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This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of

1. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
2. nerve locating using invasive electrodes/neeldes (not supplied)

The STIMPOD NMS400 is a battery powered peripheral nerve stimulators that can be used for

• nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
• nerve locating using invasive electrodes/needles (not supplied)
  The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
  The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.

The provided text (K093591) is a 510(k) summary for a medical device (STIMPOD NMS400 Nerve Stimulator). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for clearance in the US. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information. The sections you asked for, such as sample size for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are typically part of a comprehensive clinical study report, which is not included in this 510(k) summary.

In summary, based on the provided text, the device's acceptance criteria and any study demonstrating their fulfillment are not described.

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