(362 days)
The spirometer (Air Smart Extra) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a spirometer. It confirms the device's substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).