(113 days)
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.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance |
|---|---|
| Safety: | Complies with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-3 (Radiation Protection in Diagnostic X-Ray Equipment), IEC 60825-1 (Safety of laser products). |
| Essential Performance: | Verified through compliance with IEC 60601-1, IEC 60601-2-63 (Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment). |
| Image Quality (Dental Radiography): | Acceptance testing was performed for both panoramic and cephalometric modes according to DIN 6868-151 (Image quality assurance in diagnostic X-ray departments - Acceptance testing of dental radiographic equipment) and DIN 6868-161 (Image Quality Assurance In Diagnostic X-Ray Departments - Acceptance Testing Of Dental Radiographic Equipment For Digital Cone-Beam Computed Tomography). Line pair and contrast were evaluated using a phantom designed for this purpose. The device's technological characteristics (kV, mA, focal spot, detector) are similar to the predicate. |
| Usability: | Complies with IEC 60601-1-6 (Usability) and IEC 62366 (Application of usability engineering to medical devices). |
| Software Life-cycle Processes: | Complies with IEC 62304 (Medical Device Software Life-cycle processes). Firmware evaluated according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; risk management documented. |
| Biocompatibility: | Chin Holder (material PBT) complies with EN ISO 10993-5 (Cytotoxicity). Other accessories were previously cleared. |
| Substantial Equivalence: | The device is deemed substantially equivalent to the predicate (K152106) and reference device (K181432) regarding technology, performance, and indications for use. Key performance differences with the reference device (K181432, which lacked CEPH) are resolved by the addition of cephalometric capability, making it entirely equivalent to 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.
§ 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.