(50 days)
This device is intended to be used for the prescribed treatment of malocclusions by dentists.
Not Found
The provided text is an FDA 510(k) clearance letter for a device called "Facebow" (K980195). This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
The information you are asking for would typically be found in the 510(k) submission itself, or in supporting documentation, but it is not present in this clearance letter.
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.