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Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment of FeNO by Vivatmo pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti- inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.

The provided text is a 510(k) summary for the Vivatmo pro device, a breath nitric oxide test system. It focuses on regulatory approval and substantial equivalence and does not contain detailed information about the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the full 510(k) submission, which is not provided.

Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document primarily confirms the FDA's determination of substantial equivalence.

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