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The intended use of the Compass M10 system is to record physiological signals during sleep, scan the signals for abnormalities and represent the count of abnormal events in a form of a summary report. The results of the scan may be manually overwritten or corrected by the physician. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's count of abnormal events. It is not intended for any diagnosis. It is not intended to be a monitor.

The Compass M10 system is intended to be used for adult and pediatric patients.

The Compass M10 system is an ambulatory recording system. It includes a recording device, a signal adapter, respiratory effort sensors, strap system for attaching of recording device to a patient, an USB cable for data download and the Compass application.

The Compass M10 device is a pocket size battery powered digital recorder that incorporates electronics to record and store one night of physiological parameters. It has two respiratory channels for measurement of thoracic and abdominal movements and a built-in body position and actigraph sensor for measurement of body position and movement. It also has an optional oximeter input to measure degree of oxygen saturation of the blood. The Compass application provides the means to prepare the device for recording, download the recorded data, viewing and analyzing the recorded data on a PC.

The provided text (K041724 510(k) Summary) focuses on the device description, intended use, and substantial equivalence to predicate devices for the Compass M10 system. It does not contain information regarding acceptance criteria, device performance studies, or details about test sets, ground truth establishment, expert qualifications, or multi-reader studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions 2 through 9.

The document primarily establishes the device's technical characteristics and intended use for the purpose of a 510(k) submission, confirming its substantial equivalence to previously cleared devices. It does not include the detailed performance study results that would typically contain the information requested.

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