(90 days)
The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.
Software for extraoral X-ray units
I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an Indications for Use statement for the "Vipersoft™ (Software for Extraoral X-ray Units)".
This document does not contain any information regarding:
- Acceptance criteria or reported device performance
- Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies) for Vipersoft™.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the study details you've asked for, as this information is not present in 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.