(162 days)
VOLUX 21C is a Computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians.
VOLUX 21C is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometry and computed tomography. VOLUX 21C designed for dental radiography of the oral and craniofacial anatomy. VOLUX 21C is equipped with extra-oral x-ray detector based on CMOS digital X-ray detector, CT & panoramic radiography with an extra-oral x-ray tube. CMOS digital X-ray detector is used to capture scanned image in 3D for obtaining diagnostic information for craniofacial surgery or other treatments. And VOLUX 21C can also be operated as the cephalometric dental x-ray system based on CCD X-ray detector.
The provided text describes the regulatory clearance of a medical device, VOLUX 21C, by the FDA. It does not contain detailed information about specific acceptance criteria being met through a dedicated study with quantified performance metrics, sample sizes, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards.
However, I can extract the information that is present and indicate what is not explicitly detailed.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance reports in the way one would expect for a study. It instead focuses on substantial equivalence to the predicate device, PaX-Reve3D Plus, by comparing technical specifications and intended use. The "Performance Specification" is listed as "Panoramic, Cephalometric and Computed tomography" for both the new device and the predicate, implying functional equivalence rather than quantitative performance thresholds.
| Feature | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VOLUX 21C) |
|---|---|---|
| Indications for Use | "Produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians." (Identical to predicate) | "Produce panoramic, cephalometric or cross-sectional images of the oral and cranioifacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care. The device is operated and used by physicians, dentists and x-ray technicians." |
| Imaging Modalities | Panoramic, Cephalometric and Computed tomography (Identical to predicate) | Panoramic, Cephalometric and Computed tomography |
| Input Voltage | 120V~ | |
| Tube Voltage | 50-100kV (Predicate) | 60~110 kV |
| Tube Current | 2-10mA (Predicate) | 5~7mA (CT, Panorama), 20mA (Cephalo) |
| Focal Spot Size | 0.5mm (Predicate) | 0.5mm, 1.5mm |
| Exposure Time | 0.5-24s (Predicate) | 0.5-17s (Various) |
| CT FOV | 150x150mm, 120x80mm, 80x60mm, 50x50 mm (Predicate) | 145mm x 85mm |
| Slice Width | 0.1mm min (Predicate) | 0.14mm min |
| Total Filtration | 2.8mmAl (Predicate) | 2.5mmAl |
| Pixel Size (CT) | 200 µm (Predicate) | 150 µm |
| Image Receptor | CT with Flat Panel Detector (Predicate) | CT with Flat Panel Detector, Cephalo with CCD Detector |
| Safety and Performance | Satisfactory results from tests against IEC 60601 series, IEC 61223 series, and FDA Guidance for Solid State X-ray Imaging Devices. (Implied) | "All test results were satisfactory." and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (General statement of compliance) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices," but it does not provide details on the sample size used for the clinical evaluation, data provenance (country of origin), or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The text refers to "clinical evaluation" but does not detail how ground truth was established or the qualifications of any experts involved in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document describes a conventional medical imaging device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable in this context. The evaluation is focused on the device's inherent imaging capabilities and safety compared to a predicate X-ray system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance. As mentioned above, this device is a traditional X-ray system, not an AI-driven one. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not explicitly provided in the document. The statement "clinical evaluation" is too general to infer the type of ground truth used.
8. The sample size for the training set
This refers to AI model training. Since the device is a conventional X-ray system and not an AI algorithm, there is no mention of a training set.
9. How the ground truth for the training set was established
As there is no training set mentioned for an AI model, this information is not applicable.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.