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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:

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.

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ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric Xray images in dental radiography for adult and pediatic 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.

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 Xrays 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. This device is similar to our reference device, K181432, but we have now added cephalometric capability, making it entirely equivalent to our predicate device for indications. An option would allow the customer to purchase this new device without the CEPH function, if desired.

Here's a breakdown of the acceptance criteria and study information for the ProVecta 3D Prime Ceph based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not include specific acceptance criteria in numerical or quantifiable terms (e.g., minimum sensitivity/specificity, specific image quality scores). Instead, it relies on demonstrating compliance with recognized standards and comparing its performance to a predicate device.

The "reported device performance" primarily comes from conformity to these standards and the implicit performance derived from its technological characteristics being similar to or the same as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of patient data or clinical images. The testing described focuses on non-clinical performance and engineering standards (e.g., electrical safety, image quality with phantoms).

• Test Set Sample Size: Not applicable/not provided for patient data.
• Data Provenance: Not applicable, as no patient data test set is described. The non-clinical testing appears to have been conducted by the manufacturer, presumably in Germany (country of origin for DÜRR DENTAL SE).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided as the evaluation relies on non-clinical phantom-based testing and compliance with recognized standards, rather than expert-derived ground truth from clinical images.

4. Adjudication Method for the Test Set

This information is not provided as the evaluation relies on non-clinical phantom-based testing and compliance with recognized standards.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and thus, no effect size of human reader improvement with AI assistance is reported. This device is an X-ray imaging system, not an AI-powered diagnostic aid for interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. The device is a medical imaging hardware system.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established through:

• Phantoms: For image quality assessment (line pair, contrast).
• Engineering Standards: Electrical safety, radiation protection, EMC, usability, software life-cycle, and biocompatibility standards provide the "ground truth" for compliance.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is demonstrating that the ProVecta 3D Prime Ceph performs as safely and effectively as the legally marketed predicate device (Vatech Co. Ltd. PaX-i3D Smart, K152106).

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an X-ray imaging system, not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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