(549 days)
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.
The provided text describes the regulatory clearance for the NeoNatalie Resuscitator and includes a comparison to a predicate device, as well as general information about testing performed. However, it does not contain the detailed clinical study information typically provided when discussing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.
The NeoNatalie Resuscitator is a mechanical medical device (manual resuscitator), not an AI/ML device, and therefore the specific questions regarding test sets, training sets, ground truth, expert adjudication, and MRMC studies are not directly applicable in the way they would be for an AI/ML diagnostic or predictive tool.
Based on the provided text, here's an attempt to answer the questions, highlighting where the information is not directly available or applicable:
1. A table of acceptance criteria and the reported device performance
The document frames the "acceptance criteria" and "device performance" in terms of compliance with international standards and functional requirements for a manual resuscitator, rather than traditional clinical performance metrics like sensitivity or specificity for an AI algorithm.
| Acceptance Criteria (Defined by Standards/Functional Requirements) | Reported Device Performance (NeoNatalie Resuscitator) | Predicate Device Performance (Ambu® Mark IV Baby Resuscitator) |
|---|---|---|
| Expiratory Resistance |
§ 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).