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The Apinator 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 a 510(k) clearance letter for the Apinator™ device and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria. The letter primarily confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices, based on its intended use as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea in adults 18 years and older.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, or standalone performance) from this particular document. This type of information is typically found in the 510(k) submission itself, including summary reports or clinical study sections, which are not provided here.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. 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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The Moses™ 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.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "The Moses™ Appliance". It is a regulatory document and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulations the manufacturer must comply with.
• Stating the intended use/indications for the device.

Therefore, I cannot provide the requested information based on the given input.

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