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The ETI Hemostatic Probe is intended for use during endoscopic procedures where electrosurgery is required to cauterize tissue of actual or potentially bleeding sites in the gastrointestinal tract. The device also can be used for irrigation.

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The provided text is a clearance letter for a medical device (ETI Bipolar Hemostatic Probe). It does not contain information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report or clinical trial documentation.

Therefore, I cannot provide the requested information based solely on the provided input. The letter confirms that the device has been found substantially equivalent to a legally marketed predicate device and lists the indications for use. It does not elaborate on the specific tests or studies conducted to demonstrate this equivalence or the performance metrics achieved.

To answer your questions, I would need access to the 510(k) submission itself or a summary of its contents, which would typically describe the testing and performance evaluation.

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