(54 days)
The XIOSPI48 Wall-Module and the XIOSPlus Sensors are intended for acquisition of digital dental intraoral X-ray exposures.
Unit for acquisition of digital dental intraoral X-ray exposures.
The Sirona XIOSPlus Wall-Module is an acquisition device for digital dental intraoral X-ray exposures. It comprises of the XIOSPlus Wall-Module, one or two pluggable solid X-ray sensors and a SIDEXIS Software Plug-in, managing XIOS"108 Wall-Module and Ethernet related tasks, and interfacing SIDEXIS. The XIOS Wall Module is connected via Ethernet to one or more PCs on which the Plug-in and SIDEXIS are running. Operation related information is displayed or signaled through a display or LEDs.
The provided document for the Sirona Dental Systems XIOSPlus Wall-Module is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, the document does not contain the requested information regarding specific acceptance criteria for performance metrics, a study proving the device meets those criteria, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used for performance validation.
The 510(k) summary primarily discusses:
- Device Name: XIOSPlus Wall-Module
- Intended Use: Acquisition of digital dental intraoral X-ray exposures.
- Device Description: It's an acquisition device comprising the Wall-Module, pluggable solid X-ray sensors, and a SIDEXIS Software Plug-in. It connects via Ethernet to PCs running SIDEXIS.
- Predicate Devices: Sirona Wall-Box (K013659) and Schick Computed Oral Radiology System (K072134).
- Basis for Substantial Equivalence: Primarily based on similar overall design, intended use (intraoral exposures), similar image areas, pixel size (identical to one predicate, smaller than another), and higher acquired image matrix/resolution compared to one predicate. Communication methods (Ethernet vs. USB) are noted as a difference.
To answer your specific questions, the document would need to include information from a dedicated performance study report, which is not part of this 510(k) summary.
§ 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.