(170 days)
The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema.
This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.
The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.
I am sorry, but the provided text does not contain the information requested regarding acceptance criteria or a study that proves the device meets those criteria for the "TrueZone Peak Flow Meter™".
The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a legally marketed predicate device. It confirms the device's classification, product code, and indications for use. However, it does not detail the specific performance acceptance criteria used in the substantial equivalence determination or provide a summary of any study demonstrating the device's performance against such criteria.
Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).