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1. Quiet Night This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
2. Quiet Night MA This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. This appliance is intended for use when the Quiet Night is ineffective.

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I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device "Quiet Night Sleep Appliance" and "Quiet Night MA Sleep Appliance" has been found substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Trade/Device Name: Quiet Night Sleep Appliance, Quiet Night MA Sleep Appliance
• Regulation Number: 872.5570
• Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea
• Regulatory Class: IIProductName: LQZ
• Indications For Use:
  • Quiet Night: Treatment of mild to moderate obstructive sleep apnea.
  • Quiet Night MA: Treatment of mild to moderate obstructive sleep apnea, intended for use when the Quiet Night is ineffective.

However, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This kind of detailed performance data is typically found in the 510(k) submission itself, which is not fully included in this document. The provided text is the FDA's decision letter, not the full submission or a detailed study report.

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