(92 days)
VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
VersaWrap Nerve Protector is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment, that starts to absorb after implantation. VersaWrap Nerve Protector is designed to be flexible and conformable for placement on or around a peripheral nerve
The provided FDA 510(k) Clearance Letter for the VersaWrap Nerve Protector outlines the determination of substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a study proving the device meets said criteria in the format requested.
The letter focuses on confirming substantial equivalence based on material composition, mechanism of action, and target population, acknowledging a difference in application method (gel vs. sheet). It summarizes non-clinical tests, including an animal study and bench tests, but these summaries do not include quantitative acceptance criteria or detailed performance data.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (What was measured / intended outcome) | Reported Device Performance (Summary from the document) |
|---|---|
| Safety | Demonstrated safe based on no procedure-related complications or device-related premature deaths in the animal study. |
| Efficacy (Providing an interface, permitting normal axonal survival and growth) | The animal study demonstrated the subject device can safely provide an interface between injured nerve and surrounding tissues, without device migration, permitting normal axonal survival and growth in a variety of clinically relevant nerve injury models, performing similar to the predicate device. |
| No Device Migration | Demonstrated in the animal study and included in bench studies. |
| Gel Integrity (Visual inspection, viscosity, cohesivity) | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Handling | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Coverage | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Dimensional and Weight Measurements | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Visual Inspection (General quality/characteristics) | Evaluated in bench studies; performance affirmed to support substantial equivalence. |
| Conformability and Flexibility | Device is described as "flexible and conformable for placement on or around a peripheral nerve." (Not explicitly a performance measure, but a design feature validated in bench tests). |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the animal study, the document states "rats underwent various peripheral nerve injuries." The specific number of rats or nerves tested is not provided.
- Data Provenance: The animal study was "conducted," implying prospective data. The country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document mentions "neurological assessment, and macroscopic and histological evaluation" as methods for evaluating safety and efficacy, which typically involve expert interpretation, but the number or qualifications of these experts are not specified.
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Adjudication method for the test set:
- Not provided.
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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 device is a nerve protector, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (nerve protector), not a software algorithm.
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The type of ground truth used:
- For the animal study:
- Neurological assessment: Clinical observation/evaluation.
- Macroscopic evaluation: Gross anatomical inspection.
- Histological evaluation: Microscopic tissue analysis (pathology).
- For the animal study:
-
The sample size for the training set:
- Not applicable / Not provided. For a medical device like this, the concept of a "training set" typically applies to machine learning models, which is not the case here. The development would involve engineering and material science, potentially with iterative testing, but not a formally defined "training set" in the computational sense.
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How the ground truth for the training set was established:
- Not applicable / Not provided. (See point 7).
Summary of Missing Information:
The provided text from the 510(k) clearance letter gives a high-level overview of the non-clinical testing performed (animal study and bench studies) to demonstrate substantial equivalence. However, it lacks the fine-grained details often found in a full study report, such as:
- Specific quantitative acceptance criteria with numerical targets.
- Precise sample sizes for both animal and bench tests.
- Detailed statistical analyses.
- Information about expert qualifications and ground truth establishment methods beyond the types of evaluations performed.
§ 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).