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Vivatmo pro-S 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. Measurement of FeNO by Vivatmo pro-S 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 levels. FeNO measurements are to be used as an adjunct to established clinical assessments.

Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older.

Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.

The Vivatmo pro-S system is a automated, non-invasive (in-vitro diagnostic) medical device for professional environment for the quantitative measurement of FeNO (fractional exhaled Nitric Oxide) in human breath.

Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as asthma.

FeNO is recommended by the American Thoracic Society (ATS) in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to airway inflammation [ATS, 2011].

The Vivatmo pro-S device consists of the following main elements:

• Vivatmo pro-S handheld which holds the measuring module with electronics, display and a battery including software to drive the handheld.
• Vivatmo pro Oxycap/Vivatmo me Oxycap, which is a disposable mouthpiece to prepare the exhaled air for the measurement
• Vivatmo pro Level 0, a disposable mouthpiece to facilitate a measurement with 0 ppb FeNO for QC purpose (optional)

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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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