(28 days)
Pro Vecta 3D Prime and ProVecta 3D Prime Ceph are computed tomography x-ray units intended to generate 3D, panoramic and cephalometric (ProVecta 3D Prime Ceph Model) X-ray images in dental radiography for adult and pediatric patients. They provide diagnostic details of the maxillofacial areas for a dental treatment. The devices are operated and used by physicians, dentists, and x-ray technicians. 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 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 ProVecta 3D Prime model does not have the CEPH function.
This premarket notification is because of the biological evaluation of medical devices documentation according to EN ISO 10993-1:2020. The revision of the document is the inclusion of the Comfort Bite Foam for the bite block with direct patient contact. The relevant documents regarding biological safety were included and evaluated in this biological evaluation. Furthermore, the Biological Evaluation has been updated to the latest Version of the standard. The name, application and biocompatibility-relevant materials of the product have not changed since the last version. In addition to the current bite block (REF: 2210200100), two new, more comfortable variants were developed:
- standard bite block: an optimized version of the existing bite block
- comfort bite block: an extension of the existing bite block
The image management software was recently updated in K213326.
This document describes a 510(k) premarket notification for the "ProVecta 3D Prime and ProVecta 3D Prime Ceph" devices. The submission primarily addresses a change in the bite-block material and an updated biological evaluation, not a new or significantly altered imaging algorithm. Therefore, the information requested for acceptance criteria and a study proving device performance (especially related to AI or standalone algorithm performance) is not fully present in the provided text.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document focuses on demonstrating substantial equivalence to a predicate device (ProVecta 3D Prime Ceph, K193139) because of a change in bite-block material and an updated biological evaluation. There are no explicit "acceptance criteria" for imaging performance described in the text, nor are there reported device performance metrics in terms of clinical accuracy or diagnostic efficacy for the imaging capability itself.
The only "performance testing" mentioned relates to the new bite foam:
| Acceptance Criteria (for New Bite Foam) | Reported Device Performance (for New Bite Foam) |
|---|---|
| Not cytotoxic (based on ISO 10993 standards) | Result: Not cytotoxic. |
2. Sample size used for the test set and the data provenance
For the new bite foam testing, specific sample sizes for cytotoxicity testing are not provided in the text. There's no information on a "test set" for imaging performance, as the submission does not involve an evaluation of a new imaging algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation requiring expert-established ground truth.
4. Adjudication method for the test set
Not applicable. The submission is not about clinical diagnostic performance or AI algorithm evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. This submission is for an X-ray unit, not an AI-assisted diagnostic device. The imaging software (VisionX 3.0) is referenced as an updated component, but the submission itself is not about the performance of the software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This submission is for an X-ray unit, not a standalone algorithm.
7. The type of ground truth used
For the biological evaluation, the ground truth was established by laboratory testing for cytotoxicity based on EN ISO 10993-1, -5, -12 standards. No clinical ground truth (pathology, outcomes data, or expert consensus) for diagnostic accuracy is mentioned as this is not the focus of this 510(k).
8. The sample size for the training set
Not applicable. There is no mention of a training set as this submission is not about an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.