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The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires, intended for use during various types of EEG testing in which only a subset of the full 10/20 electrode sites are required. This cap is NOT intended for use in which a full set of the 10/20 electrode positions need to be monitored, or in which precise localization of the EEG activity is of vital importance such as localization of a seizure focus. The Dream Catcher holds electrodes at the C3, Cz, C4, O1, OZ, O2, A1 and A2 positions.

The Dream Catcher is a headpiece with adjustable mounts for attaching surface electrodes with lead wires.

This is a 510(k) clearance letter from the FDA, dated August 29, 1997, for a device called "DREAM CATCHER." The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, or ground truth establishment that you are requesting. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document submitted by the manufacturer to the FDA. The provided text is solely the FDA's clearance letter.

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