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Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

New Deantronics, Inc. Model SB 312 Disposable Hand Switching Pencil, Rocker Switch, two piece.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Disposable Hand Switching Pencil, Rocker Switch Two Piece." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory class and product code.
• Listing the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
• Stating the intended use of the device.

Therefore, I cannot provide the requested information based on the input text.

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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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