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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.

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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.

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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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The MCV100 and MCV100-B are intended to be used as an electrically controlled, electrical / gas powered emergency ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the MCV100 Ventilator and MCV100-B Ventilator. This type of document does not contain the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was approved based on its similarity to existing, approved devices, not necessarily on a detailed study proving its performance against specific acceptance criteria as you've outlined.

Therefore, I cannot extract the requested information from this document. It does not describe a study involving performance metrics, expert adjudication, or AI components.

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The EPV100 is intended to be used as an electronically controlled gas powered emergency ventilator, which 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 20kg (44 lbs). This ventilator is intended to be used in the environments associated with emergency medical services (EMS), interhospital transport and hospital facility usage.

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I am sorry, but the provided text does not contain the information required to formulate an answer about acceptance criteria, study details, and device performance. The document is a 510(k) clearance letter from the FDA for a portable ventilator, and it primarily discusses regulatory approval, not device performance or study specifics.

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The Autovent 4000 is a powered emergency transport ventilator, which is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway.

Autovent 4000

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Autovent 4000." It primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and regulatory compliance.

Unfortunately, the document does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment. The letter is a regulatory approval document, not a scientific study report.

Therefore, I cannot extract the requested information from the provided text.

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