(497 days)
Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.
The Nerve Tape device is composed of a bioabsorbable, extracellular collagen matrix derived from small intestinal submucosa (SIS). Microhooks made of a nickel-titanium alloy (NiTiNOL) are integrated into the nerve contacting side of the SIS for mechanical fixation and apposition of nerve ends. The device is packaged in a dried state and supplied sterile, and is rehydrated prior to use.
The provided text outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Nerve Tape device to predicate devices, rather than a study proving the device meets general acceptance criteria in a comparative effectiveness study with human readers.
However, based on the information provided for the Neve Tape device, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed against these predicate devices and established standards.
| Test / Characteristic | Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate/Standard) | Reported Device Performance |
|---|---|---|
| User handling validation / Ease of Use | Ease of use characteristics substantially equivalent to the predicate device. | The ease of use characteristics of the Nerve Tape device are substantially equivalent to the predicate device (AxoGuard® Nerve Connector). All samples met acceptance criteria. |
| Monotonic tensile strength | Tensile strength substantially equivalent to standard suture for nerve repair. | The tensile strength of the Nerve Tape device is substantially equivalent to standard suture for nerve repair. All samples met acceptance criteria. |
| Dimension Compliance | Compliance with dimensional criteria for all components and assemblies. | Pass |
| Corrosion Resistance (NiTiNOL components) | Meeting ASTM F2129 standards for corrosion susceptibility. | Pass |
| Transformation temperature (NiTiNOL components) | Meeting US FDA Guidance Document "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol" and ASTM F2004. | Pass |
| Magnetic resonance imaging safety and compatibility | Meeting US FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". | Pass |
| Biocompatibility | Established in accordance with ISO 10993-1:2018 for permanent contact (>30 days) implantation across various endpoints. | Biocompatibility endpoints (cytotoxicity, sensitization, acute systemic toxicity, subchronic/chronic systemic toxicity, pyrogenicity, implantation, genotoxicity) were assessed and established with no adverse findings. |
| Sterilization validation | Conformance with ISO 11135:2014 and AAMI TIR28:2016. | Pass |
| EO Residuals | Conformance with ISO 10993-7:2008. | Pass |
| Animal Study (Safety and Effectiveness) | As safe and effective as the predicate device (AxoGuard® Nerve Connector) and nylon suture in repairing peripheral nerve discontinuities. | The studies demonstrated that the Nerve Tape device is as safe and effective as the AxoGuard® Nerve Connector and nylon suture in repairing peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. |
2. Sample sized used for the test set and the data provenance
- User Handling Validation/Ease of Use: "All samples met acceptance criteria." The specific sample size for the rabbit tibial nerve cases is not explicitly stated, but it involved multiple surgeons performing applications.
- Monotonic Tensile Strength: "All samples met acceptance criteria." The specific sample size of cadaveric nerve repairs is not explicitly stated.
- Animal Studies: The study used a rabbit tibial nerve transection model. Specific sample sizes for the number of rabbits or nerve repairs are not given, but evaluations were performed at 4-week or 16-week time points. This is prospective animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- User handling validation/Ease of Use: "Surgeon performance and handling... were assessed for ease of use". The number of surgeons and their specific qualifications are not detailed beyond being "surgeons." They were implicitly the "experts" assessing ease of use.
- Animal Studies: "Outcome measures included macroscopic assessment of the nerve implant sites, muscle weight and girth, and histological assessment of the implant sites and surrounding tissues." These assessments would have been performed by qualified individuals (e.g., veterinary pathologists, histologists), but the specific number and qualifications are not mentioned.
4. Adjudication method for the test set
The document does not describe a formal adjudication method for ground truth in the context of human expert review. The "acceptance criteria" are based on performance metrics against established standards or predicate devices, and internal assessments (e.g., "All samples met acceptance criteria").
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 such MRMC study was performed or described. This submission relates to a physical medical device (Nerve Tape), not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a physical medical device, not an algorithm. Therefore, "standalone algorithm-only performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance was established through:
- Quantitative measurements against standards: For mechanical properties (tensile strength), material properties (corrosion resistance, transformation temperature), and dimensional compliance.
- Compliance with validated protocols: For biocompatibility and sterilization.
- Direct observation and assessment: By surgeons for ease of use.
- Histological assessment and macroscopic evaluation: For the animal study, which serves as a form of "pathology" and direct physiological outcome data.
8. The sample size for the training set
This document describes a premarket notification for a physical medical device. The concepts of "training set" and "test set" are typically used in the context of machine learning (AI) models. While the manufacturer likely conducted internal development and testing during the design phase, the document does not present data in terms of a formal "training set" like one would for an AI algorithm.
9. How the ground truth for the training set was established
As above, the concept of a formal "training set" and its "ground truth" as it applies to AI/ML devices is not relevant to this submission for a physical medical device. The "ground truth" for the various non-clinical and animal studies described were established through standardized test methods, material specifications, and biological evaluations.
§ 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).