(318 days)
The VADI Manual Resuscitator is designed for use as an adjunct to artificial respiration and cardiopulmonary resuscitation. The Resuscitator can be used to ventilate the aphonic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.
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I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Vedi Manual Resuscitator, indicating that it has been found substantially equivalent to a predicate device. It specifies general regulatory requirements and the device's indications for use.
It does not include:
- A table of specific acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on multi-reader multi-case studies or standalone algorithm performance.
- Training set details.
§ 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).