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Electrosurgery accessory. Patient return electrode conductor cable for use with the Valleylab E7509 and similar return electrode monitor compatible patient return electrodes that do not have integral cords.

Return Electrode Clamp Shell Cord

This document is a 510(k) premarket notification from the FDA, confirming substantial equivalence for a medical device. It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the 510(k) submission itself, not in the FDA's decision letter.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and indications for use.

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