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510(k) Data Aggregation
(137 days)
The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.
The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate Nerve Cuff (K031069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in clamshell container inside a sealed double pouch system.
The document describes the acceptance criteria and study results for the Cook Biotech Incorporated Nerve Cuff (K132660). The submission focuses on demonstrating substantial equivalence to a predicate device (Surgisis Nerve Cuff, K031069) through bench, biocompatibility, and animal studies.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative "acceptance criteria" for each test in the way you might find in an AI/software device submission. Instead, it demonstrates performance by showing that the Nerve Cuff is "substantially equivalent" to its predicate device or meets specific qualitative standards.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Ultimate tensile strength | Comparable to predicate (Surgisis Nerve Cuff) | "The tensile strength was comparable to Surgisis Nerve Cuff predicate." "the Nerve Cuff has sufficient tensile... strength for its application." |
| Suture retention strength | Comparable to predicate (Surgisis Nerve Cuff) | "The suture retention strength was comparable to the Surgisis Nerve Cuff." "the Nerve Cuff has sufficient... suture retention strength for its application." | |
| Compression and rebound testing | Applicable results from predicate (as material/configuration are identical) | "Compression and rebound testing was performed on the predicate Surgisis Nerve Cuff. Since the Nerve Cuff is identical in material and configuration to the Surgisis Nerve Cuff, the results are applicable to the subject device's intended use." | |
| Hydration testing | Devices within specified thickness range upon hydration | "Re-hydrated devices were compared to non-hydrated controls. Devices were within the specified thickness range upon hydration." | |
| Biocompatibility | Genotoxicity (Mouse micronucleus assay) | Non-mutagenic | "results indicate that the test article is non-mutagenic in this system." |
| Genotoxicity (Mouse lymphoma assay) | Non-mutagenic | "results show that the test article extracts were well within the limits defined for a negative response and the test article is considered non-mutagenic in this assay." | |
| Direct contact in vitro hemolysis | Non-hemolytic (Hemolytic index ≤ 5%) | "Under conditions of the study, the mean hemolytic index of the test article was 2%." | |
| Cytotoxicity | Non-cytotoxic (no evidence of cell lysis/toxicity, < Grade 2 reactivity) | "Under the conditions of the study, the test extract showed no evidence of causing cell lysis or toxicity (less than Grade 2 – mild reactivity." | |
| Muscle Implantation (irritation) | Non-irritant at 24 weeks after implantation (compared to control) | "At 4, 12, and 24 weeks after implantation, the macroscopic reaction was not significant compared to control... At 24 weeks after implantation, microscopy examination of implants sites revealed that the test article was similar to or less irritating than all the control materials." (Note: It was classified as a moderate irritant at 4 and 12 weeks, but concluded non-irritant at 24 weeks within the context of the study vs. controls). | |
| Acute Intracutaneous Reactivity | Non-irritant | "Under the conditions of the study, there was no evidence of significant irritation from the extracts injected intracutaneously into rabbits." | |
| Sensitization | Non-irritant | "Under the conditions of the study, the test article showed no evidence of causing delayed contact sensitization in the guinea pig." | |
| Acute Systemic Toxicity | No systemic toxicity | "Under the conditions of the study, there was no mortality or evidence of systemic toxicity from the extracts." | |
| Pyrogenicity | Non-pyrogenic (total rise of rabbit temps within USP limits) | "Under the conditions of the study, the total rise of rabbit temperatures during the 3 hour observation period was within acceptable USP limits." | |
| LAL endotoxins | Non-pyrogenic (<20 EU per device for blood contact) | "Under the conditions of the study, the endotoxin concentration for each article was less than 20 EU per device as required by FDA for devices in blood contact." | |
| Subchronic Systemic Toxicity | No systemic toxicity | "Data and observations revealed no significant evidence of systemic toxicity from the test article following subcutaneous implantation in the rat. There were no changes in histopathology, hematology values or clinical chemistry values in either male or female rats that would be considered indicative of systemic changes related to treatment with the test article." | |
| Animal Studies | Nerve wrap effectiveness and biocompatibility | Healthy nerve regeneration (myelination, density, vascularization) compared to sham controls; safe and effective. | "The Nerve Cuff was implanted in rabbits as a nerve wrap. The wrapped nerves were healthy in terms of myelination, density and vascularization compared to sham controls. All assessments showed that the device is safe and effective as a nerve wrap." "Therefore, results showed that the Nerve Cuff is biocompatible and safe in its application." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The sample sizes for each specific bench test (tensile strength, suture retention, hydration) are not explicitly stated in the provided text. Compression and rebound testing was done on the predicate, not the new device.
- Biocompatibility Testing: The specific sample sizes for tests like genotoxicity (number of animals or cells), hemolysis (number of samples), cytotoxicity (number of well plates/cells), muscle implantation (number of animals), intracutaneous reactivity (number of rabbits), sensitization (number of guinea pigs), acute systemic toxicity (number of animals), pyrogenicity (number of rabbits), LAL endotoxins (number of devices), and subchronic systemic toxicity (number of rats) are not explicitly detailed in the provided summary.
- Animal Studies: The Nerve Cuff was "implanted in rabbits as a nerve wrap." The number of rabbits is not specified.
- Data Provenance: The document does not specify the country of origin for any of the studies (bench, biocompatibility, or animal). All studies appear to be prospective, laboratory-based tests/experiments. This is not a clinical study involving human patients.
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)
This product is a medical implant (nerve cuff), not an AI/software device that requires human expert interpretation of imaging or other data for ground truth establishment. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications like radiologists is not applicable to this 510(k) submission. Ground truth for the studies (e.g., biocompatibility endpoints, nerve health in animals) would be established through laboratory analyses, histological examination, and macroscopic observations by scientific and veterinary professionals, respectively, but their specific number and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable as it pertains to human interpretation of data, typically in clinical studies or AI evaluations where a consensus among experts is needed. The studies conducted for this device (bench, biocompatibility, animal) rely on objective measurements and established scientific methodologies, not subjective expert adjudication of a "test set."
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
This is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. The Nerve Cuff is a physical implant, not an AI or diagnostic software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Nerve Cuff is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the studies was based on:
- Bench Testing: Objective physical measurements (tensile strength, suture retention, thickness).
- Biocompatibility Testing: Standardized laboratory assays and animal models for genotoxicity, hemolysis, cytotoxicity, irritation, sensitization, systemic toxicity, and pyrogenicity, with results typically assessed against established scientific criteria and ISO standards. Histopathology was used for muscle implantation and subchronic systemic toxicity assessments.
- Animal Studies: Macroscopic and microscopic histological assessments of nerve health (myelination, density, vascularization) compared to sham controls.
8. The sample size for the training set
This is not applicable. The Nerve Cuff is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reason stated in point 8.
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