(117 days)
The Nerve Capping Device is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
The Nerve Capping Device is a sterile biodegradable nerve cuff composed of the bioresorbable copolyester poly(DL-lactide-s-caprolactone). It is a tubular device with one open end and one sealed end which functions as a cap, isolating the nerve end. The capping device prevents dislocation of the stump by pulling the nerve end into the tube and suturing in the nerve within the cap. Consequently, the end of the cap will be sutured to surrounding tissue. One hole at the sealed end of the tube allows easy fixation with a suture to the surrounding tissue. The size of the product is 3cm in length, and is available in different diameters for different sized nerves. The Nerve Capping Device is sterilized in a pouch package. The device is single-use, cannot be re-sterilized, and is a prescription product.
The provided text describes a 510(k) premarket notification for a medical device called the "Nerve Capping Device." This FDA document focuses on establishing substantial equivalence to previously cleared devices rather than a standalone clinical study demonstrating the device's absolute effectiveness or performance against specific acceptance criteria in a clinical setting.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies generally does not apply to this type of regulatory submission in the way you've outlined for algorithms or diagnostic tools.
However, I can extract and present the performance data provided in the document, which primarily consists of biocompatibility and other physical/mechanical testing, and reframe it to best fit your request.
Here's an attempt to answer your questions based on the provided text, with clear indications where the requested information is not available:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Nerve Capping Device's substantial equivalence was established through non-clinical performance data, primarily focusing on biocompatibility, physical degradation, usability, and mechanical strength, comparing it to predicate devices. The "acceptance criteria" in this context are implicitly met if the device demonstrates comparable biocompatibility and functional characteristics to existing, legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission seeking substantial equivalence, specific numerical acceptance criteria (e.g., "sensitivity > 90%") for clinical performance are not present. Instead, the "acceptance criteria" are implied by demonstrating that the device meets safety and performance standards generally, and is comparable to predicate devices. The reported "performance" are the results of these non-clinical tests.
| Test Parameter / Implied Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|
| Biocompatibility (Compliance with ISO 10993 for permanent contact device) | Cytotoxicity: No biological reactivity (Grade 0) observed. Conclusion: No cytotoxic potential. |
| Sensitization: No significant evidence of causing delayed dermal contact sensitization. Conclusion: Non-sensitizing. | |
| Irritation: No erythema or edema observed. Conclusion: Non-irritating. | |
| Acute systemic toxicity: Test article did not induce a significantly greater biological reaction than control. Conclusion: Not considered systemically toxic. | |
| Pyrogenicity: Endotoxins not detected. Conclusion: Non-pyrogenic (Endotoxin ≤ 0.6 EU/device). | |
| Hemocompatibility: Hemolysis: 0.0% hemolysis observed. Conclusion: Non-hemolytic. | |
| Hemocompatibility: Prothrombin Time Assay: No adverse effect on prothrombin coagulation time. Conclusion: Compatible with blood. | |
| Implantation/local tolerance: Relatively mild foreign body response. Conclusion: Relatively mild foreign body response. | |
| (Bio)degradation: After 16 months very small fragments of material were found. Conclusion: Biodegradable. | |
| (Sub)acute/subchronic toxicity: No toxic responses observed. Conclusion: No subchronic toxicity. | |
| Genotoxicity: No statistical increase found in mutation frequency. Conclusion: Non-mutagenic. | |
| Carcinogenicity: No significant carcinogenic potential. Conclusion: No significant carcinogenic potential. | |
| EO and ECH residues: EO: ≤0.0016 mg/device; ECH: ≤0.00045 mg/device. Conclusion: Residual levels acceptable. | |
| In vitro degradation (Comparable to predicate, maintain shape integrity for up to 10 weeks, comparable pattern) | The in vitro degradation at 37 °C behavior for Nerve Capping Device is comparable to the predicate NEUROLAC®, and the shape integrity will be intact for up 10 weeks to form a barrier and separate the nerve stump from the surrounding environment. The degradation pattern is comparable to that of NEUROLAC®. |
| Usability (Can be used to cover a nerve end quickly and easily, less invasive, sufficient dimensions, convenient fixation) | Overall result is that the device can be used to cover a nerve end in a fast and easy manner and that the procedure is less invasive than currently used techniques. The range of dimensions is sufficient and the flat tube end with fixation hole was found to be convenient to fixate the device into the tissue. |
| Suture retention strength (Pass acceptance criteria, comparable to NEUROLAC®) | All samples passed the acceptance criteria and are comparable to NEUROLAC® regarding retention forces. The suture retention of a suture placed in the tip section is higher compared to a suture placed in the tube section. |
| Tip dimensional verification (Specified dimensions of the tip met) | All samples passed the acceptance criteria. The dimensions of the tip of the device (closed part) are within the tolerances as specified. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for each individual test (e.g., number of devices tested for suture retention or in vitro degradation) are not provided in this summary. The biocompatibility tests for cytotoxicity, pyrogenicity, and EO residues were conducted for the Nerve Capping Device. Other biocompatibility tests (sensitization, irritation, acute systemic toxicity, hemocompatibility, implantation, degradation, subchronic toxicity, genotoxicity, carcinogenicity) were leveraged from predicate NEUROLAC® data due to identical materials and similar manufacturing processes.
- Data Provenance: Not explicitly stated, but common for medical device testing to be conducted in accredited laboratories. The device developer is Polyganics Innovations BV, located in The Netherlands. The referenced FDA Blue Book Memorandum and ISO standards are international.
- Retrospective/Prospective: These are laboratory and engineering tests, not clinical studies, so the terms retrospective/prospective do not directly apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable. The "ground truth" in this context refers to established scientific methods and standards for biocompatibility, material properties, and physical performance testing (e.g., ISO standards, ASTM methods). These tests yield objective measurements rather than subjective interpretations requiring expert consensus on "ground truth" in the way a diagnostic algorithm might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are typically used in clinical trials or studies where subjective interpretations or ambiguous results require resolution by multiple experts to establish a definitive outcome or "ground truth." The tests reported here are largely objective physical and biological assays.
5. If a multi-reader multicase (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
- This question is not applicable. An MRMC study is designed for diagnostic tools or AI systems to evaluate their impact on human reader performance. The Nerve Capping Device is a physical implantable medical device, not a diagnostic or AI-powered system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The Nerve Capping Device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical performance evaluation is based on established scientific and engineering principles, standardized test methods (e.g., those described in ISO 10993), and comparisons to characteristics of legally marketed predicate devices. This includes objective measurements (e.g., chemical residue levels, degradation rates, force measurements) and observations of biological responses in accordance with validated protocols.
8. The sample size for the training set
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility data from the existing NEUROLAC® devices served as a "leveraged" dataset for comparison, but it's not a training set in the AI sense.
9. How the ground truth for the training set was established
- This question is not applicable for the reasons stated above (no training set for an AI device). The "ground truth" for the leveraged predicate data would have been established through similar standardized non-clinical testing performed at the time of their original 510(k) clearances.
§ 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).