(178 days)
The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording for less than or equal to 10 hours from the cochlear cranial nerves during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.
The DNAP Cranial Nerve Electrode (DNAP electrode) is intended for intraoperative nerve monitoring/recording during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle during surgical procedures. The DNAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System MEE-1000A or MEE-2000 Neural Function Measuring System.
The DNAP electrode is a single patient use, disposable cranial nerve electrode used for recording cranial nerve action potentials. The DNAP electrode may be used for recording the action potentials of cochlear nucleus elicited by auditory stimulation. The user places the electrode on the dorsal cochlear nuclei. Access to the dorsal cochlear nuclei may be through the foremen of Luschka. This potential is called DNAP (dorsal cochlear nucleus action potential), and used to preserve cochlear nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle.
The provided document is a 510(k) summary for the Ad-Tech Medical Instrument Corporation's DNAP Cranial Nerve Electrode. It outlines the device's indications for use and compares its technological characteristics and performance to a predicate device (Cueva Cranial Nerve Electrode K044061) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Requirement | Reported Device Performance and Results |
|---|---|
| Electrical Resistance (from electrode contact to connector) | Pass |
| DNAP electrode Connector compatibility (with monitor equipment) | Pass |
| Electrical continuity and resistance after tensile testing | Pass |
| Electrode separation under tensile test | Pass (No electrode head separation) |
| Electrical continuity and resistance after simulated use (for ≤ 10 hours intraoperative use) | Pass |
| Overall length (dimensional requirements) | Pass |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity) | Performed and deemed acceptable |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test sets used in the performance benches. It refers to "evaluations" and "tests" without detailing the number of devices or trials.
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given these are bench tests for a medical device seeking premarket notification in the US, it's highly likely they were conducted in a controlled lab environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the type of studies presented. The performance tests (electrical resistance, tensile strength, compatibility, biocompatibility) are objective bench tests, not requiring expert human interpretation or "ground truth" establishment in the clinical sense.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the studies described are objective bench tests, not involving subjective human assessment or consensus methods for ground truth adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is an electrode for intraoperative monitoring, not an AI-powered diagnostic tool that assists human readers/interpreters. The focus is on the physical and electrical performance of the electrode itself.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an electrode), not an algorithm or software. Its function is to record signals, which are then interpreted by human clinicians using an external Neural Function Measuring System.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of objective, predefined engineering and biocompatibility standards and specifications. For instance, electrical resistance must fall within a specified range, and tensile strength must meet a certain threshold without failure.
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The sample size for the training set:
- This is not applicable. The device is an electrode, not a machine learning model. Therefore, there is no "training set."
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How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).