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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).

Device Description

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.

AI/ML Overview

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 < 0.5°C).	Non-pyrogenic. None of the rabbits had a temperature rise ≥0.5°C.
Implantation (Local Tissue Reaction)	Acceptable local tissue reaction compared to control.	The test article result was considered acceptable at 2 weeks and 13 weeks compared to the control article.
Haemocompatibility	Non-hemolytic.	The test article was considered non-hemolytic.
Chronic Toxicity/Degradation	Acceptable local tissue reaction and resorption compared to control.	The test article result was considered acceptable at 26 weeks compared to the control article. Resorption and incorporation into new host collagen advanced at 26 weeks.
Viral Inactivation	Viral safety ensured.	Viral inactivation studies were performed to ensure the viral safety of the product.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The "test set" in this context refers to the animals studied in the performance and toxicology tests. It's not a clinical data set for AI/ML.
Sample Size:
- Animal Performance Study (Rat Sciatic Nerve): 48 rats total.
  - 16 rats treated with subject device.
  - 16 rats treated with predicate device.
  - 16 rats treated with autograft control.
- Biocompatibility/Toxicology Studies:
  - Cytotoxicity: Cells (e.g., L-929 Mouse Fibroblast Cells).
  - Sensitization: Guinea Pig.
  - Intracutaneous Reactivity: Rabbits.
  - Acute Systemic Toxicity: Mice.
  - Subchronic Toxicity: Rabbits.
  - Genotoxicity: Bacterial strains (Salmonella typhimurium, Escherichia coli) and Mouse Lymphoma.
  - Material-Mediated Pyrogenicity: Rabbits.
  - Implantation (Local Tissue Reaction): Rabbits.
  - Haemocompatibility: Not specified (in vitro blood components).
  - Chronic Toxicity/Degradation: Rabbits.
Data Provenance: The studies were conducted in a laboratory/animal setting, not from a human retrospective or prospective clinical trial. The location (country) is not specified, but it's part of a US FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. This is not an AI/ML study involving human interpretation of images or data that requires expert consensus for ground truth. The "ground truth" for these studies is established through direct measurements, biological assays, histological analyses, and observation of animal health/physiology by qualified laboratory personnel and veterinary pathologists, not human experts providing subjective assessments.

4. Adjudication Method for the Test Set

Not Applicable. Again, this is not an AI/ML study requiring adjudication of expert opinions. Results are based on objective laboratory measurements and pathological findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is designed for evaluating human reader performance, often with and without AI assistance, especially in diagnostic imaging. This document describes a medical device (nerve cuff), not an AI algorithm, and therefore, an MRMC study was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is not an AI algorithm. "Standalone performance" is a concept applicable to AI systems.

7. The Type of Ground Truth Used

The "ground truth" for the various studies includes:
- Direct Physical Measurements: Suture pullout strength, compression resistance, kink resistance, permeability, hydrothermal transition temperature.
- Biological Assays: Cytotoxicity (cell lysis/toxicity), sensitization (dermal reactions), intracutaneous reactivity (irritation/toxicity from extract), acute systemic toxicity (mortality/systemic signs), subchronic toxicity (systemic signs), genotoxicity (mutagenesis), pyrogenicity (temperature rise).
- Histological and Histomorphometrical Methods: For the animal sciatic nerve study, evaluating nerve regeneration.
- Pathology: For implantation studies (local tissue reaction, resorption) and chronic toxicity.
- Observed Outcomes: Animal health, survival, signs of adverse reactions.

8. The Sample Size for the Training Set

Not Applicable. This document describes the testing of a physical medical device. It does not involve a "training set" as would be used for an AI/ML model.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI/ML training set, this question is not relevant.

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