(151 days)
Intraoral dental x-ray machine, wall mounted system that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Sanko dental intaoral x-ray series 70 model_W1070-P
I apologize, but the provided text from the FDA 510(k) K972921 for the Sanko Dental Intraoral X-Ray Series 70 Model W1070-P does not contain any information regarding acceptance criteria, device performance metrics, or study details as outlined in your request.
The document is a clearance letter stating that the device is substantially equivalent to a pre-amendment device and outlines regulatory compliance information and contact details. It does not include:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test or training sets.
- Details on expert involvement, adjudication methods, or ground truth establishment.
- Any mention of multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot fulfill your 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.