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The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.

The provided text is a 510(k) summary for the device ENDOFLOW II – Irrigation, Warming and Suction System. It outlines the device's intended use and compares its technological characteristics and functions to predicate devices to establish substantial equivalence.

However, the document does not contain specific details about acceptance criteria, reported device performance figures, sample sizes, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.

The "H. Performance Data" section merely states: "Performance testing have been executed to validate the performance and safety of the devices. Verification and validation activities were conducted to establish the performance and safety characteristics of the ENDOFLOW® II. The results of these activities demonstrate that the ENDOFLOW® II is safe and effective when used in accordance with its intended use and labeling." This is a general statement and does not provide the requested detailed information about the study or its outcomes.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, and data provenance based on the provided text. The document confirms that performance testing was performed and that the device was found safe and effective, but it doesn't offer the detailed evidence of that testing.

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