(90 days)
Reinforced Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue).
Reinforced Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular matrix circumferentially supported with a resorbable synthetic polymer filament. The device provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. The synthetic polymer filament provides enhanced support for biomechanical stability and kink-resistance of the collagen conduit. The Reinforced Flexible Collagen Nerve Cuff is an interface between the nerve and the surrounding tissue to prevent ingrowth of scar tissue. When implanted at a severed peripheral nerve gap, the Reinforced Flexible Collagen Nerve Cuff provides guidance for axonal growth across the gap. Upon hydration, the Reinforced Flexible Collagen Nerve Cuff is a soft, flexible collagen conduit with compression-resistant and kink-resistant properties. It is supplied sterile, nonpyrogenic, in various sizes and for single use only.
The provided text describes a 510(k) premarket notification for a medical device called "Reinforced Flexible Collagen Nerve Cuff." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested sections related to acceptance criteria, MRMC studies, standalone performance, and ground truth establishment for AI/ML models cannot be extracted or inferred from this document. This document details the regulatory approval process for a biomedical device based on non-clinical and animal studies, not an AI/ML algorithm.
However, I can extract information related to the device's performance based on the comparison to the predicate device in the provided non-clinical and animal studies.
Here's the information that can be extracted, and an explanation of why other requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in terms of precise numerical thresholds for clinical performance (e.g., sensitivity, specificity) as would be the case for an AI/ML medical device. Instead, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device through various non-clinical and animal studies, showing comparable safety and performance characteristics.
The "performance" is reported as being "comparable" to the predicate device or passing standard biological tests.
| Parameter/Test | Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|---|
| Physical Characterization | Must be comparable to predicate device. | Test results of the finished subject device are comparable to the predicate device for suture pullout, compression resistance, kink resistance, permeability, and hydrothermal transition temperature. |
| Animal Performance | Must demonstrate robust nerve regeneration comparable to predicate device and autograft. | Nerve regeneration was robust for both the subject and predicate devices. |
| Cytotoxicity | Non-cytotoxic (no cell lysis or toxicity). | Non-cytotoxic; No evidence of causing any cell lysis or toxicity. Test article scored '0' (non-cytotoxic). |
| Sensitization | No evidence of delayed dermal contact sensitization. | No evidence of causing delayed dermal contact sensitization in the guinea pig. Test article not considered a sensitizer. |
| Intracutaneous Reactivity | No irritation or toxicity. | No irritation or toxicity from the extract injected intracutaneously. |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity. | No mortality or evidence of systemic toxicity up to 72 hours. |
| Subchronic Toxicity | No evidence of systemic toxicity or adverse findings. | No evidence of systemic toxicity or adverse findings specifically attributed to the test article up to 13 weeks. |
| Genotoxicity | Non-mutagenic/non-genotoxic. | Non-mutagenic to tested bacterial strains. Considered non-mutagenic (non-genotoxic and non-clastogenic). |
| Material-Mediated Pyrogenicity | Non-pyrogenic (temperature rise |
§ 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).