(85 days)
PaX-Reve3D Plus is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial 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 details 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.
PaX-Reve3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography for implantation. Specifically designed for dental radiography of the oral and craniofacial anatomy, PaX-Reve3D Plus is equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography. The computed tomography is a system based on CMOS digital X-ray detector. CMOS CT detector is used to capture scanned images in 3D for obtaining diagnostic information for craniofacial surgery or other treatments. The device can also be operated as the panoramic and cephalometire dental x-ray system based on CMOS X-ray detector.
Here's a breakdown of the acceptance criteria and the study information for the PaX-Reve3D Plus, based on the provided text:
Important Note: The provided text is a 510(k) summary for a dental computed tomography X-ray system. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and performance metrics against a clinical ground truth as might be found for novel AI devices or efficacy claims. The "performance" discussed here primarily refers to technical specifications and comparison to the predicate, not clinical accuracy or diagnostic improvement.
Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a performance study targeting specific clinical endpoints (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence by comparing technical specifications and intended use of the proposed device (PaX-Reve3D Plus) with a legally marketed predicate device (PaX-Reve3D). The implied "acceptance criteria" is that the new device's performance characteristics are either equivalent or improved compared to the predicate, and that it meets relevant safety and performance standards.
Here's a table summarizing the comparison:
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (PaX-Reve3D Plus) |
|---|---|---|
| Intended Use | PaX-Reve3D is a Computed Tomography X-Ray System for real-time image acquisition, advanced digital imaging for efficient diagnosis and information management, real-time sharing of image information on a network, and equipped with a Flat Panel Detector and CT sensor to capture 3D X-ray CT scanned images. | PaX-Reve3D Plus is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial 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 details of the anatomic structures by acquiring 360° rotational image sequences of oral and craniofacial area for precise treatment planning in adult and pediatric care. Operated by physicians, dentists, and x-ray technicians. (Identical to predicate's core functionality, with slightly more detailed description of the diagnostic utility). |
| Performance Spec. | Panoramic, cephalometric and computed tomography (Functionality) | Panoramic, cephalometric and computed tomography |
| Input Voltage | 110V/220V~ | 110V/230V~ (Slight variation, likely deemed acceptable) |
| Tube Voltage | 40-90kV | 50-100 kV (Improved range) |
| Tube Current | 2-10mA | 2~10 mA (Equivalent) |
| Focal Spot Size | 0.5mm | 0.5 mm (Equivalent) |
| Exposure Time | 0.5s-24s (Various) | 0.5-24 s (Various) (Equivalent) |
| Size of Imaging Volume | 14 x 12 cm, 10 x 6 cm, 8 x 6 cm, 5 x 5 cm | 15 x 15 cm, 12 x 8 cm, 8 x 6 cm, 5 x 5 cm (Larger options available) |
| Slice Width | 0.1mm min. | 0.1mm min. (Equivalent) |
| Total Filtration | 2.8mmAl | 2.8mmAl (Equivalent) |
| Pixel Resolution | CT: 2.5 lp/mm, Panorama: 4.5 lp/mm, Cephalometric: 3.94 lp/mm | CT: 2.5 lp/mm (Equivalent), Panorama: 5 lp/mm (Improved), Cephalometric: 3.94 lp/mm (Equivalent) |
| Pixel Size | CT: 200 µm, Panorama: 96 µm, Cephalometric: 127 µm | CT: 200 µm (Equivalent), Panorama: 100 µm (Slightly larger, possibly due to different sensor technology or field of view, but deemed acceptable given no stated inferiority in resolution), Cephalometric: 127 µm (Equivalent) |
| Image Receptor | CT with Flat Panel Detector | CT with Flat Panel Detector (Equivalent, though the proposed device uses a CMOS detector which is described in the "Description" but the table states "Flat Panel Detector" which might broadly cover it or be a slight inconsistency). |
| Software | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible (Equivalent) |
| Safety & EMC | Compliance with IEC 60601-1 (A1+A2, 1995), IEC 60601-1-3(Ed.I, 2006), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed.1, 1993), IEC 60601-2-32 (Ed.3, 2007), and IEC 60601-2044 (Ed.2+A1, 2002) and IEC 60601-1-2. Compliance with FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices." | "All test results were satisfactory." (Meets standards) |
Study Details (Relevant to 510(k) Substantial Equivalence)
The provided document describes a technical comparison and safety testing rather than a formal clinical performance study as might be conducted for an AI-powered diagnostic device.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for diagnostic evaluation. The "test set" for this submission would be the physical device itself and its components, undergoing engineering and safety testing.
- Data Provenance: Not specified for clinical data, as this is not a study assessing diagnostic accuracy on a patient cohort. The non-clinical and performance data refer to engineering and safety bench testing, likely conducted by the manufacturer (Vatech Co., Ltd.) in Korea Republic (manufacturer's location).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This type of submission relies on technical specifications and adherence to international safety and performance standards for medical devices, rather than expert-derived ground truth from interpreting medical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical ground truth established for a test set of images requiring adjudication.
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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. This device is a new imaging system hardware, not an AI software intended to assist human readers. Thus, no MRMC study or AI assistance effect size was reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical imaging hardware device, not a standalone algorithm. Its "performance" is inherent in its image acquisition capabilities, image quality specifications, and adherence to safety standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" here is compliance with established engineering standards (e.g., IEC 60601 series) and the technical specifications of the predicate device.
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The sample size for the training set:
- Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning algorithm.
In summary, the provided document demonstrates substantial equivalence by:
- Comparing the intended use, technical specifications, and performance characteristics of the PaX-Reve3D Plus to a predicate device (PaX-Reve3D).
- Showing that the proposed device is either equivalent or features minor improvements (e.g., larger imaging volume options, wider tube voltage range, slightly higher panoramic resolution) that do not raise new questions of safety or effectiveness.
- Confirming compliance with a comprehensive set of international electrical, mechanical, environmental safety, and performance standards (IEC 60601 series) and relevant FDA guidance.
The "study" that proves the device meets the (implied) acceptance criteria is the documentation of these technical comparisons and the results of the aforementioned safety and performance tests.
§ 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.