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The Pantino Pro Positioner is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

The Pantino Pro Positioner is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable components. The device functions as a mandibular repositioner, which acts to increase the patients Pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has adjustment mechanisms enabling the amount of mandibular advancement to be set by the dentist or physician at the time of the device fitting. The Pantino Pro Positioner is offered in two model designs. The Pantino Pro "A" has a single interlocking mechanism centrically located on the anterior occlusal surface of the upper and lower arches. This design offers lateral movement of the maxillary and mandible for those patients who require this freedom of motion. The Pantino Pro "B" has dual interlocking mechanisms located parallel to one another on the left and right occlusal surfaces positioned as posterior as possible to maintain maximum protrusion and a comfortable fit for the patient. This model offers vertical adjustment control for those patients who require this dimension of vertical stability.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Pantino Pro Positioner, focusing on its substantial equivalence to predicate devices and its intended use. It does not detail specific performance metrics, clinical trials, or the methodologies that would define and test acceptance criteria for the device's efficacy or safety beyond the general regulatory requirements for substantial equivalence.

Therefore, I cannot populate the requested table and sections with the information about acceptance criteria and a study that proves the device meets them from the given text.

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