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The PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds.

The PulmoTrack Model 1010 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in a pulmonary function testing environment when there is a need to perform an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The PulmoTrack is a computer based electronic stethoscope that utilizes up to five contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes the PulmoTrack Model 1010 device and its substantial equivalence to predicate devices, along with its indications for use. However, it does not include details about acceptance criteria, specific studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

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