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ProVecta 3D Prime:

ProVecta 3D Prime is computed tomography x-ray unit intended to generate 3D and panoramic X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians. Not intended for mammography use.

VistaSoft:

The VistaSoft software functions for recording, displaying, analyzing, diagnosing, managing and sending digital or digitized video and X-ray images in dental practices and specialist dental clinics. Not intended for mammography use.

This device is a cone beam CT x-ray device for the acquisition of dental images. Similar to computer tomography or magnetic resonance tomography, sectional images can be generated with CBCT. With CBCT, an X-ray tube and an imaging sensor opposite it rotate around a seated or standing patient. The X-ray tube rotates through 180°-540° and emits a conical X-ray beam. The X-rays pass through the region under investigation and are measured for image generation by a detector as an attenuated grey scale X-ray image. Here, a large series of two-dimensional individual images is acquired during the revolution of the X-ray tube. Using a mathematical calculation on the rotating image series via a reconstruction computer, a grey value coordinate image is generated in the three spatial dimensions. This three-dimensional coordinate model corresponds to a volume graphic that is made up of individual voxels. This volume can be used to generate sectional images (tomograms) in all spatial dimensions as well as 3D views. The system complies with US Radiation Safety Performance Standard.

The provided text is a 510(k) Premarket Notification summary for the ProVecta 3D Prime with VistaSoft device, a dental computed tomography x-ray system. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and performance study details is not explicitly available in this document.

However, based on the information provided, here's what can be inferred and explicitly stated:

Overall Conclusion from the Document:
The device's performance is not evaluated against formal "acceptance criteria" in the sense of a new feature or algorithm being validated. Instead, the focus is on demonstrating that the device's technical characteristics and image quality are equivalent or non-inferior to the predicate device, thereby not raising new questions of safety or effectiveness. The statement "The overall impression is sufficient for dental diagnostics. Good contrast and good resolution. Teeth, osseous structures, sinus maxillaries are clearly shown" acts as a qualitative assessment of diagnostic quality, though not tied to specific acceptance criteria.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission primarily focused on demonstrating substantial equivalence, formal quantifiable "acceptance criteria" for a new AI algorithm's performance are not explicitly defined or measured in a distinct table in the provided text. The performance assessment is comparative to the predicate device's specifications for imaging parameters.

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