(137 days)
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "T-Gear", which is a cervical headgear traction appliance.
While it indicates the device is substantially equivalent to legally marketed predicate devices and states its indications for use, it does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, or ground truth establishment for any test or training sets.
- Details about expert qualifications, adjudication methods, or MRMC studies.
- Results from standalone algorithm performance.
The letter is primarily a regulatory approval document confirming market clearance based on substantial equivalence, rather than a technical report detailing a performance study.
§ 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.