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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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Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Collagen Nerve Wrap is a resorbable collagen matrix that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Collagen Nerve Wrap is designed to be an interface between the newe and the surrounding tissue. When hydrated, Collagen Nerve Wrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows Collagen Nerve Wrap to be spread open for easy placement over the injured nerve. The resilience of the Collagen Nerve Wrap allows the product to recover and maintain closure once the device is placed around the nerve. Collagen Nerve Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and in double peel packages.

This document is a 510(k) summary for a medical device called "Collagen Nerve Wrap." The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through a typical clinical trial with acceptance criteria and comparative studies as one might find for a novel drug or a high-risk device.

Therefore, the information you're requesting regarding acceptance criteria, specific study details (sample size for test set/training set, ground truth establishment, expert involvement, MRMC studies, standalone performance), and effect sizes of AI assistance is not typically found in a 510(k) submission for a device like this, as it's not a diagnostic AI device or a device requiring extensive clinical performance measures against predefined metrics.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, materials, and safety/biocompatibility testing.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not included:

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

This type of table is not applicable here. The submission does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) that would be typically seen for diagnostic devices or AI algorithms. Instead, the "effectiveness" is assessed by demonstrating that its characteristics meet design requirements and comparing it to predicate devices.

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

• Test Set Sample Size: Not applicable/provided in the context of typical clinical performance testing as would be requested for an AI diagnostic device. The "test set" here would refer to the animal study and various in vitro and in vivo biocompatibility tests. No specific sample sizes for these individual tests are provided, nor are details on data provenance (e.g., country) or study design (retrospective/prospective) for these tests within this summary.
• Data Provenance: Not specified for the animal study or biocompatibility 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)

Not applicable. This device is a resorbable collagen matrix for nerve protection, not a diagnostic tool requiring expert interpretation or "ground truth" establishment in the way an imaging AI algorithm would.

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

Not applicable. As above, no adjudication method for establishing ground truth is mentioned or relevant for this type of device submission.

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. A MRMC study is relevant for diagnostic imaging devices, especially those incorporating AI. This device is a surgically implanted collagen wrap; therefore, an MRMC study is not relevant or reported.

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

Not applicable. This is not an algorithm or AI device.

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

Not explicitly defined as "ground truth" in this context. For a device like this, "ground truth" would be inferred from the successful completion of biocompatibility tests and the in vivo animal study demonstrating appropriate physiological responses and nerve protection that are comparable to predicate devices. This isn't a diagnostic scenario where a "truth" needs to be established through expert consensus or pathology.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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

Not applicable. This device does not involve a "training set" or a ground truth established in the context of machine learning.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" demonstrating the Collagen Nerve Wrap's safety and effectiveness (and thus, its substantial equivalence) consisted of:

• Biocompatibility Testing: The device underwent and passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. These are standard tests designed to assess the biological response to medical devices in contact with the body.
• Animal Study: The submission mentions "The results of an animal study" as contributing to the conclusion of safety and substantial equivalence to its predicates. No specific details about the animal model, study design, or outcomes are provided in this summary.
• In Vitro Product Characterization Studies: These studies would have evaluated the physical and chemical properties of the Collagen Nerve Wrap to ensure it meets its design specifications (e.g., hydration properties, porosity, resilience, degradation profile).
• Comparison to Predicate Devices: The core of the 510(k) submission is the comparison to legally marketed predicate devices (Collagen Nerve Cuff, NeuraWrap™ Nerve Protector, FASTUBE™ Nerve Regeneration Device). The Applicant states that Collagen Nerve Wrap and its predicates have the same technological characteristics, including intended use, design, materials, material characterization, form, and sizes. This forms the basis for the claim of "substantial equivalence."

Conclusion:

The Collagen Nerve Wrap received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices through an animal study, in vitro product characterization, and in vitro and in vivo biocompatibility testing, rather than through a clinical trial with predefined performance acceptance criteria typical for diagnostic or AI-driven medical devices.

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