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Nerve Wrap is indicated for the management of peripheral nerve injuries where there is no gap.

The proposed BioCircuit Technologies, Inc. Nerve Wrap device is composed of a bioabsorbable, layered extracellular collagen matrix (decellularized porcine small intestinal submucosa, SIS). The SIS material that comprises the Nerve Wrap is identical to the backing material of its reference predicate, Nerve Tape (K233533). The Nerve Wrap is implanted around a damaged peripheral nerve to provide a scaffold which becomes infiltrated and remodeled by the patient's cells. The device protects the nerve while the nerve heals and provides a non-constricting interface between the nerve and the surrounding tissue.

The device is packaged and supplied sterile in a clamshell container inside a sealed pouch. The dimensions of the finished device are 45mm x 22mm, with 2 - 3 layers of laminated SIS. The device is intended for implantation around nerves of diameters up to 7mm.

This FDA 510(k) clearance letter and summary concern a medical device (Nerve Wrap) and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training set) are not applicable.

However, I can provide information about the acceptance criteria and the study that demonstrates the device (Nerve Wrap) meets those criteria based on the provided document.

Acceptance Criteria and Reported Device Performance

The Nerve Wrap device underwent non-clinical tests to characterize its performance and ensure biocompatibility. The summary indicates that "All samples met their acceptance criteria" for these tests, and the device was found to be "substantially equivalent or superior to the control device" in an animal study.

Here's a table summarizing the acceptance criteria implicitly or explicitly mentioned and the reported performance based on the non-clinical tests:

Study Details (Non-AI/ML Device)

Since this is a non-AI/ML medical device, the following points address the relevant aspects of its validation:

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

   • Biocompatibility Testing:
     • In Vitro Cytotoxicity (Device): Not specified, but standard cell line testing.
     • Sensitization (Device): Guinea pigs (number not specified).
     • Intracutaneous Irritation / Reactivity (Device): Rabbits (number not specified).
     • Acute Systemic Toxicity (Device): Mice (number not specified).
     • Subacute/Subchronic Toxicity (SIS Material): Male and female rats (number not specified).
     • Genotoxicity (SIS Material): Cultured Chinese Hamster Ovary (CHO) cells and bacterial strains (Salmonella typhimurium, Escherichia coli).
     • Intramuscular Implantation (SIS Material): Not specified (likely rabbits or rodents typical for such studies).
     • Material Mediated Pyrogenicity (SIS Material): Rabbits (number not specified).
   • Animal Study: Rabbits, a "statistically valid number" (specific number not provided).
   • Data Provenance: The studies were conducted to international standards (ISO, USP, AAMI TIR) which are widely accepted. The country of origin for the studies is not specified in the document. All testing appears to be prospective as it was conducted specifically for the device's clearance.

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

   • This concept is not directly applicable to the type of non-clinical device testing described. Ground truth is established by the well-defined and standardized protocols of the ISO/AAMI/USP tests themselves, which have established scientific validity and are interpreted by qualified laboratory personnel following these standards. There is no "test set" in the AI/ML sense requiring expert annotation for ground truth.

3. Adjudication method for the test set:

   • Not applicable. The tests are based on objective measurements and established scientific protocols rather than expert adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. This device is a nerve wrap, not an imaging or diagnostic AI.

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

   • Not applicable, as this is not an AI/ML algorithm-based device. The device's performance is standalone in the sense that it functions physically; its "performance" is its material properties and biological interaction, which were tested independently.

6. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and scientific protocols (e.g., ISO 10993 series, USP , ISO 11135). For the animal study, the ground truth refers to the physiological responses and healing observed in the animal model, compared against control devices.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device requiring a training set.

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

   • Not applicable, as there is no training set for this device.

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