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510(k) Data Aggregation
(219 days)
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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