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The IUR Fluid Management System is a system intended to provide liquid distension of the uterus for diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.

The IUR Fluid Management System consists of a microprocessor controlled pump intended to distend the uterus and a monitoring unit designed to monitor the irrigation fluid losses during hysteroscopic procedures. The pump unit functions according to the peristaltic principle. It consists of a power supply, main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active pressure reduction ensures the conformity of the preset nominal pressure value with the actual measured pressure. The pump unit is designed with several alarms to inform the operator in case of an overpressure. The fluid monitoring unit operates with a volume differential measurement to determine the fluid losses remained in the patient. It consists of the following components: display unit, bag holder, bag deflector, carrier plate for the pump unit, scale pole, unit stands pole, weighting unit, container holder, roller base and load controller. The deficit threshold alarm level can be selected by the operator in the range of 0-2000 ml. The IUR Fluid Management System is only functional if the monitoring unit is connected to the pump unit and a specific resectoscope is attached.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The "Performance Data" section (VIII) only states that the device complies with International Standards IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). These are safety and compatibility standards, not specific performance acceptance criteria related to its intended use (liquid distension and fluid loss monitoring).

Therefore, I cannot populate the requested table or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

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