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"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.

"MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR)

The provided text is a 510(k) clearance letter from the FDA for a medical device called "miniMAX" Peak Flow Meter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text.

The document primarily focuses on:

• The FDA's decision of substantial equivalence for the "miniMAX" Peak Flow Meter.
• The regulatory classification of the device (Class II).
• General controls and potential additional controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the device: "measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma."

To answer your questions, I would need a different document, such as the actual 510(k) summary or the premarket notification submission itself, which would detail the performance data and testing conducted for the device.

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