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The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A ) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.

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This document is an FDA 510(k) clearance letter for the NERVEPACE ViewScope Model 200VS. It confirms the device's substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based only on the provided text. The document is strictly an approval letter, not a performance study report.

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