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510(k) Data Aggregation
(90 days)
Reinforced Flexible Collagen Nerve Cuff
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 |
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(30 days)
COLLAGEN NERVE CUFF
Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protective environment for peripheral nerve repair after injury and to create a conduit for axonal growth across a nerve gap.
The Collagen Nerve Cuff is a medical device intended for the repair of peripheral nerve discontinuities. The following outlines the acceptance criteria and the study that supports the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety: Device is safe for implantation. | Biocompatibility: The Collagen Nerve Cuff is biocompatible based on FDA recommended tests and meets ISO 10993 requirements for biocompatibility testing. |
| Effectiveness: Effective for bridging nerve gaps and guiding axonal growth in peripheral nerve repair procedure under the proposed conditions of use. | Literature Review (Animal Studies): Twenty years of animal studies using nerve conduits demonstrated the efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits. |
| Literature Review (Clinical Data): Existing literature demonstrated the efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits. | |
| Technical Characteristics: Device is resorbable, flexible, suturable, biocompatible, cell occlusive, and clinically manageable. | Simulated Clinical Environment Studies: Mechanical and physical characteristics were evaluated, demonstrating adequate mechanical and physical properties for peripheral nerve repair. (Biocompatibility is also covered under safety.) |
| Substantial Equivalence: The Collagen Nerve Cuff is substantially equivalent to predicate devices. | Comparison to Predicate Devices: The overall submission concludes that the device is substantially equivalent to the NeuroGen™ Nerve Guide [510(k) #K011168], SaluMedica™ Nerve Cuff [510(k) #K002098], and Fastube™ Nerve Cuff [510(k) #K850785]. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: The primary evidence supporting the device's performance for this 510(k) relies on a literature review of animal and human studies.
- Animal Data: "animal studies over the past twenty years using nerve conduit have been reviewed." The specific sample size (number of animals, number of studies) is not provided.
- Clinical Data: "The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits." The specific sample size (number of patients, number of studies) is not provided.
- Data Provenance: The document does not specify the country of origin of the data for the literature review. The studies are retrospective, as they involve the review of existing published literature.
- Simulated Clinical Environment Studies: These were performed to evaluate mechanical and physical characteristics. No specific sample size (e.g., number of cuffs tested) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the literature reviews (animal and clinical data), the "ground truth" implicitly comes from the findings and conclusions of the researchers who conducted those original studies. The 510(k) summary itself does not detail how many experts retrospectively reviewed and established the ground truth from the existing literature, nor does it specify their qualifications.
- For the simulated clinical environment studies, the "ground truth" is based on objective measurements of mechanical and physical properties. This typically involves technical experts in materials science or biomedical engineering, but their number and qualifications are not specified in this document.
4. Adjudication Method for the Test Set
- Given that the primary evidence comes from a literature review and simulated clinical studies rather than a prospective clinical trial with a defined test set of patients, a formal adjudication method (e.g., 2+1, 3+1) for clinician review of patient outcomes is not applicable or described in this 510(k) summary. The summary relies on the conclusions drawn by the authors of the original studies in the literature and the results from the simulated clinical environment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done for this device submission. The submission relies on a review of existing literature and simulated clinical testing, not a study comparing human readers with and without AI assistance. The device is a physical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant (nerve cuff), not a software algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Literature Review (Animal and Clinical): The ground truth for effectiveness is derived from the published results and conclusions of scientific studies in the literature on nerve repair using conduits. This would include histological observations, functional recovery assessments, and potentially patient outcomes reported in those studies.
- Biocompatibility: Ground truth is established through standardized biocompatibility testing (e.g., ISO 10993) where specific biological responses are measured against predefined acceptable limits.
- Simulated Clinical Environment: Ground truth for technical characteristics is based on objective measurements of physical and mechanical properties (e.g., tensile strength, flexibility, permeability) against design specifications deemed adequate for the intended use.
8. The Sample Size for the Training Set
- Not applicable. This device submission does not involve a machine learning algorithm that requires a "training set." The evidence for the device's safety and effectiveness comes from a review of existing scientific literature, biocompatibility testing, and simulated clinical environment studies.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for a machine learning algorithm, the establishment of ground truth for such a set is not relevant to this submission.
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