(185 days)
The ComPAS software is intended to operate with the ScreenStar pneumotachograph spirometer, Morgan Transflow Test PFT System and the Morgan Transfer Test Benchmark PFT System. ComPAS uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS also utilizes gas analyzer readings from the Transflow Test and Transfer Test Benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.
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This document is an FDA 510(k) clearance letter for the ComPAS Software, a diagnostic spirometer. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain the detailed study information requested in the prompt.
Therefore, I cannot provide the specific answers to your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text. The letter only indicates that a premarket notification was reviewed and found to be substantially equivalent.
To answer your questions, I would need access to the actual 510(k) premarket notification submission for K021200, which would typically include the performance testing and validation data.
§ 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).