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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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AxoGen Nerve Cap is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of symptomatic or painful neuroma.

The AxoGen Nerve Cap is a surgical implant that is a tubular device with one open end, one sealed end (cap) and internal channels designed to provide protection for a peripheral nerve end or stump where repair is unattainable or not desired. The device prevents dislocation of the nerve end by pulling the nerve into the tube, suturing the nerve within the cap, and securing the tab to the surrounding tissue.

AxoGen Nerve Cap is an extracellular matrix (ECM) and is fully remodeled during the healing process. The device is manufactured from processed porcine small intestinal submucosa (SIS) which is vacuum pressed prior to packaging. After hydration, the device is easy to handle, soft, pliable, non-friable and porous.

AxoGen Nerve Cap is flexible to accommodate movement of the joints and surrounding soft tissues and has sufficient mechanical strength to hold appropriately sized nonabsorbable suture. It is supplied in nominal tube diameters ranging from 1.5mm up to 8mm, and a length of 13mm-38mm. AxoGen Nerve Cap is provided sterile, for single use only, and in a variety of sizes to meet clinical needs.

The provided text describes the AxoGen Nerve Cap, a medical device, and its journey through the 510(k) premarket notification process for FDA clearance. The submission focuses on demonstrating substantial equivalence to predicate devices based on various performance specifications and biocompatibility testing.

However, the provided text does not contain any information related to a study involving human or expert readers, AI assistance, complex ground truth establishment for a test or training set, or sample sizes related to such studies. The performance specifications primarily relate to the physical and biological properties of the device itself (e.g., suture retention strength, tensile strength, biocompatibility, usability in a handling context).

Therefore, I cannot fulfill most of your request as the information is not present in the provided document. I can only extract criteria and performance related to the physical device.

Here's what I can provide based on the given text:

Acceptance Criteria and Reported Device Performance for AxoGen Nerve Cap

The acceptance criteria here refer to the performance specifications of the physical device and its material properties, not the performance of an AI algorithm or human reader study.

1. Table of Acceptance Criteria and Reported Device Performance

The following sections are either "Not Applicable" (N/A) or "Not Provided" in the text, as the document discusses a physical medical device and not an AI/human-reader study.

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

• Sample Size: Not specified for a "test set" in the context of an AI/human reader study. For physical testing (e.g., shear, tensile, biocompatibility), the document refers to "samples" without specifying the number per test. The animal study involved a "chronic rat tibial nerve transposition (TNT) model" and "Control groups were also implanted," but specific group sizes are not given.
• Data Provenance: Not applicable in the context of typical AI/human reader study data provenance (e.g., country of origin, retrospective/prospective). The studies are laboratory and animal-based performance tests of the physical device.

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

• N/A. Ground truth for an AI/human reader study is not applicable here. The "ground truth" for the device's performance is established by the results of the physical and biological tests against specified criteria and through the animal study.

4. Adjudication method for the test set

• N/A. No adjudication method for a test set of human/AI readings is described.

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

• N/A. No MRMC study was described. This is a physical medical device, not an image analysis or diagnostic AI.

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

• N/A. There is no AI algorithm. The "standalone performance" refers to the physical device itself meeting its specifications.

7. The type of ground truth used

• For the physical properties and biocompatibility: These are based on mechanical testing standards, biological evaluation standards (ISO 10993-1, ISO 10993-7), and sterilization standards (EN ISO 11135:2014).
• For the non-clinical efficacy (neuroma reduction): This was established through an animal model (chronic rat tibial nerve transposition (TNT) model), with outcomes measured by "containment of nerve end and subsequent outgrowth, a reduction in nerve width measurements, and overall reduced sensitivity to mechanical stimulation."

8. The sample size for the training set

• N/A. There is no "training set" as this is not an AI/machine learning device.

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

• N/A. There is no "training set" or AI-specific ground truth.

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