(218 days)
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.
Not Found
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.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).