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The SleepNet Corporation MiniMe™ 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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The provided document is a 510(k) premarket notification letter from the FDA for a medical device (SleepNet MiniMe™ Nasal Mask). It declares substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, or clinical trials with human subjects.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as an FDA clearance letter based on substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device. It typically doesn't include detailed performance study results that would be found in a Premarket Approval (PMA) application or other regulatory submissions requiring clinical trials.

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