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The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.

Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

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The provided FDA 510(k) summary for K060374, regarding the REFA Physiological Amplifier, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a letter from the FDA determining that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines the regulatory classification, general controls, and compliance requirements.

Therefore, I cannot provide the requested information from the given input. The requested details such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not present in this regulatory correspondence.

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