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510(k) Data Aggregation
(219 days)
THE MOSES ELITE APPLIANCE
The Moses Elite appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea.
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This document is primarily an FDA 510(k) clearance letter for "The Moses™ Elite Appliance". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to regulatory clearance, not the detailed results of a performance study.
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