elements for AI/ML device studies are not applicable.
Here's an analysis based on the provided text, highlighting which sections are not relevant to this type of submission:
1. A table of acceptance criteria and the reported device performance
Not applicable in the context of an AI/ML device's performance through a diagnostic or predictive study. This submission is for a physical medical device (nerve guide matrix) and its performance is evaluated through material properties, biological safety, and equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML study involving a test set of data. The "test" mentioned is a viral inactivation study of the device material.
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)
Not applicable. No ground truth establishment by experts for a test set of data is described. The viral inactivation study uses laboratory measurements and established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context is the efficacy of the viral inactivation process, measured by accepted scientific methods in a laboratory setting.
8. The sample size for the training set
Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable.
Information Relevant to the K163457 Submission of the NeuraGen® 3D Nerve Guide Matrix:
The submission focuses on demonstrating substantial equivalence to a predicate device (K130557) and ensuring the safety of the device material.
Acceptance Criteria and Reported Performance (from the document):
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Same design, material, and chemical composition as predicate device (K130557). Same manufacturing and processing. | The NeuraGen® 3D Nerve Guide Matrix has the same design, material, and chemical composition, and manufacturing/processing as the predicate device (K130557). |
| Biological Safety (Viral Inactivation) | Conformance to ISO 22442-3 (Validation of the elimination and/or inactivation of viruses and TSE agents) and FDA Recognition Number 15-47. | Viral inactivation study resulted in a six log reduction of the viral titers through combined enzymatic and alkali treatment processes. |
Study Details Related to the Viral Inactivation Test:
- Sample Size Used for Test Set: The document mentions "a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products." This implies a representative sample of the material was used for the viral inactivation study. The exact number of samples for the study is not specified in the provided text.
- Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by the manufacturer or a contract research organization.
- Ground Truth Establishment: The "ground truth" for viral inactivation is established by internationally recognized standards (ISO 22442-3) and regulatory guidance, using established laboratory methods to measure viral titers before and after processing.
- Qualifications of Experts: Not specified, but personnel conducting such studies would be trained in virology and laboratory safety protocols.
Conclusion stated in the document:
The NeuraGen® 3D Nerve Guide Matrix is substantially equivalent to the current marketed device (NeuraGen® 3D Nerve Guide Matrix, K130557). The viral inactivation study's results do not change the intended use or fundamental scientific technology of the device and do not raise new issues of safety or effectiveness.
§ 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).