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The Alice® 4 System is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.

polysomnographic system that is intended to record, display, and print EEG and other physiological information

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Alice® 4 System, an electroencephalograph (EEG). This document primarily serves as an administrative notice of substantial equivalence. It does not include the information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the FDA found the device to be as safe and effective as a device already on the market, but the clearance letter itself doesn't contain the specific technical study details that would typically be found in the 510(k) submission itself or related publications.

Therefore, I cannot provide the requested table and study details based on the given text.

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