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VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

VersaWrap Nerve Protector is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment, that starts to absorb after implantation. VersaWrap Nerve Protector is designed to be flexible and conformable for placement on or around a peripheral nerve

The provided FDA 510(k) Clearance Letter for the VersaWrap Nerve Protector outlines the determination of substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a study proving the device meets said criteria in the format requested.

The letter focuses on confirming substantial equivalence based on material composition, mechanism of action, and target population, acknowledging a difference in application method (gel vs. sheet). It summarizes non-clinical tests, including an animal study and bench tests, but these summaries do not include quantitative acceptance criteria or detailed performance data.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Sample Size: For the animal study, the document states "rats underwent various peripheral nerve injuries." The specific number of rats or nerves tested is not provided.
   • Data Provenance: The animal study was "conducted," implying prospective data. The country of origin is not specified.

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

   • Not provided. The document mentions "neurological assessment, and macroscopic and histological evaluation" as methods for evaluating safety and efficacy, which typically involve expert interpretation, but the number or qualifications of these experts are not specified.

3. Adjudication method for the test set:

   • Not provided.

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 nerve protector, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This is a medical device (nerve protector), not a software algorithm.

6. The type of ground truth used:

   • For the animal study:
     • Neurological assessment: Clinical observation/evaluation.
     • Macroscopic evaluation: Gross anatomical inspection.
     • Histological evaluation: Microscopic tissue analysis (pathology).

7. The sample size for the training set:

   • Not applicable / Not provided. For a medical device like this, the concept of a "training set" typically applies to machine learning models, which is not the case here. The development would involve engineering and material science, potentially with iterative testing, but not a formally defined "training set" in the computational sense.

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

   • Not applicable / Not provided. (See point 7).

Summary of Missing Information:

The provided text from the 510(k) clearance letter gives a high-level overview of the non-clinical testing performed (animal study and bench studies) to demonstrate substantial equivalence. However, it lacks the fine-grained details often found in a full study report, such as:

• Specific quantitative acceptance criteria with numerical targets.
• Precise sample sizes for both animal and bench tests.
• Detailed statistical analyses.
• Information about expert qualifications and ground truth establishment methods beyond the types of evaluations performed.

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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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Remplir is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

Remplir™ is a sterile, implantable, biocompatible, resorbable, collagen membrane intended for use in the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Remplir™ is a single-ply sheet of porcine-derived, non-crosslinked collagen. It presents as a soft and pliable, white to off-white membrane with distinct smooth and rough surfaces.

The primary aim of surgical repair is to re-establish nerve continuity so that regenerating axons are guided into the distal nerve stump with minimal loss of nerve fibres at the repair site. Remplir™ is designed to protect the injured nerve. The device can be cut to the desired size and wrapped around the injured nerve in either its wet or dry form. It is wrapped around the site of nerve repair, intended to provide a favourable environment for nerve regeneration and prevent ingrowth of connective tissue.

Remplir™ is supplied as a single device in a double PETG/Tyvek blister pack in a labelled cardboard box. Remplir™ is available in 4 size variants for the convenience of clinicians (15 mm x 20 mm, 20 mm x 30 mm, 30 mm x 40 mm, 40 mm x 50 mm.). All size variants are identical in composition and function.

The Remplir Nerve Cuff is indicated for the management of peripheral nerve injuries where there has been no substantial loss of nerve tissue. The device is a sterile, implantable, biocompatible, resorbable, collagen membrane derived from porcine tissue.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results of the performance testing which successfully met specifications, demonstrating substantial equivalence to the predicate device.

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

The primary in-vivo performance study used a rat transected sciatic nerve model. While the exact number of rats (sample size) is not explicitly stated, the study measured data at 4, 12, and 24 weeks. The provenance of this data is a pre-clinical animal study, typically conducted in-house by the manufacturer or a contract research organization. The country of origin for the data is not specified in the document.

The other performance tests (Suturability, Tensile Strength, Biocompatibility, Sterilization, Endotoxin) are benchtop or laboratory tests, and their "sample size" would refer to the number of device units tested for each specific parameter. These details are not provided in this summary.

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

For the animal study ("Rat transected sciatic nerve model"), the "ground truth" would likely be established through histological examination and evaluation of nerve regeneration and tissue response. The document does not specify the number of experts or their qualifications for interpreting these results. Such expertise would typically involve veterinary pathologists or histologists with experience in nerve tissue assessment.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of the animal study results. It implies that the "changes observed" and "reaction" were assessed and compared.

5. 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 associated with diagnostic imaging devices or AI-assisted diagnostic tools where the performance of human readers with and without AI assistance is evaluated. The Remplir Nerve Cuff is an implantable medical device, and its performance is assessed through bench testing and in-vivo animal studies, not through human reader interpretation. No effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

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

No, a standalone (algorithm only) performance study was not done. Remplir is a physical medical device, not a software algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here.

7. The Type of Ground Truth Used

For the in-vivo animal study, the ground truth was histopathological observation and assessment of the nerve tissue and surrounding environment at different time points (4, 12, and 24 weeks) after implantation. This involves microscopic examination of stained tissue sections to evaluate nerve regeneration, inflammation, and integration of the device. The comparison against a "marketed predicate control material" served as the reference for determining acceptable performance.

For the benchtop tests (Suturability, Tensile Strength, Biocompatibility, Sterilization, Endotoxin), the ground truth is established by pre-defined specifications and validated testing methodologies (e.g., ISO standards, USP monographs) which are considered objective and measurable.

8. The Sample Size for the Training Set

The concept of a "training set" is generally applicable to machine learning algorithms or AI models. Since Remplir™ is a physical medical device and not an AI/ML product, there is no training set in the context of machine learning. The device development would involve design, material selection, and manufacturing process optimization, which are not typically referred to as "training" in this sense.

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

As there is no "training set" for this physical medical device, this question is not applicable.

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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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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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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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VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue.
VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant.
VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.

This document is an FDA 510(k) clearance letter for a medical device called "VersaWrap Nerve Protector." It states that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

This document is specifically for a physical medical device (a nerve cuff), and the content focuses on regulatory clearance based on substantial equivalence to an existing physical predicate device. It addresses aspects like:

• Device Name: VersaWrap Nerve Protector
• Regulation Number/Name: 21 CFR 882.5275, Nerve Cuff
• Product Code: JXI
• Indications for Use: "management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue."
• Predicate Device: VersaWrap Nerve Protector K201631
• Device Description: "thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant."
• Functional and Safety Testing: States "No additional functional or safety testing was required," implying that the substantial equivalence argument, based on the predicate device, was sufficient.
• Comparative Technological Characteristics: Highlights material (Calcium alginate and hyaluronic acid), intended use, physical structure (sheet), and precautions, showing they are identical to the predicate.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML device based on this input, as this document is not about an AI/ML device.

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Axoguard HA+ Nerve Protector is indicated for the management and peripheral nerve injuries where there is no gap, or following closure of the gap.

Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerve injuries. Axoguard HA+ Nerve Protector is designed to aid in coaptation and protection of peripheral nerve injuries by serving as an interface between the nerve and the surrounding tissue and also providing tension relief when used as a coaptation aid. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. When hydrated, Axoguard HA+ Nerve Protector is easy to handle, soft, pliable, nonfriable, and porous. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet the surgeon's needs.

The provided text describes a 510(k) premarket notification for a medical device called "Axoguard HA+ Nerve Protector." This submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device's efficacy through a clinical study in the same way an AI/ML device would be.

Therefore, the requested information elements related to AI/ML device studies (e.g., sample sizes for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this document. This document focuses on demonstrating the safety and performance of a physical surgical implant through bench testing, biocompatibility studies, and non-clinical (animal) studies, primarily by showing it meets predetermined acceptance criteria and is comparable to an existing device.

However, I can provide the acceptance criteria and performance results that are present in the document.

Acceptance Criteria and Reported Device Performance

For this medical device (Axoguard HA+ Nerve Protector), the acceptance criteria are met when the results of various bench tests and biocompatibility assessments demonstrate that the device performs as intended and is safe for its indicated use, showing substantial equivalence to the predicate device. The performance data presented are primarily from bench testing and biocompatibility studies, along with a non-clinical GLP (Good Laboratory Practice) study in rats.

Here's a table summarizing the acceptance criteria (implied by the "Test Method Summary" and the general expectation for medical devices) and the reported device performance:

Regarding the AI/ML specific questions:

• Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML diagnostic or therapeutic. The "test set" here refers to physical samples used in bench tests and animals in a non-clinical study. The non-clinical study used 60 Lewis Rats. The provenance is a laboratory study, not human data.
• 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 like this comes from standardized material testing, chemical analyses, and biological observations in animal models, not human expert consensus on images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For bench testing, the ground truth is defined by the physical or chemical properties measured against established standards (e.g., ASTM, ISO). For biocompatibility, it's the biological response in standardized in-vitro and in-vivo tests. For the non-clinical study, the ground truth was established by histology endpoints for axonal outgrowth, axonal myelination, and gastrocnemius muscle weight in the rat model. This is essentially biological/pathological assessment in an animal model.
• The sample size for the training set: Not applicable, as there is no AI/ML algorithm involved.
• How the ground truth for the training set was established: Not applicable.

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Axoguard HA+ Nerve Protector is indicated for the management of peripheral nerve injuries where is no gap.

The Axoguard HA+ Nerve Protector is a surgical implant that provides non-constricting protection for peripheral nerves. Axoguard HA+ Nerve Protector is designed to be an interface between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is comprised of an extracellular matrix (ECM) and is fully remodeled during the healing process. The lubricant coating on Axoguard HA+ Nerve Protector is composed of sodium hyaluronate and sodium alginate. When hydrated, the lubricant coating reduces friction between the nerve and the surrounding tissue. Axoguard HA+ Nerve Protector is flexible to accommodate movement of the joint and associated tendons and has sufficient mechanical strength to hold sutures. Axoguard HA+ Nerve Protector is provided sterile, for single use only, and in a variety of sizes to meet surgeons' needs.

The provided document is a 510(k) summary for the Axoguard HA+ Nerve Protector. It describes the device, its intended use, and a comparison to a predicate device. It also briefly mentions performance data. However, this document does not contain the detailed information necessary to answer all parts of your request. Specifically, it lacks information on acceptance criteria for each test, the reported performance against those criteria beyond a summary statement, and detailed information about any clinical studies involving human readers or ground truth for training sets.

Here's a breakdown of the information that can be extracted and what is missing:

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

Missing: The document only states that "Test articles met the acceptance criteria" for most tests and "met USP requirement" for Endotoxin. The actual acceptance criteria (e.g., specific force values, friction coefficients, etc.) are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing: The document does not specify the sample sizes used for each performance test. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective/prospective). These are typically non-clinical laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing: This information is not relevant to the types of performance tests described (physical, chemical, and end-user validation of a medical device). "Ground truth" in the context of image analysis or diagnostic AI is not applicable here. The "end-user validation" involved "Surgeon end-users," but the number and specific qualifications (beyond being surgeons) are not provided.

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

Missing: Adjudication methods are typically relevant for studies where expert opinion on subjective assessments (e.g., image interpretation) is being reconciled. It is not applicable to the objective physical and chemical tests described. For the "End-user Validation," it's not clear if there was any formal adjudication process beyond surgeons assessing ease of use and conformance.

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

Missing: This is a physical medical device, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

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

Missing: This question is not applicable as the device is a physical nerve protector, not an algorithm.

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

Missing: This question is not applicable in the typical sense for this device. For the physical and chemical tests, the "ground truth" would be the measured physical properties themselves against predefined standards. For end-user validation, it's subjective feedback from surgeons.

8. The sample size for the training set

Missing: This question is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require training sets.

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

Missing: This question is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require training sets or establishment of ground truth for training.

Summary of what the document does provide regarding acceptance criteria and studies:

The document describes several performance tests, including:

• Coefficient of Friction
• Suture Retention Strength
• Ultimate Tensile Strength
• Bubble Emission (Packaging)
• Seal Strength (Packaging)
• Endotoxin
• End-user Validation

These tests were performed to support the substantial equivalence determination for the Axoguard HA+ Nerve Protector. The study concludes that "These evaluations demonstrate that the device meets the requirements for its intended use" and "Test articles met the acceptance criteria" for the listed tests (or "met USP requirement" for Endotoxin).

Additionally, non-clinical GLP biocompatibility studies were performed to evaluate the effects and biocompatibility of the device on the nerve and surrounding muscle tissue, ensuring compliance with ISO 10993-1. These studies "met all necessary endpoints according to the standard."

The overall conclusion is that "The non-clinical data support the safety of the device and demonstrate that the Axoguard HA+ Nerve Protector performs as intended in its specified use conditions, and is substantially equivalent to its predicate device and does not raise different questions of safety and effectiveness."

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