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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.

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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Cova™MAX is intended for use in oral surgical procedures as a resorbable membrane material for use in:

-Simultaneous use of GBR-membrane (Guided Bone Regeneration) and implants;

-Augmentation around implants placed in immediate extraction sockets;

-Augmentation around implants placed in delayed extraction sockets;

-Localized ridge augmentation for later implantation;

-Alveolar ridge reconstruction for prosthetic treatment;

-Filling of bone defects after root resection, cystectomy and removal of retained teeth;

-Guided bone regeneration in dehiscence defects;

-Guided tissue regeneration procedures in periodontal and recession defects.

Cova™MAX is a resorbable acellular membrane for guided tissue and bone regeneration in dental applications. Cova™MAX membranes are manufactured using a standardized, controlled process. Each Cova™MAX membrane is fabricated solely from Type I collagen extracted from veterinary certified pig tendon. Porcine tendon is known to be one of the purest sources of Type I collagen that can be readily obtained and processed in commercial quantities. It is packaged in a double package and sterilized by gamma irradiation.

Cova™MAX membranes serve as a barrier to guide the healing process between anatomic plans of tissues. It has been designed in accordance with the accepted principles or guided bone regeneration (GBR) as a wound healing material post surgery. They are designed to be resorbable, non inflammatory and biocompatible for uses in clinical periodontics.

The Cova™MAX membrane is completely resorbable within a timeframe compatible with the healing process. 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™MAX is provided in rectangular sheets of 15 x 25 mm, 20 x 30 mm and 30 x 40 mm. Furthermore, the device can be easily trimmed or shaped to the appropriate size, without tearing or fragmenting, to fit the periodontal defect or zone to be treated.

The provided text does not contain detailed acceptance criteria and a study specifically designed to prove the device meets those criteria for the Cova™MAX Resorbable Collagen Membrane. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.

In the context of a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating that the device has similar characteristics and performance to legally marketed predicate devices, and that any differences do not raise new questions of safety or efficacy. The "study" proving this largely relies on comparisons, some preclinical (animal) data, and a review of existing literature.

Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:

Acceptance Criteria and Device Performance (Implicit Basis of Substantial Equivalence)

Study Information (Based on 510(k) Summary)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" for substantial equivalence relied on:
     • Biocompatibility studies (number of samples/animals/tests not specified). Provenance not specified, but typically conducted by certified labs.
     • Animal Data: Literature review of "numerous materials" including predicates across various animal models. The document refers to "a rat implantation study" for the 13-week resorption claim, but no specific sample size is given for Cova™MAX studies. The provenance is implied to be existing literature and an internal rat study.
     • Clinical Data: Literature review of "human studies" consistent with animal studies. No specific clinical study using Cova™MAX is presented. Provenance is existing literature.
   • Data Provenance: Primarily literature review (animal and human studies on guided bone regeneration and similar membranes), and internal biocompatibility tests and a rat implantation study for Cova™MAX. The origin of the literature is not specified, but general "clinical practice of periodontics" is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there was no specific "test set" with ground truth established by a panel of experts for Cova™MAX in this summary. The ground truth for the effectiveness claims comes from the established scientific literature on Guided Bone Regeneration (GBR) and similar resorbable membranes, which implicitly relies on the consensus and findings of experts in the dental and periodontal fields over time.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There was no specific test set requiring adjudication in this 510(k) summary.

4. 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:

   • Not applicable. This device is a resorbable collagen membrane, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as this is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For safety, ground truth was established through standard biocompatibility tests (cytotoxicity, irritation, systemic toxicity, genotoxicity, pyrogenicity, implantation/absorption, sub-chronic/chronic toxicity, hemolysis) and compliance with animal tissue sourcing and viral inactivation standards.
   • For effectiveness, the ground truth is derived from the established scientific understanding and clinical acceptance of Guided Bone Regeneration (GBR) and Guided Tissue Regeneration (GTR) using resorbable barrier membranes, as documented in animal model studies and human clinical literature. This is a form of expert consensus and accumulated outcomes data from past research and clinical practice.

7. The sample size for the training set:

   • Not applicable for a physical device in the context of a 510(k) submission showing substantial equivalence. There isn't a "training set" in the sense of machine learning. The "training" for the device design and manufacturing would implicitly come from general scientific knowledge, material science, and the characteristics of existing predicate devices.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as point 7. The "ground truth" for developing Cova™MAX was the established scientific and clinical understanding of what constitutes a safe and effective resorbable collagen membrane for GBR/GTR, based on decades of research and predicate device performance.

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