(136 days)
Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity
The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap. The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.
The provided text describes the SaluMedica™ Nerve Cuff and its non-clinical evaluation for a 510(k) submission. It does not contain information about a study involving a device and its acceptance criteria in the way a medical AI/software device would. The tests described are for a physical medical device (a nerve cuff), focusing on its physical and biological properties.
Therefore, many of the requested categories for AI/software device evaluations are not applicable. I will extract the relevant information regarding the non-clinical tests performed for this physical device where possible.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable biocompatibility for use as a permanently implanted device. | Testing completed to verify acceptable biocompatibility. |
| Dimensional Analysis | Dimensions within specified tolerances following electron beam sterilization. | Dimensions were within specified tolerances following exposure to electron beam sterilization. |
| Compression and Rebound | (1) Withstand compressive forces > 0.25N without collapsing. (2) Re-open after removal of sufficient compressive forces to collapse the cuff. | (1) Can withstand compressive forces greater than 0.25N without collapsing. (2) Will re-open following removal of compressive forces. |
| Suture Retention Strength | Sufficient strength to resist suture pull-out under loads exceeding those anticipated in the intended use environment. | Has sufficient strength to resist suture pull-out under loads exceeding those anticipated. |
| Shelf-Life | Maintenance of functional integrity following accelerated aging equivalent to six months of real-time aging. | Maintained functional integrity following accelerated aging equivalent to six months of real-time aging. |
| Simulated Clinical Environment | Device design meets the needs of the user. | The device meets the needs of the patient and physician. |
Based on the provided text, the following information is not applicable as the document describes a physical medical device (nerve cuff), not an AI/software device or diagnostic tool typically evaluated with such metrics:
- Sample size used for the test set and the data provenance: Not applicable. The tests were for physical and biological properties of the nerve cuff, not a dataset.
- 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 refers to established material science and biological standards, not expert consensus on diagnostic images or outputs.
- Adjudication method: 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 concensus, pathology, outcomes data, etc): For a physical device, ground truth would be established scientific principles and measured physical/biological properties, not expert consensus on data interpretation.
- The sample size for the training set: Not applicable.
- 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).