(149 days)
The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Solid State X-Ray Imaging Device
This document is a 510(k) clearance letter from the FDA for a medical device called the "ADR Plus SSXI Imaging Device for X-ray Systems." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter itself is a notice of clearance, confirming that the device can be legally marketed based on its substantial equivalence to predicate devices, but it does not detail the specific performance testing or clinical studies typically associated with demonstrating acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need a document specifically describing the performance study, its methodology, results, and predefined acceptance criteria.
§ 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.