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The "Quiet Sleeper" is intended to reduce the severity of snoring, and mild to moderate obstructive sleep apnea. Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea.

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I am unable to extract specific acceptance criteria or details about a study from the provided FDA letter. This document is a 510(k) clearance letter, which indicates the device, "The Quiet Sleeper," has been found substantially equivalent to a legally marketed predicate device.

Key points from the document regarding the device and its clearance:

• Device Name: The Quiet Sleeper
• Regulation Number: None (Unclassified)
• Product Code: LRK (Dental)
• Intended Use: To reduce the severity of snoring, and mild to moderate obstructive sleep apnea.
• Basis for Clearance: Substantial equivalence to predicate devices, referencing that "Several studies have shown the effectiveness of oral appliances that position the mandible forward for the treatment of simple snoring and mild to moderate sleep apnea."

Why the requested information is not available in these documents:

The 510(k) clearance process primarily establishes substantial equivalence to a predicate device. While this process may involve presenting data to demonstrate equivalence, the FDA letter itself does not typically detail the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications used to support the equivalence claim made by the manufacturer in their 510(k) submission.

To obtain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria, one would need to refer to the actual 510(k) premarket notification submission (K012142) made by Precision Dental Laboratories, Incorporated, to the FDA. These submissions contain the scientific and clinical data, if any, used to support the claims.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided FDA clearance letter.

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