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Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap. The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.

This document describes the premarket notification for the "Rebuilder Nerve Guidance Conduit" (K230794). It is a medical device intended for the reconstruction of peripheral nerve discontinuities.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Neurolac Nerve Guide (K112267). The study aimed to show that the Rebuilder Nerve Guidance Conduit performs similarly to the predicate across various characteristics.

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

• Mechanical and Chemical Testing: The document does not specify the exact sample sizes for these tests. It generally states that "Non-Clinical Tests were conducted and performed on the subject device and predicate device."
• Biocompatibility Testing: The sample sizes for individual biocompatibility tests (e.g., cytotoxicity assays) are not provided in this summary.
• In Vivo Animal Testing:
  • Sample Size: Not explicitly stated as a number of animals, but refers to "a rat nerve sciatic nerve transection model." This implies a group of rats for the test article and a group for the comparator control.
  • Data Provenance: Prospective animal study conducted in a laboratory setting (rat model). Country of origin is not specified.

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

This type of information is generally not applicable to a device like a nerve guidance conduit, as the "ground truth" is established through objective performance measures (mechanical, chemical, biological, and functional outcomes) rather than expert interpretation of images or clinical reports. Therefore, no experts were used for establishing ground truth in the traditional sense of diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established through objective measurements and not subjective expert evaluation requiring adjudication.

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

Not applicable. This device is a physical implant, not an AI software intended to assist human readers in diagnostic tasks.

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

Not applicable. This device is a physical implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for evaluating the device's performance was established using a combination of:

• Objective Laboratory Measurements: Suture retention strength, compression properties, chemical analysis, degradation properties, and various in vitro biocompatibility assays.
• Pathology/Histology: Histological assessments of implantation sites for inflammation, nerve fiber density, and axonal myelination in the animal study.
• Outcomes Data (Animal Functional Outcomes): Sciatic Function Index using walking tracks in the rat model.
• Macroscopic Assessments: Observation of nerve implant sites for tissue adhesions in the animal study.
• Clinical Pathology (Animal): Hematology and serum chemistry in the animal study.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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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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The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Neurolac® (4-10 mm) is designed to be a flexible and transparent resorbable poly(DL-lactide-co-s-caprolactone) tube to provide a protective environment for peripheral nerve regeneration, for nerves with an internal diameter ≤ 9.5 mm, after injury and to create a conduit to guide axonal growth across a nerve gap. Neurolac® (4-10mm) nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes (4, 5, 6, 7, 8, 10 mm).

The provided text describes a 510(k) premarket notification for the Neurolac® (4-10 mm) nerve guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance studies with sample sizes, expert involvement, and ground truth establishment are not typically part of a 510(k) submission and are not present in the provided documents.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document because this is a 510(k) submission demonstrating substantial equivalence to predicate devices, rather than a de novo submission or PMA requiring explicit performance acceptance criteria and reporting. The "Performance Data" section in {1} outlines what kind of tests were performed (in vitro, in vivo), but doesn't list specific quantitative acceptance criteria or results in a table format.

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

Again, this level of detail for specific test sets with sample sizes and data provenance (country, retrospective/prospective) is not explicitly provided in the context of the 510(k) submission. The document mentions "design verification tests and analyses" and "in vivo nerve function recovery," but doesn't detail the sample sizes or provenance for these tests. The primary "study" is the comparison to predicate devices and reliance on pre-existing data (K032115).

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

This information is not provided. The 510(k) process for this device relies on demonstrating equivalence rather than establishing new clinical ground truth through expert consensus.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided. MRMC studies are typically for evaluating diagnostic imaging devices or other technologies where human readers interpret results, which is not directly applicable to a nerve guide.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/not provided. The Neurolac® nerve guide is a medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Neurolac® (4-10 mm) nerve guide's safety and effectiveness relies on:

• Substantial Equivalence to Predicate Devices: The primary "ground truth" is that the Neurolac® (4-10 mm) nerve guide is substantially equivalent in design, fundamental technology, and intended use to previously cleared devices:
  • Salumedica™ nerve cuff, Salumedica, K002098
  • Neurogen™ nerve guide, Integra life science, K011168
  • Neurolac® nerve guide, Polyganics BV, K032115 (the 1-3 mm version)
• Pre-clinical data: "Biocompatibility, mechanical and chemical and physical property testing, in vitro degradation testing and performance testing, clinical testing and testing in an animal model provide scientific evidence that Neurolac (1-3 mm) nerve quide (510(k) 032115) is safe for implantation." {1}
• Literature and Comparison: "Evaluation of the Polyganics Neurolac (4-10 mm) nerve guide based on results from literature and the comparison of the Neurolac (4-10 mm) nerve guide with its predicate devices, shows that the material of which the Neurolac (4-10mm) nerve guide is made, is safe for implantation." {1}

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms, which is not applicable here. The safety and effectiveness are established through reference to predicate devices and pre-clinical data, not an AI training process.

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

As explained above, this concept of "training set" and associated ground truth establishment is not applicable to this device.

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