(206 days)
The Neurotube is intended for single use in patients with an injury to a perioheral news, in which the nerve gap is more than or equal to 8 mm but less than or equal to 3 cm. The time in which the nerve gap is more than of equal to o min our teen and of injury of the time of exploration of failed primary repair.
The Neurotube is a woven, flexible, polyglycolic acid tube which has been heat treated to achieve a configuration corrugated externally for wall strength. The tube is 2.3 mm in diameter and 4 cm in length.
The provided text describes a Premarket Notification [510(k)] Summary for the Neurotube™ nerve conduit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than setting and proving acceptance criteria for an AI device.
Therefore, many of the requested categories for AI device evaluation (such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document, as it concerns a medical device, not an AI algorithm.
However, I can extract the information relevant to the clinical study conducted for the Neurotube™ and present it in a format that aligns with your request where possible, adapting categories for clarity.
Description of Acceptance Criteria and Study for Neurotube™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Primary Goal: Demonstrate substantial equivalence to predicate devices (silicone nerve cuffs and classic nerve graft repairs). | The study indicated that a single-stage, biodegradable, polyglycolic acid conduit (Neurotube™) can be used as an alternative to a nerve graft or a biodurable nerve tube. |
| Efficacy: Provide an optimal environment for longitudinal nerve axon growth of the peripheral nerve, specifically for nerve gaps ≥ 8mm and ≤ 3 cm. | Sensory evaluations (static and moving sensory discrimination tests) at 3, 6, 9, and 12 months showed equivalent results between the Neurotube™ group and the control (classic end nerve graft repairs) group. |
| Safety: Acceptable adverse event profile. | The only adverse effects reported were delayed healing of a skin closure and skin separation with partial extrusion of the Neurotube. |
| Clinical Advantage (over predicate): Avoidance of a second surgery for removal (due to bioresorbable material). | The Neurotube is fabricated from a bioresorbable material, in contrast to nonresorbable silicone, thus precluding the need for a second surgery. (This is a design characteristic rather than a direct clinical performance metric, but it supports the "alternative" claim). |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Total subjects: 98
- Total nerve reconstructions evaluated: 102
- Control group (classic end nerve graft repairs): 56 reconstructions
- Neurotube™ group: 46 reconstructions
- Data Provenance:
- Country of Origin: United States
- Study Type: Clinical trials, conducted prospectively over a period of three and a half years.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number or qualifications of experts involved in performing or interpreting the sensory evaluations. It indicates "medical professionals" would have performed these, but specific details are not provided.
4. Adjudication method for the test set
- The document does not mention a specific adjudication method beyond the direct comparison of sensory evaluation results between the two groups.
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 was a clinical trial for a physical medical device (nerve conduit), not an AI-based diagnostic or assistive tool. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This was a clinical trial for a physical medical device.
7. The type of ground truth used
- Clinical Outcomes/Functional Assessment: The "ground truth" or primary endpoints were clinical sensory evaluations (Static and moving sensory discrimination tests) at defined intervals (3, 6, 9, and 12 months) and the occurrence of adverse events. The comparison was against established surgical techniques (nerve grafts).
8. The sample size for the training set
- Not Applicable. This was a clinical trial for a physical medical device. There was no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. As there was no AI training set, this question is not relevant.
§ 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).