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510(k) Data Aggregation
(500 days)
Indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Cova™ORTHO-NERVE is a pure collagen membrane designed to be used as a barrier to allow guided healing along distinct anatomical planes. It is completely resorbable within a time frame that is compatible with healing. The membrane is obtained by standardized, controlled manufacturing processes. Cova™ORTHO-NERVE is further sterilized in double-pouches by gamma-irradiation. Cova™ORTHO-NERVE membranes are designed to be resorbable, non inflammatory and biocompatible for uses to treat peripheral nerve injuries. When wetted, the membrane is conformable, elastic and easy to handle. It can be used alone or, if needed, it can be sutured in place. Cova™ORTHO-NERVE is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm, 30 x 40 mm and 40 x 60 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the zone to be treated.
This document describes a 510(k) premarket notification for the Cova™ORTHO-NERVE, a resorbable collagen membrane for peripheral nerve repair. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, a table of acceptance criteria and reported device performance from a clinical study is not applicable in this context. The information provided relates to non-clinical data, bench tests, and animal studies to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence to predicate devices, specific acceptance criteria for a novel device performance claim (e.g., a specific sensitivity/specificity for an AI algorithm) are not presented in the document. Instead, the "acceptance criteria" are implied by meeting the standards for biocompatibility, physical characteristics, and safety established by the predicate devices and relevant ISO standards.
| Test Category | Acceptance Criteria (Implied by Predicate Equivalence & ISO) | Reported Device Performance (Cova™ORTHO-NERVE) |
|---|---|---|
| Biocompatibility | No cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolytic activity, mutagenicity, or clastogenicity. Absorption within a compatible timeframe. | Non-cytotoxic, No evidence of sensitization, No evidence of irritation, No mortality or systemic toxicity, No material-mediated pyrogenicity, No hemolytic activity, No evidence of mutagenicity, No evidence of clastogenicity. Absorption by 13 weeks. No inflammation observed. |
| Implantation/Performance | Protection during nerve repair, no adverse tissue reaction, no fibrous peri-nervous tissue, no systemic toxicity. | Protection during nerve repair. No fibrous peri-nervous tissue observed after 3, 60, or 90 days. No adverse tissue reaction to the implant up to 13 weeks of implantation. No systemic toxicity. |
| Viral Inactivation | Reduction of final viral load to the limit of detection. | Demonstrated "that the inactivation steps reduced down the final viral load to the limit of detection." |
| Bench Tests | Meet similar specifications as predicate devices (e.g., color, odor, feel, dimensions, suture strength, tensile strength, pH, UV spectra purity, enzymatic degradation, swelling rate, compression, kinking, endotoxin limit). | "The following tests were performed and were found to meet the similar specifications as a predicate." (Specific values not provided, but deemed acceptable) |
| Animal Study (Performance & Safety) | Ability to confer a protective environment for the repaired nerve, no fibrous peri-nervous tissue, lowered time for re-intervention. | Demonstrated "its ability to confer a protective environment for the repaired nerve." "No fibrous peri-nervous tissue was observed after 3, 60 or 90 days." "Time for re-intervention was also lowered." |
2. Sample Sizes Used for Test Set and Data Provenance
- Biocompatibility Tests: The document does not explicitly state the sample sizes for each specific biocompatibility test (e.g., how many guinea pigs for sensitization, how many mice for systemic toxicity, how many rabbits for pyrogenicity). It only indicates the types of animals used for some tests.
- Implantation/Absorption Study: Rats were used. The number of rats is not specified, but time points were 3 weeks, 30 days, and 90 days.
- Implantation (Safety and Performance) Study: Rats were used. The number of rats is not specified, but time points were 3, 30, and 90 days.
- Subchronic/Chronic Toxicity Study: Rats were used for a 13-week study. The number of rats is not specified.
- Animal Study (Performance in nerve repair): A "rat model" was used. The specific number of rats or nerves involved is not provided.
- Data Provenance: All studies (biocompatibility, implantation, animal study) appear to be preclinical (animal and in vitro) and were conducted by the manufacturer or contracted labs. The document does not specify the country of origin for the data beyond the manufacturer being in France. These are prospective non-clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes a medical device (collagen membrane) and not an AI/imaging device requiring expert-established ground truth for a test set in the conventional sense. The "ground truth" for the non-clinical studies is determined by direct measurement, observation, and histological analysis by researchers/pathologists.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the document is for a physical medical implant, not an AI or imaging diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the document is for a physical medical implant, not an AI or imaging diagnostic device. There is no "algorithm" in the context of Cova™ORTHO-NERVE.
7. Type of Ground Truth Used
The "ground truth" for the studies described relies on:
- Biochemical/Cellular Assays: For cytotoxicity, sensitization, pyrogenicity, hemolysis, genotoxicity.
- Histopathology/Microscopic Examination: For implantation studies (inflammation, tissue reaction, absorption, fibrous tissue formation around nerves).
- Direct Observation/Measurement: For physical bench tests (dimensional, tensile strength, pH, etc.).
- Viral Load Measurement: For viral inactivation studies.
- Functional Outcomes/Observation: In the animal study, the ability to confer protection and reduce re-intervention time.
8. Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical medical device. The device's characteristics are inherent to its manufacturing process and material properties, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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(99 days)
Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.
Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the newe and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve. The resilience of the Collagen Nerve Wrap allows the product to recover and maintain closure once the device is placed around the nerve. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.
This document is a 510(k) summary for a medical device called "Collagen Nerve Wrap." The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through a typical clinical trial with acceptance criteria and comparative studies as one might find for a novel drug or a high-risk device.
Therefore, the information you're requesting regarding acceptance criteria, specific study details (sample size for test set/training set, ground truth establishment, expert involvement, MRMC studies, standalone performance), and effect sizes of AI assistance is not typically found in a 510(k) submission for a device like this, as it's not a diagnostic AI device or a device requiring extensive clinical performance measures against predefined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, materials, and safety/biocompatibility testing.
Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not included:
1. A table of acceptance criteria and the reported device performance
This type of table is not applicable here. The submission does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that would be typically seen for diagnostic devices or AI algorithms. Instead, the "effectiveness" is assessed by demonstrating that its characteristics meet design requirements and comparing it to predicate devices.
| Acceptance Criteria (Not explicitly stated as performance metrics) | Reported Device Performance (Summary) |
|---|---|
| Safe (Biocompatibility) | Passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices. |
| Effective (Meets design requirements for a nerve protector) | Characteristics of the Collagen Nerve Wrap meet design requirements for an effective nerve protector. |
| Substantially Equivalent to Predicates | Demonstrated through animal study, in vitro product characterization, in vitro and in vivo biocompatibility studies. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable/provided in the context of typical clinical performance testing as would be requested for an AI diagnostic device. The "test set" here would refer to the animal study and various in vitro and in vivo biocompatibility tests. No specific sample sizes for these individual tests are provided, nor are details on data provenance (e.g., country) or study design (retrospective/prospective) for these tests within this summary.
- Data Provenance: Not specified for the animal study or biocompatibility tests.
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. This device is a resorbable collagen matrix for nerve protection, not a diagnostic tool requiring expert interpretation or "ground truth" establishment in the way an imaging AI algorithm would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, no adjudication method for establishing ground truth is mentioned or relevant for this type of device submission.
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
No. A MRMC study is relevant for diagnostic imaging devices, especially those incorporating AI. This device is a surgically implanted collagen wrap; therefore, an MRMC study is not relevant or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly defined as "ground truth" in this context. For a device like this, "ground truth" would be inferred from the successful completion of biocompatibility tests and the in vivo animal study demonstrating appropriate physiological responses and nerve protection that are comparable to predicate devices. This isn't a diagnostic scenario where a "truth" needs to be established through expert consensus or pathology.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or a ground truth established in the context of machine learning.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" demonstrating the Collagen Nerve Wrap's safety and effectiveness (and thus, its substantial equivalence) consisted of:
- Biocompatibility Testing: The device underwent and passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. These are standard tests designed to assess the biological response to medical devices in contact with the body.
- Animal Study: The submission mentions "The results of an animal study" as contributing to the conclusion of safety and substantial equivalence to its predicates. No specific details about the animal model, study design, or outcomes are provided in this summary.
- In Vitro Product Characterization Studies: These studies would have evaluated the physical and chemical properties of the Collagen Nerve Wrap to ensure it meets its design specifications (e.g., hydration properties, porosity, resilience, degradation profile).
- Comparison to Predicate Devices: The core of the 510(k) submission is the comparison to legally marketed predicate devices (Collagen Nerve Cuff, NeuraWrap™ Nerve Protector, FASTUBE™ Nerve Regeneration Device). The Applicant states that Collagen Nerve Wrap and its predicates have the same technological characteristics, including intended use, design, materials, material characterization, form, and sizes. This forms the basis for the claim of "substantial equivalence."
Conclusion:
The Collagen Nerve Wrap received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices through an animal study, in vitro product characterization, and in vitro and in vivo biocompatibility testing, rather than through a clinical trial with predefined performance acceptance criteria typical for diagnostic or AI-driven medical devices.
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