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Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets.

The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons.

When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.

The provided text is a 510(k) summary for the Mochida Nerve Cuff, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for an AI/ML-based medical device. Therefore, it does not contain the specific information required to answer the questions about AI/ML device acceptance criteria and study designs (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details).

This document outlines:

• Device Description: Mochida Nerve Cuff is made from polyglycolic acid (PGA) sheet embedded in covalently cross-linked alginate gel, designed to repair peripheral nerve function by providing a scaffold for axon growth.
• Indications for Use: Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or management of peripheral nerve injuries with no substantial loss of nerve tissue.
• Predicate Devices: Collagen Matrix, Inc.'s Collagen Nerve Wrap (K060952) and Collagen Matrix, Inc.'s Collagen Nerve Cuff (K012814).
• Technological Characteristics Comparison: The document emphasizes the similarities in material biodegradability, form (sheet/wrap), fundamental science (scaffold for nerve cell growth), and single-use sterile presentation.
• Performance Data (Non-AI/ML):
  • Stability testing: Real-time and accelerated aging for product and packaging.
  • Transportation testing: According to ASTM D4169-22.
  • Pyrogenicity testing: Demonstrates non-pyrogenic status.
  • Biocompatibility testing: Conducted per ISO 10993-1, including chemical characterization, cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute toxicity, pyrogenicity, and genotoxicity. Note: Hemolysis testing conclusion states "No conclusion was drawn for hemolytic potential."
  • Bench testing: Comparative tests for tensile strength, suture retention strength, pH, stiffness, degradation, swelling rate, and porosity.
  • Animal study: Two rat sciatic nerve models (transection and no transection) compared the Mochida Nerve Cuff to predicate devices and included a sham arm. Results demonstrated similar safety and performance to predicate devices.

Conclusion: The document concludes that the Mochida Nerve Cuff is substantially equivalent to the predicate devices based on intended use, indications, technological characteristics, and performance testing.

Therefore, I cannot provide the requested information about acceptance criteria and study designs for an AI/ML medical device, as the provided text describes a non-AI/ML nerve cuff device.

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The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.

The EARP Nerve Cuff Electrode conducts electrical signal as a component of intraoperative neuromonitoring. The EARP Nerve Cuff Electrode is used with commercially available neuromonitoring systems and does not stimulate or record signal itself. The standard connectors at the proximal end of the EARP Nerve Cuff Electrode interface with the neuromonitoring equipment and the distal cuff contacts the target tissue. The EARP Nerve Cuff Electrode is provided sterile packaged and is for single use only.

The provided text describes the 510(k) summary for the EARP Nerve Cuff Electrode, a surgical nerve stimulator/locator. It does not pertain to an AI/ML medical device, but rather a physical medical device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device's performance are not present in this document.

However, I can extract the information related to the acceptance criteria and the study that proves the physical device meets these criteria, based on the provided FDA 510(k) summary.

Here's an attempt to answer as much as possible given the limitations of the provided text, recognizing that it's for a traditional medical device, not an AI/ML one:

Acceptance Criteria and Device Performance for the EARP Nerve Cuff Electrode

Since this is a physical medical device submission, the "acceptance criteria" are based on non-clinical performance and biocompatibility testing, demonstrating the device's safety and effectiveness in its intended use, and its substantial equivalence to predicate devices. The "study" refers to the non-clinical testing performed.

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

The document lists "Summary of Non-Clinical Testing" which serves as the "study" proving the device meets the acceptance criteria. The acceptance criteria are implied by the "Conclusion" column (e.g., "no evidence of causing cell lysis or toxicity" for cytotoxicity), and the "Pass/Fail" column indicates whether the device met these criteria.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of units, animals, or test replicates) for each test. It mentions "mice" and "guinea pig" for specific biocompatibility tests, implying the use of animal models according to the ISO standards.
• Data Provenance: The provenance is through laboratory testing conducted on the device components or extracts. The document does not specify the country of origin where the tests were performed, nor whether the data involved retrospective or prospective collection of patient data, as this is laboratory testing of a physical device.

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

This concept is not applicable to the type of device described. "Ground truth" established by experts is typically relevant for interpretative devices like AI/ML products where human experts provide labels or diagnoses for comparison. For a physical medical device like an electrode, the "ground truth" is established by adherence to recognized performance standards (e.g., ISO, IEC, USP) and validated laboratory test methodologies. The "experts" would be the qualified personnel performing and interpreting these specific laboratory tests.

4. Adjudication method for the test set

This concept is not applicable as there is no "adjudication" of human interpretations for this type of device. The results are based on objective measurements from standardized laboratory tests.

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

This concept is not applicable as this is not an AI/ML device, and no human reader study was performed.

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

This concept is not applicable as this is not an AI/ML device and does not involve an algorithm. The device's "standalone" performance is assessed through its physical characteristics and electrical/biocompatibility safety in laboratory settings.

7. The type of ground truth used

The "ground truth" for this physical device is established by:

• Established Performance Standards: Adherence to ISO, IEC, and USP standards for biocompatibility, electrical safety, and mechanical integrity.
• Objective Measurements: Laboratory measurements of physical, chemical, and electrical properties compared against pre-defined specifications derived from these standards or engineering requirements.

8. The sample size for the training set

This concept is not applicable as this is not an AI/ML device that requires a training set.

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

This concept is not applicable as this is not an AI/ML device that requires a training set.

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The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.

The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm.

The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated.

Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals.

The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "NervAlign Nerve Cuff." It focuses on demonstrating the substantial equivalence of the NervAlign Nerve Cuff to a legally marketed predicate device (AxoGuard Nerve Protector; K132660).

Based on the provided document, the device (NervAlign Nerve Cuff) is not an AI/ML powered device, nor does it involve human-in-the-loop performance, or a comparative effectiveness study with human readers (MRMC). Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "Number of experts used to establish the ground truth for the test set and the qualifications of those experts", are not applicable to this specific device submission.

This submission relies on non-clinical performance testing to demonstrate substantial equivalence, rather than clinical studies involving human performance or diagnostic accuracy.

Here's the information that is applicable and can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in a numerical or pass/fail table format with specific thresholds. Instead, the "Results" column from the "Performance Data" section effectively serves as the reported device performance and implicitly demonstrates that the device met the necessary standards for its intended use and for demonstrating substantial equivalence to the predicate.

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Reinforced Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue).

Reinforced Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular matrix circumferentially supported with a resorbable synthetic polymer filament. The device provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. The synthetic polymer filament provides enhanced support for biomechanical stability and kink-resistance of the collagen conduit. The Reinforced Flexible Collagen Nerve Cuff is an interface between the nerve and the surrounding tissue to prevent ingrowth of scar tissue. When implanted at a severed peripheral nerve gap, the Reinforced Flexible Collagen Nerve Cuff provides guidance for axonal growth across the gap. Upon hydration, the Reinforced Flexible Collagen Nerve Cuff is a soft, flexible collagen conduit with compression-resistant and kink-resistant properties. It is supplied sterile, nonpyrogenic, in various sizes and for single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Reinforced Flexible Collagen Nerve Cuff." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested sections related to acceptance criteria, MRMC studies, standalone performance, and ground truth establishment for AI/ML models cannot be extracted or inferred from this document. This document details the regulatory approval process for a biomedical device based on non-clinical and animal studies, not an AI/ML algorithm.

However, I can extract information related to the device's performance based on the comparison to the predicate device in the provided non-clinical and animal studies.

Here's the information that can be extracted, and an explanation of why other requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in terms of precise numerical thresholds for clinical performance (e.g., sensitivity, specificity) as would be the case for an AI/ML medical device. Instead, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device through various non-clinical and animal studies, showing comparable safety and performance characteristics.

The "performance" is reported as being "comparable" to the predicate device or passing standard biological tests.

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Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue) or at the end of the nerve in the foot to reduce the formation of symptomatic or painful neuroma.

Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular matrix that provides both an encasement for peripheral nerve injuries as well as protection of the neural environment. Flexible Collagen Nerve Cuff is designed to be an interface between the nerve and the surrounding tissue (e.g., to prevent ingrowth of scar tissue). When placed at the terminal end of a nerve, the Flexible Collagen Nerve Cuff is designed to prevent formation of neuroma. When hydrated, Flexible Collagen Nerve Cuff is a flexible collagen conduit where the crimped walls provide a kink-resistant property to the tube. It is supplied sterile, non-pyrogenic, in various sizes and for single use only.

The provided text describes a 510(k) summary for the Flexible Collagen Nerve Cuff, which is a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device for expanded indications, rather than conducting a de novo study with acceptance criteria and device performance evaluation in the typical sense of AI/ML device studies.

Therefore, many of the requested categories related to AI/ML device studies (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable or cannot be extracted from this document, as it concerns a physical medical device.

Here's the information that can be extracted from the document regarding its "acceptance criteria" (understood as demonstrating safety and equivalence) and the "study" (clinical and non-clinical evaluations):

1. Table of "Acceptance Criteria" (demonstrated safety and equivalence) and the "Reported Device Performance":

Since this is a physical device seeking expanded indications based on substantial equivalence, the "acceptance criteria" are implied by demonstrating equivalence to predicate devices and meeting safety standards. The reported "performance" is primarily for the clinical outcome associated with the expanded indication.

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

• Sample Size (Clinical Study): 50 patients (30 right, 20 left sides; 1 patient bilateral)
• Number of Nerves Treated: 60 nerves
• Data Provenance: Not explicitly stated, but implies a prospective or retrospective single-center clinical study for the 50 patients who underwent surgery with the device. The meta-analysis involved "published studies."

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

• Not Applicable in the AI/ML sense. The clinical study evaluated patient-reported pain reduction, not expert-adjudicated images or diagnoses. The "ground truth" for success was the patient's self-reported pain score change.

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

• Not Applicable in the AI/ML sense. The clinical study relied on patient self-reported pain scores.

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, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI/ML diagnostic tool involving human readers.
• However, a clinical literature review and meta-analysis was conducted to compare the device's clinical performance (pain reduction) to its predicate device (Silastic Nerve Cuff) and nerve excision alone.
  • Effect Size: The analysis concluded that the Flexible Collagen Nerve Cuff "performs substantially equivalent to its predicate device (Silastic Nerve Cuff) with respect to reduction of pain post-operatively." Additionally, "both devices show clinically significant improvement in pain reduction over the excision-only control group." No specific numerical effect size (e.g., odds ratio, mean difference) is provided for the improvement.

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

• Not Applicable. This is a physical device, not an algorithm. Its performance is inherent to its material properties and clinical application.

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

• Patient-reported outcomes data: For the clinical study, the "ground truth" for effectiveness was the patient's self-reported pain score (1-10 scale) before and after surgery.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable.

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The Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.

The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate Nerve Cuff (K031069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in clamshell container inside a sealed double pouch system.

The document describes the acceptance criteria and study results for the Cook Biotech Incorporated Nerve Cuff (K132660). The submission focuses on demonstrating substantial equivalence to a predicate device (Surgisis Nerve Cuff, K031069) through bench, biocompatibility, and animal studies.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state quantitative "acceptance criteria" for each test in the way you might find in an AI/software device submission. Instead, it demonstrates performance by showing that the Nerve Cuff is "substantially equivalent" to its predicate device or meets specific qualitative standards.

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The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.

Acceptance Criteria and Study for SURGISIS® Nerve Cuff

This document summarizes the acceptance criteria and the studies conducted to demonstrate that the SURGISIS® Nerve Cuff meets these criteria, based on the provided 510(k) summary (K031069).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly state the sample sizes used for the in vitro or in vivo test sets for the SURGISIS® Nerve Cuff, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance."

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for any of the tests conducted. The testing appears to be primarily laboratory-based (biocompatibility, viral inactivation, mechanical) and animal-based (in vivo performance), rather than relying on expert clinical assessment of a test set in the way an AI/CAD system might.

4. Adjudication Method for the Test Set

Not applicable. The types of tests described (biocompatibility, viral inactivation, mechanical, in vivo animal studies) do not typically involve an adjudication method by human experts in the context of establishing a clinical ground truth for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The summary describes a medical device (nerve cuff) and its performance, not an AI or CAD system. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable to this device.

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

Not applicable. This device is a physical implantable nerve cuff, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the various tests can be inferred as follows:

• Biocompatibility: Established through standardized in vitro and in vivo biocompatibility testing methods, likely involving cellular responses, tissue reactions, and toxicology assessments.
• Viral Inactivation: Established by validated laboratory assays to detect viral agents following the manufacturing process.
• Mechanical Properties (Tensile Strength, Suture Retention, Compressive Forces): Established through standardized engineering and materials testing methods using calibrated equipment.
• In Vivo Performance (Axonal Growth and Myelination): Established through histological analysis, immunohistochemistry, and potentially functional recovery assessments in an animal model, compared to control groups (e.g., empty cuff or direct repair).

8. The Sample Size for the Training Set

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

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

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

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Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protective environment for peripheral nerve repair after injury and to create a conduit for axonal growth across a nerve gap.

The Collagen Nerve Cuff is a medical device intended for the repair of peripheral nerve discontinuities. The following outlines the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: The primary evidence supporting the device's performance for this 510(k) relies on a literature review of animal and human studies.
  • Animal Data: "animal studies over the past twenty years using nerve conduit have been reviewed." The specific sample size (number of animals, number of studies) is not provided.
  • Clinical Data: "The results reported in the literature demonstrated efficacy of peripheral nerve repair using resorbable and non-resorbable biocompatible nerve conduits." The specific sample size (number of patients, number of studies) is not provided.
  • Data Provenance: The document does not specify the country of origin of the data for the literature review. The studies are retrospective, as they involve the review of existing published literature.
• Simulated Clinical Environment Studies: These were performed to evaluate mechanical and physical characteristics. No specific sample size (e.g., number of cuffs tested) is provided.

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

• For the literature reviews (animal and clinical data), the "ground truth" implicitly comes from the findings and conclusions of the researchers who conducted those original studies. The 510(k) summary itself does not detail how many experts retrospectively reviewed and established the ground truth from the existing literature, nor does it specify their qualifications.
• For the simulated clinical environment studies, the "ground truth" is based on objective measurements of mechanical and physical properties. This typically involves technical experts in materials science or biomedical engineering, but their number and qualifications are not specified in this document.

4. Adjudication Method for the Test Set

• Given that the primary evidence comes from a literature review and simulated clinical studies rather than a prospective clinical trial with a defined test set of patients, a formal adjudication method (e.g., 2+1, 3+1) for clinician review of patient outcomes is not applicable or described in this 510(k) summary. The summary relies on the conclusions drawn by the authors of the original studies in the literature and the results from the simulated clinical environment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done for this device submission. The submission relies on a review of existing literature and simulated clinical testing, not a study comparing human readers with and without AI assistance. The device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical medical implant (nerve cuff), not a software algorithm or AI-based system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Literature Review (Animal and Clinical): The ground truth for effectiveness is derived from the published results and conclusions of scientific studies in the literature on nerve repair using conduits. This would include histological observations, functional recovery assessments, and potentially patient outcomes reported in those studies.
• Biocompatibility: Ground truth is established through standardized biocompatibility testing (e.g., ISO 10993) where specific biological responses are measured against predefined acceptable limits.
• Simulated Clinical Environment: Ground truth for technical characteristics is based on objective measurements of physical and mechanical properties (e.g., tensile strength, flexibility, permeability) against design specifications deemed adequate for the intended use.

8. The Sample Size for the Training Set

• Not applicable. This device submission does not involve a machine learning algorithm that requires a "training set." The evidence for the device's safety and effectiveness comes from a review of existing scientific literature, biocompatibility testing, and simulated clinical environment studies.

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

• Not applicable. As there is no training set for a machine learning algorithm, the establishment of ground truth for such a set is not relevant to this submission.

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Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity

The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap. The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.

The provided text describes the SaluMedica™ Nerve Cuff and its non-clinical evaluation for a 510(k) submission. It does not contain information about a study involving a device and its acceptance criteria in the way a medical AI/software device would. The tests described are for a physical medical device (a nerve cuff), focusing on its physical and biological properties.

Therefore, many of the requested categories for AI/software device evaluations are not applicable. I will extract the relevant information regarding the non-clinical tests performed for this physical device where possible.

Acceptance Criteria and Reported Device Performance

Based on the provided text, the following information is not applicable as the document describes a physical medical device (nerve cuff), not an AI/software device or diagnostic tool typically evaluated with such metrics:

1. Sample size used for the test set and the data provenance: Not applicable. The tests were for physical and biological properties of the nerve cuff, not a dataset.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to established material science and biological standards, not expert consensus on diagnostic images or outputs.
3. Adjudication method: Not applicable.
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.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical device, ground truth would be established scientific principles and measured physical/biological properties, not expert consensus on data interpretation.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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