(224 days)
The FREMAP Cranial Nerve Electrodes are designed for intraoperative (=
The device under review is a Facial nerve Root Evoked Muscle Action Potential (FREMAP) electrode. The electrode is used to elicit the muscle action potentials by electric stimulation directly to the facial nerve. It is commonly placed on the facial nerve or facial nerve root at the CP-angle and is used for monitoring (elicit) the muscle action potential response to preserve the facial nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle. The FREMAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System Neuromaster MEE-1000A or MEE-2000
The document provided is a 510(k) premarket notification for a medical device called the "FREMAP Cranial Nerve Electrode." It compares the device to several predicate devices to demonstrate substantial equivalence, rather than presenting a study where the device's performance is measured against acceptance criteria in a clinical or simulated clinical setting.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment cannot be fully provided from the given document.
However, I can extract the performance tests performed to demonstrate substantial equivalence, which serve as a form of acceptance criteria in the context of this 510(k) submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests conducted to establish substantial equivalence. It states that "Test requirements were met or a process monitor is in place to confirm compliance." Specific quantitative results or typical acceptance ranges for these tests are not provided in the document.
| Test | Summary of Requirement | Reported Device Performance |
|---|---|---|
| Electrical Resistance | Measure electrical resistance from the electrode contact to connector. | Met (or process monitor in place to confirm compliance) |
| FREMAP electrode Connector compatibility with monitor equipment | Verify the FREMAP electrode Connector is able to connect to neural function measuring systems (MEE-1000A or MEE-2000). | Met (or process monitor in place to confirm compliance) |
| Electrical continuity and resistance after tensile testing | Verify electrical continuity and resistance properties are met after tensile load was applied to the FREMAP electrode. | Met (or process monitor in place to confirm compliance) |
| Electrode separation under tensile test | Evaluate risk of electrode head separation with a load under tensile test. | Met (or process monitor in place to confirm compliance) |
| Electrical continuity and resistance after simulated use. | Apply a simulated stimulation potential for the 10 hour anticipated duration of intraoperative use. | Met (or process monitor in place to confirm compliance) |
| Overall length | Confirm dimensional requirements are met. | Met (or process monitor in place to confirm compliance) |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Test and Acute System Toxicity) | Evaluations for these specific biological effects of manufactured and sterilized FREMAP Electrodes. | Performed and presumably met, though specific results not listed. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes for any of the performance tests listed. This is not a clinical study but rather a series of engineering and biological safety tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the data is retrospective or prospective. These are lab tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes engineering and biocompatibility tests, not a study requiring expert-established ground truth for device performance in a diagnostic or clinical decision-making context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for the type of tests described.
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, an MRMC comparative effectiveness study was not done. The FREMAP electrode is a passive cranial nerve electrode for monitoring and stimulation, not an AI-powered diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a passive electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests mentioned (electrical resistance, continuity, tensile strength, dimensions, biocompatibility), the "ground truth" would be the engineering specifications and established ISO/ASTM standards for medical device materials and components, and biological safety standards (e.g., ISO 10993 for biocompatibility). The document does not detail these specific standards or criteria, only that the tests were performed and requirements were met.
8. The sample size for the training set:
- This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable as the FREMAP electrode is not an AI/ML device that requires a training set.
In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence through a comparison of technological characteristics and safety/performance testing of the device itself (an electrode), rather than an efficacy study of a diagnostic or AI-powered system involving clinical data and human interpretation. Therefore, many of the requested elements are not relevant or present in this type of regulatory submission.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.