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The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

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Based on the provided document, the "Single Patient EEG/EP Cup Electrode" received 510(k) clearance (K032278) from the FDA on March 5, 2004. This document is a clearance letter and an "Indications for Use" statement, not a detailed study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the device demonstrated that it is as safe and effective as a device already on the market. However, the details of the testing performed to demonstrate this substantial equivalence are not present in this document.

To answer your request, an extensive search for the 510(k) premarket notification (K032278) and its supporting documentation would be required. This usually involves reviewing the full submission made by Ambu, Inc. to the FDA, which is typically not publicly available in this level of detail without a Freedom of Information Act (FOIA) request.

Therefore, I cannot provide a table of acceptance criteria and reported device performance and other study details based solely on the provided FDA clearance letter and Indications for Use.

The document only confirms:

• Trade/Device Name: Single Patient EEG/EP Cup Electrode
• Regulation Number/Name: 21 CFR 882.1320, Cutaneous electrode
• Regulatory Class: II
• Product Code: GXY
• Indications For Use: The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring, and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
• Predicate Device: Not explicitly named in this document but would have been part of the 510(k) submission.

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