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The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is an FDA 510(k) clearance letter for the "Advantage™ Nasal Mask" and an "Indications for Use Enclosure." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a specific study, including sample sizes, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types.
• Information regarding training set size or how its ground truth was established.

The document primarily focuses on the regulatory clearance based on substantial equivalence, rather than detailing the technical studies and their results.

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