(60 days)
The OS1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics.
The OS1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit. The OS1000C is a Panoramic, Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit.
The input describes a 510(k) notice for the Trophy Radiologie Panoramic Orthoslice OS1000 series, which are dental X-ray devices. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a standard FDA 510(k) clearance letter and the "Indications for Use" statement from the manufacturer. These documents typically confirm that a device is substantially equivalent to a legally marketed predicate device but do not detail the specific studies, metrics, or performance data used to demonstrate that equivalence.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.