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The RAPHAEL ventilator is a continuous ventilator designed for ventilation of adult, pediatric, and infant patients weighing between 5 and 200 kg, The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator is intended for use in a hospital or hospital-type facility, including use at a patient bedside or for intra-facility transport, provided compressed gas is supplied.

The RAPHAEL is an microprocessor controlled critical care ventilator system. RAPHAEL supplies mandatory or spontaneous breaths with the preset oxygen concentration to provide continuous ventilation for adult, pediatric, and infant patients weighing between 5 and 200kg. It is powered by AC with a battery backup to protect against power failure or unstable power and to facilitate intrahospital transport. The user interface consists of a LCD-display, a display panel keyboard to open windows, and central rotary dial knob (press-and-turn element) for selecting, setting, and confirming inside the window. The user provides inputs to the RAPHAEL microprocessor system through the keys and the press-and-turn element. RAPHAEL provides audible and visual patient-related, and ventilator-related alarms. Accessories to connect RAPHAEL to the patient airway opening are the same as for GALILBO, found substantially equivalent in the 510(k) file number K001686.

The provided text is a 510(k) summary for the RAPHAEL ventilator. It describes the device, its intended use, and states its substantial equivalence to other legally marketed devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

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