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The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix. NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.

This document is a 510(k) premarket notification for a medical device called the "NeuraGen® 3D Nerve Guide Matrix." It focuses on demonstrating substantial equivalence to a previously marketed predicate device and does not involve AI/ML performance testing. Therefore, many of the requested elements for AI/ML device studies are not applicable.

Here's an analysis based on the provided text, highlighting which sections are not relevant to this type of submission:

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

Not applicable in the context of an AI/ML device's performance through a diagnostic or predictive study. This submission is for a physical medical device (nerve guide matrix) and its performance is evaluated through material properties, biological safety, and equivalence to a predicate device.

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

Not applicable. This is not an AI/ML study involving a test set of data. The "test" mentioned is a viral inactivation study of the device material.

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)

Not applicable. No ground truth establishment by experts for a test set of data is described. The viral inactivation study uses laboratory measurements and established protocols.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable. The "truth" in this context is the efficacy of the viral inactivation process, measured by accepted scientific methods in a laboratory setting.

8. The sample size for the training set

Not applicable. There is no training set for an AI/ML algorithm.

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

Not applicable.

Information Relevant to the K163457 Submission of the NeuraGen® 3D Nerve Guide Matrix:

The submission focuses on demonstrating substantial equivalence to a predicate device (K130557) and ensuring the safety of the device material.

Acceptance Criteria and Reported Performance (from the document):

Study Details Related to the Viral Inactivation Test:

• Sample Size Used for Test Set: The document mentions "a validated scaled down process that is representative of all Integra LifeSciences Corporation's collagen products." This implies a representative sample of the material was used for the viral inactivation study. The exact number of samples for the study is not specified in the provided text.
• Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by the manufacturer or a contract research organization.
• Ground Truth Establishment: The "ground truth" for viral inactivation is established by internationally recognized standards (ISO 22442-3) and regulatory guidance, using established laboratory methods to measure viral titers before and after processing.
• Qualifications of Experts: Not specified, but personnel conducting such studies would be trained in virology and laboratory safety protocols.

Conclusion stated in the document:

The NeuraGen® 3D Nerve Guide Matrix is substantially equivalent to the current marketed device (NeuraGen® 3D Nerve Guide Matrix, K130557). The viral inactivation study's results do not change the intended use or fundamental scientific technology of the device and do not raise new issues of safety or effectiveness.

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NeuraGen® 3D is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

NeuraGen® 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve discontinuities. NeuraGen® 3D Nerve Guide Matrix provides a protective environment for peripheral nerve repair after injury, and is designed to isolate and protect the nerve and to create a conduit for axonal growth across a nerve gap. NeuraGen® 3D is composed of bovine Type I collagen conduit and a porous inner matrix comprised of collagen and glycosaminoglycan (chondroitin-6-sulfate). When hydrated, NeuraGen® 3D Nerve Guide Matrix is an easy to handle, soft, pliable, non-friable, collagen conduit containing a porous three-dimensional matrix. NeuraGen® 3D Nerve Guide Matrix is supplied sterile, non-pyrogenic, for single use in a variety of sizes.

The provided document is a 510(k) Summary for the NeuraGen® 3D Nerve Guide Matrix. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance study. Therefore, much of the requested information (like sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or not detailed in this regulatory document.

However, the document does describe the testing performed to demonstrate substantial equivalence, which serves as the "study that proves the device meets (implicit) acceptance criteria" for regulatory clearance.

Here's an attempt to answer your questions based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices through rigorous testing, primarily bench tests and biocompatibility assessments, and an animal study for efficacy. The "acceptance criteria" here are essentially the 'Pass' results for each test.

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

• Sample Size for Test Set: Not explicitly stated for bench tests. For the animal study, the document mentions "a clinically relevant, critical sized nerve defect model in a rat," but does not specify the number of rats or the design of the study (e.g., number of treatment arms, controls).
• Data Provenance: Not specified, but likely from testing conducted by or for Integra LifeSciences Corporation in a laboratory setting. No information on country of origin or retrospective/prospective nature is given beyond being a "study." Given it's an animal study, it would be prospective in nature.

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

Not applicable. This is a medical device for physical repair, not an AI/diagnostic device that relies on expert interpretation for ground truth. The "ground truth" for these tests are objective measurements (e.g., diameter, chemical concentration) and biological responses (e.g., cell viability, animal health markers).

4. Adjudication method for the test set

Not applicable, as the tests are primarily objective measurements or standard biological assays rather than subjective interpretations 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 nerve guide matrix, not an AI diagnostic or assistance tool.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The "ground truth" for the various tests includes:

• Bench Tests: Objective physical measurements (e.g., inner diameter, pore diameter), chemical analyses (e.g., enzyme digestion, formaldehyde residue), and material properties.
• Biocompatibility Tests: Standard biological assays with established endpoints (e.g., cell lysis, dermal sensitization, systemic toxicity, mutagenicity, pyrogenicity) as defined by ISO 10993 and other relevant standards.
• Animal Study: Implied physiological outcomes and nerve regeneration specific to the "clinically relevant, critical sized nerve defect model in a rat."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI models that require training sets.

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

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

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