Search Results

The AHP300P is intended to be used as an electrically controlled emergency ventilator that requires an external compressed gas source. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway. The ventilator is intended for use on patients weighing greater than 5kg (11 lbs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. 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.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "AHP300P Emergency Portable Ventilator." This letter grants market clearance based on substantial equivalence to a predicate device and details the product name, regulation number, regulatory class, and product code.

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request for this information based on the provided input. This document is a regulatory clearance letter, not a detailed performance study report.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

Ask a specific question about this device