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The intended device measures a patient's peak expiratory flow rate liters/minute.

The Besmed Peak Flow Meter is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The proposed device can be used to measure PEF by tracking day-to-day changes in breathing patterns.

The provided document is a 510(k) Summary for the Besmed Peak Flow Meter, seeking clearance from the FDA. It details the device's characteristics, indications for use, and a comparison to a predicate device, as well as non-clinical testing performed to demonstrate substantial equivalence.

However, this document does NOT contain information about an AI/ML-driven medical device, nor does it describe a study involving human readers, ground truth consensus, training sets, or comparative effectiveness with AI assistance.

The device in question, the Besmed Peak Flow Meter, is a mechanical, hand-held device for measuring peak expiratory flow. The performance testing discussed relates to device accuracy, repeatability, and physical durability (e.g., aging, drop test), which are standard for such mechanical instruments.

Therefore, I cannot extract the information required by your prompt because the document does not pertain to the type of device or study you are asking about (i.e., an AI/ML device study with human-in-the-loop analysis).

To answer your request, I would need a document describing the clearance or approval of an AI/ML medical device, which would include details about its acceptance criteria, ground truth establishment, training and test data, and potentially human reader studies.

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