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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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NerveTape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

The proposed BioCircuit Technologies, Inc. NerveTape device is composed of a bioabsorbable, extracellular collagen matrix (small intestinal submucosa, SIS) with integrated microhooks made of a nickel-titanium alloy, commonly referred to as NiTiNOL (identical to the predicate), for mechanical fixation and apposition of nerve ends. The NerveTape is implanted around an injured nerve to provide a scaffold which becomes infiltrated and remodeled by the patient's cells. The device protects the damaged or severed nerve while the nerve heals.

The device is packaged and supplied sterile in a clamshell container inside a sealed pouch. The device is identical to the predicate, except for the SIS substrate manufacturer and the addition of a smaller size. The dimensions of the finished device range from 11mm x 12mm x 22mm. The device is intended for the repair of nerves of diameters ranging from 1.5mm to 7mm.

Here is an analysis of the provided text regarding the NerveTape device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Performance Verification (Ease of Use, Monotonic Tensile Strength): The text states "All samples met acceptance criteria," implying a sample size was used for these tests, but the exact number of samples is not specified.
• Biocompatibility Testing:
  • Device Biocompatibility (largest size, sterile product): "all testing performed on sterile product of largest size" – implies at least one sample of the largest size was used for each test. Specific sample numbers (e.g., number of mice, rabbits, cell samples) are mentioned within the individual test summaries (e.g., "rabbits" for irritation, "guinea pigs" for sensitization, "mice" for systemic toxicity) but not a precise cumulative number.
  • Decellularized Porcine Small Intestine Submucosa (SIS) Biocompatibility (raw material): "all testing performed on non-sterile, decellularized porcine small intestine raw material - SIS" – similar to device testing, specific animal counts are mentioned for relevant tests.
• Animal Studies: "a statistically valid number of rabbits" underwent implantation. The exact number of rabbits is not specified beyond being "statistically valid."
• Data Provenance: The studies are non-clinical (laboratory/animal studies). The biological components (porcine SIS) originate from pigs. The testing appears to be conducted in a controlled lab setting, not specified by country, but implies in-house or contracted lab testing for regulatory submission. All studies are prospective tests conducted on the device/material.

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

There is no information provided regarding experts establishing "ground truth" in the traditional sense for these non-clinical, performance, and biocompatibility tests. The "ground truth" for these tests is based on established scientific standards (e.g., ISO, AAMI, USP protocols) and objective measurements or observations (e.g., cell morphology, tensile strength, histological evaluation, chemical quantification). For the "Ease of Use" test, "acceptability to the end-user" implies evaluation by surgeons, but the number and qualifications of these surgeons are not specified.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical tests. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where expert consensus is needed to resolve discrepancies in subjective assessments. Here, the results are based on objective measurements against predefined criteria/standards.

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 medical device (nerve cuff), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for most tests is based on:

• Established scientific standards and normative values: e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, literature for standard suture repair strength.
• Objective measurements and observations: e.g., cell morphology, concentration of residuals, temperature changes, histological findings, tensile strength measurements, dimensional/visual inspection.
• Comparison to a predicate device: For performance tests, the proposed device's performance is compared directly against the predicate device to demonstrate substantial equivalence or superiority.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. 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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Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.

The Nerve Tape device is composed of a bioabsorbable, extracellular collagen matrix derived from small intestinal submucosa (SIS). Microhooks made of a nickel-titanium alloy (NiTiNOL) are integrated into the nerve contacting side of the SIS for mechanical fixation and apposition of nerve ends. The device is packaged in a dried state and supplied sterile, and is rehydrated prior to use.

The provided text outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Nerve Tape device to predicate devices, rather than a study proving the device meets general acceptance criteria in a comparative effectiveness study with human readers.

However, based on the information provided for the Neve Tape device, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed against these predicate devices and established standards.

2. Sample sized used for the test set and the data provenance

• User Handling Validation/Ease of Use: "All samples met acceptance criteria." The specific sample size for the rabbit tibial nerve cases is not explicitly stated, but it involved multiple surgeons performing applications.
• Monotonic Tensile Strength: "All samples met acceptance criteria." The specific sample size of cadaveric nerve repairs is not explicitly stated.
• Animal Studies: The study used a rabbit tibial nerve transection model. Specific sample sizes for the number of rabbits or nerve repairs are not given, but evaluations were performed at 4-week or 16-week time points. This is prospective animal data.

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

• User handling validation/Ease of Use: "Surgeon performance and handling... were assessed for ease of use". The number of surgeons and their specific qualifications are not detailed beyond being "surgeons." They were implicitly the "experts" assessing ease of use.
• Animal Studies: "Outcome measures included macroscopic assessment of the nerve implant sites, muscle weight and girth, and histological assessment of the implant sites and surrounding tissues." These assessments would have been performed by qualified individuals (e.g., veterinary pathologists, histologists), but the specific number and qualifications are not mentioned.

4. Adjudication method for the test set

The document does not describe a formal adjudication method for ground truth in the context of human expert review. The "acceptance criteria" are based on performance metrics against established standards or predicate devices, and internal assessments (e.g., "All samples met acceptance criteria").

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 such MRMC study was performed or described. This submission relates to a physical medical device (Nerve Tape), not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable here.

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

This refers to a physical medical device, not an algorithm. Therefore, "standalone algorithm-only performance" is not applicable.

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

The "ground truth" for the device's performance was established through:

• Quantitative measurements against standards: For mechanical properties (tensile strength), material properties (corrosion resistance, transformation temperature), and dimensional compliance.
• Compliance with validated protocols: For biocompatibility and sterilization.
• Direct observation and assessment: By surgeons for ease of use.
• Histological assessment and macroscopic evaluation: For the animal study, which serves as a form of "pathology" and direct physiological outcome data.

8. The sample size for the training set

This document describes a premarket notification for a physical medical device. The concepts of "training set" and "test set" are typically used in the context of machine learning (AI) models. While the manufacturer likely conducted internal development and testing during the design phase, the document does not present data in terms of a formal "training set" like one would for an AI algorithm.

9. How the ground truth for the training set was established

As above, the concept of a formal "training set" and its "ground truth" as it applies to AI/ML devices is not relevant to this submission for a physical medical device. The "ground truth" for the various non-clinical and animal studies described were established through standardized test methods, material specifications, and biological evaluations.

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