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The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.

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The provided text is a 510(k) premarket notification letter from the FDA to Viasys Healthcare GmbH regarding their FlowScreen device. This document primarily focuses on the regulatory approval process and does not contain detailed information about acceptance criteria or the specific study that would prove the device meets these criteria. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing, but it does not elaborate on the technical performance data or studies that led to this determination.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert involvement from this document. The document confirms the device name, intended use, and regulatory classification but does not provide the technical study data.

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