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The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward. The ApnoDent® design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort. The ApnoDent® appliance consists of upper and lower interlocking, customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user.

The provided text is a 510(k) Summary for the ApnoDent Appliance. It outlines the device description, indications for use, and a comparison to predicate devices, but it does not contain the specific information required to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning device study.

The document is a traditional medical device submission, focusing on material composition, mechanism of action, and comparison to existing non-AI devices. There is no mention of an algorithm, AI, machine learning, or any study involving a test set, ground truth experts, MRMC studies, or standalone performance of an algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving an AI device's performance from this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: Reducing nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
• Technological Characteristics: Customized oral device with upper and lower trays, interlocking system, made from standard orthodontic acrylics and wires, and using screw adjustment for mandibular advancement.
• Performance: The document states that a "biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s)." This indicates the "acceptance criteria" likely pertained to material safety and function, not AI performance metrics.

To answer your specific questions, I would need a document detailing an AI/ML clinical validation study.

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