(309 days)
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.
| Parameter | Acceptance Criteria (Implied by equivalence & safety) | Reported Device Performance |
|---|---|---|
| Expanded Indication Performance (Pain Reduction for Neuromas) | Substantially equivalent to Silastic® Nerve Cuff and clinically significant improvement over excision-only for pain reduction in foot neuromas. | 93% success rate of reducing pain for the treatment of neuroma in the foot. Met substantial equivalence to predicate and showed significant improvement over control group in a literature review/meta-analysis. |
| Non-clinical Physical Properties (Suture Strength, Kink Resistance, Permeability, Hydrothermal Transition Temperature) | Equivalent to predicate device (Collagen Nerve Cuff K012814). | Characterization test results "equivalent to those of the predicate device." |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Genotoxicity (Bacterial Reverse Mutation, Mouse Lymphoma, Mouse Micronucleus), Pyrogenicity, Muscle Implantation, Subacute/Subchronic/Chronic Toxicity) | Pass all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. | Non-cytotoxic, Non-sensitizer, Non-irritant, Non-toxic (acute, subacute, subchronic, chronic), Non-mutagenic, Non-pyrogenic. |
| Viral Safety | Ensure viral safety. | Viral inactivation studies performed to ensure viral safety. |
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.
§ 882.5275 Nerve cuff.
(a)
Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).(b)
Classification. Class II (performance standards).