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Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.

The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit uses the common 'boil-and bite' technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process, the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. The product is non-sterile and provided in a sealed box with instructions.

The provided text is a 510(k) Summary for the Snore Bandit Anti-Snoring Appliance. It discusses the device's characteristics, comparison to predicate devices, and justification for substantial equivalence. However, it explicitly states, "No clinical testing was performed in association with this submission."

Therefore, I cannot provide the requested information about acceptance criteria or supporting studies because this document indicates that no such studies were conducted for the Snore Bandit device itself to demonstrate efficacy.

The document focuses on establishing substantial equivalence to legally marketed predicate devices based on similarities in design, materials, intended use, labeling, and technological characteristics, rather than direct performance testing of the Snore Bandit device.

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