(49 days)
The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators used to provide ventilatory support in confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment. The ventilator is suitable for use in: Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support in the confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital and inter-hospital transport of non-breathing patients.
The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators.
I am sorry, but based on the provided document, the information required to answer your request is not present. The document is an FDA 510(k) clearance letter for the CAREvent CA and CAREvent DRA devices, indicating that the devices are substantially equivalent to legally marketed predicates. It covers regulatory aspects, such as product codes, regulation numbers, and instructions for marketing, but it does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance testing.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case comparative effectiveness study or its effect size.
- Confirmation of whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).