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The Millenium Anti-Snoring Device is indicated for use in the treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.

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The provided FDA 510(k) summary for the Millenium Anti-Snoring Device explicitly states that the device is being cleared as "substantially equivalent" to legally marketed predicate devices. This type of clearance generally means that the submission does not typically include a detailed clinical study demonstrating the device meets specific performance acceptance criteria as would be required for a novel or high-risk device. Instead, the focus is on showing similarity to existing products.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed training set information.

The core information provided is:

• Device Name: Millenium Anti-Snoring Device
• Intended Use: Treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.
• Regulatory Status: Class II, regulated under 21 CFR 872.5570 for Intraoral Devices for Snoring and Intraoral Devices For Snoring And Obstructive Sleep Apnea.
• Clearance Type: 510(k) substantial equivalence rather than a PMA (Premarket Approval) which would require more extensive clinical evidence.

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