Search Results

The VOLUX consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes dental and maxillofacial areas, for use in planning and diagnostic support. VOLUX comprises a package of PC software modules to expand TRIANA capabilities to handling 3D data. This includes 3D reconstructions, storage, retrieval, viewing and processing of 3D-image data.

The VOLUX comprises of the VOLUX-device, the reconstruction server and the 2D and 3D viewing client TRIANA. The VOLUX device generates a conical x-ray beam that rotates round the patient's head within a ccrtain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The VOLUX features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.

The provided text describes a 510(k) premarket notification for the "Digital Extraoral Source X-Ray System / Model: VOLUX". This document details the device and its indications for use, but it does not contain a study that proves the device meets specific acceptance criteria.

The document states: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, it does not provide the specifics of these evaluations, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them using the provided input. The input lacks the necessary information to reconstruct such a table and study description.

Here's what can be extracted from the text, but it does not address the core of your request:

• Device: Digital Extraoral Source X-Ray System / Model: VOLUX
• Intended Use: Provides two-dimensional images and three-dimensional volume reconstructions of the head area (dental and maxillofacial) for planning and diagnostic support. This includes 3D reconstructions, storage, retrieval, viewing, and processing of 3D-image data.
• Predicate Devices:
  • CB MercuRay (K033248)
  • Galileos (K060892)
• Regulatory Class: Class II, Product Code MUH (System, X-ray, Extraoral Source, Digital)
• 510(k) Number: K092171
• Submission Date: March 23, 2010
• Decision Date: April 26, 2010
• Manufacturer: GENORAY Co., Ltd.

To answer your request, a detailed performance study report with predefined acceptance criteria would be needed, which is not present in this 510(k) summary.

Ask a specific question about this device