(314 days)
Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.
The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.
Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "SPIROBANK" Portable PC Based Spirometer. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the letter does not contain any information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study details (MRMC or standalone).
Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval, not a technical study report.
§ 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).