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The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.

The MaxAir™ Nasal Dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing.

The provided documents are a 510(k) clearance letter and an Indications for Use statement for the Maxair Nasal Dilator System. These documents confirm that the device has received FDA clearance, but they do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the input provided. The acceptance criteria and study details would typically be found in the 510(k) submission summary or a separate performance study report, which is not included here.

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