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The AHP300 (with internal compressor) is intended to be used as an electrically controlled emergency ventilator. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patient's airway. The ventilator is intended for use on patients weighing greater than 5kg (11 1bs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), inter-hospital transport and hospital facilities usage by qualified, trained personnel under the direction of a physician. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95% relative humidity non-condensing.

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I'm sorry, but this document does not contain the information requested. The provided text is a 510(k) premarket notification letter from the FDA regarding an emergency portable ventilator. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. However, it does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any information related to AI or MRMC comparative effectiveness studies. Therefore, I cannot complete the table or answer the questions based on the provided input.

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