(255 days)
The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.
The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.
Here's a summary of the acceptance criteria and the study information for the Neurovision Nerve Locator/Monitor Model NV006, based on the provided text:
Acceptance Criteria and Device Performance
| Feature/Criterion | Acceptance Criteria (from NV004/Predicate) | Reported Device Performance (NV006) |
|---|---|---|
| Indications for Use | Per 510(k) (K954601) | Same, plus addition of spinal procedures |
| Digital Display | N/A | Provides electrode impedance readings |
| Firmware | Assembly Language | Same |
| Logical Algorithm | Neurovision proactive nerve location algorithm | Same |
| Stim voltage limit | 38 V | Same |
| Stimulation Output | Max 5mA, 5 steps, constant current | Max 5mA/12 mA, 10 steps, high range by separate cable (0.1mA to 12mA). Lowest setting 0.1mA conforms to ISO 60601-2-40. |
| Stim delivered audio | "Tic-tic" audio alert | Same |
| Stimulation Calibration | None | Accurate within 5% of delivered current |
| EMG | Variable gain | Same |
| Channels | One | Same |
| Electrode off alarm | 4 beep alarm | Same |
| Impedance measure | >15 k fixed alert | Actual measurement with digital display |
| Audio out | Sounder | Speaker |
| Audio mode | Fixed alarms only | Alarms only, raw EMG only, or both (user select) |
| Audio alarm tone | Beep | Same |
| Volume | Variable, no zero | Same |
| Self-test feature | Analog CAP internal | Same |
| Event LED | Present | Same |
| Battery LED | Present | Same |
| Data out | Analog raw EMG out | Serial USB out; raw EMG and status data |
| Data collection | Digital PC oscilloscope | Dedicated digital EMGView oscilloscope software (K102861) |
| Cable Assembly | EMG and Stimulation (low) | Same, plus additional High-Stimulation cable |
| Stimulating Lead Wire | Reusable / user sterilizable wire, disposable sterile | Disposable sterile wire |
| Circuitry | Analog/digital | Same |
| Layout | Thru-hole components | Same, plus surface mount |
| Isolation | Per design | Improved physical isolation; shielding by Opto Isolators |
| High Stim LED | N/A | Activated when High Stim cable in use |
| Power | 20 v AC Power Supply/Charger; not certified | 12 V DC Power Supply/Charger; certified |
| Nerve Location Indication | Detection circuitry always active | Detection circuitry active only during stimulation. Helps prevent false alarms. (This is a change/improvement) |
| Laryngeal Surface electrode – accessory | Accessory sold separately (Cleared through K003745) | Cleared through K003745 |
| Stimulating Hemostat – accessory | Accessory included with System (Cleared through K895676) | Cleared through K895676 |
| Hydrogel Ground – accessory | Accessory sold separately (Cleared through K092744 and K110138) | Cleared through K092744 and K110138 |
| Needle Ground Electrode – accessory | Accessory sold separately (Cleared through K091056) | Cleared through K091056 |
Study Information:
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Sample size used for the test set and data provenance:
- The document states "Preclinical testing verified the design of this device and that all specified requirements were fulfilled." No specific details about the sample size of a test set (e.g., number of patients, cases, or data points) are provided.
- The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned. Given the nature of a 510(k) for a device like a nerve monitor, most "preclinical testing" would likely involve bench testing, animal models, or potentially limited human use studies that are not described in detail here.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the document.
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Adjudication method for the test set:
- This information is not provided in the document.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. The device is a nerve locator/monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of typical MRMC studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "Preclinical testing" mentioned implies standalone testing of the device's functionality. The document highlights various technical specifications and changes from the predicate device that would be subject to such testing (e.g., accuracy of delivered current, impedance measurement, alarm functions, stimulation output). However, no specific details of a formal "standalone" study are provided beyond the general statement.
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The type of ground truth used:
- Given that the preclinical testing verified the design and requirements, the ground truth would likely be based on:
- Engineering specifications and standards: Conformance to ISO 60601-2-40 for stimulation output, accuracy within 5% of delivered current, and other technical requirements.
- Functional verification: The device's ability to accurately provide impedance readings, generate anticipated audio alerts, and stimulate within specified ranges.
- Comparison to predicate device performance: Showing that the NV006 performs at least as well as the NV004 for existing functions and that new functions (like high-stim) meet their design intent.
- Given that the preclinical testing verified the design and requirements, the ground truth would likely be based on:
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The sample size for the training set:
- The device described is a medical instrument (hardware and embedded software) for nerve location and monitoring, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The "logical algorithm" is described as the "Neurovision proactive nerve location algorithm," which is "Same" as the predicate device, implying it is a deterministic, rule-based algorithm rather than a learned model. Therefore, the concept of a "training set" as used for machine learning models does not apply here.
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How the ground truth for the training set was established:
- As explained above, the concept of a "training set" for a machine learning model does not apply to this device based on the provided information.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).