(419 days)
The Jaeger OXYCON MOBILE pulmonary function mobile test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The OXYCON MOBILE system allows the use of telemetry for the monitoring of metabolic parameters. The OXYCON MOBILE system is intended to use with adults and children over the age of 14 years.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the Oxycon Mobile device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically associated with the rigorous testing and validation of a new AI/medical device. This type of letter is an approval for marketing based on substantial equivalence, not a detailed technical report of the device's performance or a study proving its meeting of specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).