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The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.

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I am sorry, but the provided text is a regulatory clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input. The document primarily focuses on:

• Device Name: Solar Neuro Module
• Regulation Numbers and Names: Specifies its classification as an Evoked response electrical stimulator, Nerve conduction velocity measurement device, and Urodynamics measurement system.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.
• Indications For Use: Electro-physiological testing of pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
• Prescription Use: Confirms it's a prescription-only device.

The letter advises the manufacturer on regulatory compliance but does not detail the technical performance studies.

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