(74 days)
Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.
Not Found
The provided text does not contain detailed information regarding the acceptance criteria of device performance, the study design, or the specific metrics used to demonstrate the device meets those criteria. The document is an FDA 510(k) clearance letter for the Orthopantomograph® OP100D, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document primarily states that the device is intended for "producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures" and has received regulatory clearance based on substantial equivalence. This type of regulatory document does not typically include the technical details of performance studies as specific as those requested in your prompt.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.