(93 days)
The Neurolac® nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
Neurolac® is designed to be a flexible and transparent resorbable poly(DL-lactide-co-ε-caprolactone) tube to provide a protective environment for peripheral nerve regeneration after injury and to create a conduit to guide axonal growth across a nerve gap.
Neurolac® nerve guides are provided sterile in Tyvek pouch packages and retainer in a variety of sizes.
The Neurolac® Nerve Guide is a medical device designed to assist in the regeneration of peripheral nerves after injury. The device manufacturer, Polyganics BV, submitted a 510(k) premarket notification to the FDA to demonstrate its substantial equivalence to previously marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not specify quantified acceptance criteria (e.g., specific thresholds for suture retention strength or nerve function recovery). Instead, the performance data focused on demonstrating safety and effectiveness through various tests and analyses, indicating that the device performs comparably to predicate devices. The implicit acceptance criteria were that the device's performance data, alongside biocompatibility and comparison to predicate devices, would be sufficient to establish substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device biocompatibility | Biocompatibility testing was performed. Evaluation of the Polyganics Neurolac® Nerve guide based on biocompatibility testing, animal tests, results from literature, and comparison with predicate devices showed it to be safe for implantation. |
| Adequate mechanical properties (e.g., suture retention) | In vitro suture retention testing was conducted. No specific values provided, but the inclusion implies it met internal or comparative standards. |
| Appropriate degradation profile | In vitro degradation testing was conducted. No specific values provided, but the inclusion implies it met internal or comparative standards suitable for nerve regeneration. |
| Support for nerve function recovery | In vivo nerve function recovery was evaluated in an animal model. No specific metrics or statistical results are provided within this summary, but the study implies positive outcomes demonstrating its ability to guide axonal growth and promote regeneration. Performance testing in an animal model provided reasonable scientific evidence. |
| Substantial equivalence to predicate devices in design, technology, and intended use | The Neurolac® Nerve Guide's design, fundamental technology, and intended use are substantially equivalent to Neurotube™ (K983007) and NeuroGen™ Nerve Guide (K011168). This was supported by biocompatibility, mechanical and physical property testing, in vitro degradation testing, and performance testing in an animal model, indicating its safety and efficacy are comparable to the predicate devices. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated for each test.
- For the "In vivo nerve function recovery," it states "an animal model" was used, but the number of animals or specific experimental subjects is not provided.
- For "In vitro suture retention testing" and "In vitro degradation testing," the number of samples or replicates used in these tests is not specified.
- Data Provenance: The studies were conducted by Polyganics BV, a company based in The Netherlands.
- The in vitro tests (suture retention, degradation) are laboratory-based.
- The in vivo test was conducted using "an animal model." The specific type of animal, the location of the animal study, or if it was retrospective or prospective is not detailed, but it would have been a prospective study to evaluate the device's performance.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This is a medical device for nerve repair, and the evaluation did not involve human-in-the-loop diagnostic performance or
expert interpretation of images to establish ground truth in the context of AI/diagnostic device studies. Instead, its performance was assessed through physical, chemical, and biological testing.
4. Adjudication Method for Test Set:
Not applicable. As described above, the study does not involve human readers interpreting data that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a passive nerve guide, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Neurolac® Nerve Guide is a physical medical device, not an algorithm. Its performance is inherent to its physical and biological properties.
7. Type of Ground Truth Used:
The "ground truth" for evaluating the Neurolac® Nerve Guide was established through:
- Direct measurement and observation: For in vitro tests like suture retention and degradation, the "ground truth" was empirical data derived from standardized laboratory tests.
- Biological outcomes: For in vivo nerve function recovery, the "ground truth" would be the observed biological response to the device in an animal model, such as nerve regeneration, functional recovery, and histological assessments. These would be determined by objective measurements and scientific observation in a controlled experimental setting.
- Comparison to predicate devices: The "ground truth" for substantial equivalence was the established performance and safety profiles of the legally marketed predicate devices (Neurotube™ and NeuroGen™).
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning system, so there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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).