(114 days)
The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.
The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors).
The provided text is a 510(k) clearance letter from the FDA for a dental X-ray device and an associated "Statement of Indications for Use." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is purely administrative pertaining to regulatory clearance.
§ 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.