(41 days)
The SURGIS Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.
The SURGIS Nerve Cuff is manufactured from porcine small intestinal submucosa (SIS) and is supplied in nominal tube diameters of 2, 5 and 7 mm, and a nominal length of 5 cm. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Acceptance Criteria and Study for SURGISIS® Nerve Cuff
This document summarizes the acceptance criteria and the studies conducted to demonstrate that the SURGISIS® Nerve Cuff meets these criteria, based on the provided 510(k) summary (K031069).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device is biocompatible | "Outcomes show the device to be biocompatible..." |
| Viral Inactivation | Manufacturing processes adequately disinfect the material | "...manufacturing processes to adequately disinfect the material..." |
| Mechanical Properties: | ||
| - Tensile Strength | Sufficient tensile strength | "...tensile strength to be sufficient..." |
| - Suture Retention Strength | Sufficient suture retention strength | "...as well as suture retention strength..." |
| - Compressive Forces | Ability to withstand compressive forces | "...ability to withstand compressive forces..." |
| In Vivo Performance | Promotes axonal growth and myelination | "...during in vivo use to be associated with a higher degree of axonal growth and myelination as compared to controls." (Comparison to control implies a positive, statistically significant difference or clinical relevance) |
| Substantial Equivalence | Similar to predicate devices in intended use, materials, and technological characteristics, and suitable for nerve cuff repair | "The SURGIS Nerve Cuff is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through in vitro and in vivo testing." and "Outcomes from the evaluation of the SURGISIS® Nerve Cuff provide evidence of its suitability for nerve cuff repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample sizes used for the in vitro or in vivo test sets for the SURGISIS® Nerve Cuff, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "extensive biocompatibility testing, viral inactivation testing, mechanical testing, and assessment of in vivo performance."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for any of the tests conducted. The testing appears to be primarily laboratory-based (biocompatibility, viral inactivation, mechanical) and animal-based (in vivo performance), rather than relying on expert clinical assessment of a test set in the way an AI/CAD system might.
4. Adjudication Method for the Test Set
Not applicable. The types of tests described (biocompatibility, viral inactivation, mechanical, in vivo animal studies) do not typically involve an adjudication method by human experts in the context of establishing a clinical ground truth for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The summary describes a medical device (nerve cuff) and its performance, not an AI or CAD system. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implantable nerve cuff, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the various tests can be inferred as follows:
- Biocompatibility: Established through standardized in vitro and in vivo biocompatibility testing methods, likely involving cellular responses, tissue reactions, and toxicology assessments.
- Viral Inactivation: Established by validated laboratory assays to detect viral agents following the manufacturing process.
- Mechanical Properties (Tensile Strength, Suture Retention, Compressive Forces): Established through standardized engineering and materials testing methods using calibrated equipment.
- In Vivo Performance (Axonal Growth and Myelination): Established through histological analysis, immunohistochemistry, and potentially functional recovery assessments in an animal model, compared to control groups (e.g., empty cuff or direct repair).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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).