(83 days)
The Mirage Micro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Micro is: - to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. - to be used for single-patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a medical device (Mirage Micro™). It does not contain the information required to answer your prompt.
The document is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and reporting requirements.
Specifically, the document does NOT include any of the following:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes for test sets, data provenance, or training sets.
- Details about expert involvement, ground truth establishment, or adjudication methods.
- Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested information based on the provided text.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).