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SALE AND USE FOR CAUTERIZING AND CUTTING FOR SURGICAL PROCEDURES.

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I am sorry, but the provided text from the FDA 510(k) notification for the Duostar electrosurgical device does not contain the information requested for acceptance criteria and a study proving those criteria.

The 510(k) document primarily focuses on:

• The device's trade name, regulatory class, and product code.
• The finding of "substantial equivalence" to a predicate device.
• General regulatory information, responsibilities of the manufacturer, and contact information for further guidance.
• The indications for use for the device.

There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds), details of a study that evaluated the device's performance against such criteria, sample sizes, expert qualifications, ground truth methods, or any information about AI or human-in-the-loop studies.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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