(442 days)
The Acuteventilator is a pumping apparatus of the bellows type, which is adapted for artificial respiration of a distressed person having temporarily no ability to breath by him/herself.
a pumping apparatus of the bellows type, which is adapted for artificial respiration
The provided text is a 510(k) summary letter from the FDA regarding a device named "Acuteventilator," which is a manual emergency ventilator. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/Software as a Medical Device (SaMD) submission.
This document is primarily concerned with the FDA's decision of substantial equivalence of the Acuteventilator to a legally marketed predicate device, falling under the regulatory framework for medical devices (specifically, Class II). It confirms that the device can be marketed in the US.
Therefore, I cannot provide the requested information from the given input. The requested details (acceptance criteria tables, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) are standard for the evaluation of AI/SaMD, but are not applicable to the type of device and regulatory communication presented here.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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).