(11 days)
The Orthophos XGPMS DS/Ceph Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The Orthophos XGPMS DS/Ceph is the neXt Generation in the Orthophos family of digital dental X-ray Systems. Similar to the prior Orthophos PLUS DS/PLUS DS Ceph device, the Orthophos XG "105 DS/Ceph offers digital imaging with or without the optional cephalometric attachment. Both the new and predicate digital imaging systems offer substantially the same panoramic and optional cephalometric imaging programs with the same exposure levels (kV/mA). Modifications resulting in the new device include a new control panel consisting of an EasyPad with a touchscreen graphical user interface and associated buttons, a new sized CCD sensor, artifact reduction on selected programs, additional options for refining image quality, an electromechanical diaphragm controlled by stepper motors with an adjustable filter system, Class I laser light system for head positioning (replaces halogen light source), and a modified scanning technique for the cephalometric imaging.
The provided text is a 510(k) summary for the Orthophos XGPlus DS/Ceph Dental X-Ray System. It does not describe an acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested.
This document is a regulatory submission for premarket notification (510(k)) to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on comparing the new device to existing technology and highlighting improvements, rather than presenting a detailed performance study with explicit acceptance criteria and results.
Specifically, the document states:
- Basis for Substantial Equivalence: "The modified device has the same intended use and principles of operation as the prior Orthophos devices, as well as substantially equivalent technical specifications. The modifications were implemented to improve ease of use and image quality, and do not change the intended use or fundamental scientific technology of the device. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified Orthophos system."
This indicates that Sirona Dental Systems performed validation testing and a hazard analysis to support substantial equivalence, but the details of these tests, including specific acceptance criteria and detailed performance metrics, are not provided in this 510(k) summary.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document focuses on regulatory approval based on equivalence rather than a detailed performance study.
§ 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.