(192 days)
PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral 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 maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.
PaX-Flex3D 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 teeth or jaws, PaX-Flex3D 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 of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.
The provided 510(k) summary for PaX-Flex3D does not contain specific acceptance criteria or a dedicated study proving performance against such criteria. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (PaX-Reve3D) based on shared intended use and similar technical characteristics.
Here's a breakdown of the information available and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria (e.g., minimum resolution, specific accuracy metrics) or a table comparing device performance against such criteria is provided in the document. The "Performance Specification" section compares the technical specifications of the proposed device to the predicate device.
| Characteristic | Proposed PaX-Flex3D Performance | Predicate PaX-Reve3D Performance |
|---|---|---|
| Pixel Resolution (CT) | 3.3 lp/mm | 2.5 lp/mm |
| Pixel Resolution (Panorama) | 5 lp/mm | 4.5 lp/mm |
| Pixel Resolution (Ceph.) | 5 lp/mm | 3.94 lp/mm |
| Pixel Size (CT) | 150x150 μm / 200x200 μm | 200 μm |
| Pixel Size (Panorama) | 100x100 μm | 96 μm |
| Pixel Size (Cephalometric) | 100x100 μm | 127 μm |
| Size of Imaging Volume | 8 x 5 cm, 5 x 5 cm | 14 x 12 cm, 10 x 6 cm, 5 x 5 cm |
| Slice Width | 0.1mm min. | 0.1mm min. |
| Tube Voltage | 50-90 kV | 40-90kV |
| Tube Current | 4~10 mA | 2-10mA |
| Focal Spot Size | 0.5 mm | 0.5mm |
| Exposure Time | 9 - 24 s | 0.5s-30s (Various) |
| Total Filtration | 2.8mmAl | 2.8mmAl |
2. Sample size used for the test set and the data provenance
The document states that "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices' was performed." However, it does not provide details on:
- The specific sample size (number of images, cases, or patients) used for any such testing.
- The data provenance (country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided in the document.
4. Adjudication method 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, and its effect size
An MRMC study is not mentioned in the document. The submission focuses on device characteristics and regulatory compliance, not comparative effectiveness with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an X-ray imaging system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study (in the context of AI) would not be applicable or expected for this type of submission. The device's performance is inherently tied to image acquisition and reconstruction.
7. The type of ground truth used
As specific performance studies are not detailed, the type of ground truth used is not specified. The primary "ground truth" implied in this 510(k) is the established performance of the predicate device.
8. The sample size for the training set
This device is an imaging system, not an AI model requiring a "training set" in the machine learning sense. Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no "training set" for an AI model, this information is not applicable and not provided.
Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):
The submission primarily relies on design and performance specifications comparison to a legally marketed predicate device (PaX-Reve3D) and adherence to recognized electrical, mechanical, environmental safety, and performance standards, as well as FDA guidance for solid-state X-ray imaging devices.
The key "study" mentioned is the execution of "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices'." However, the details of these considerations, including specific test methodologies, results, or data sets, are not enumerated in this summary. The conclusion states that "All test results were satisfactory," implying that the device met internal or regulatory benchmarks relevant to its classification and intended use, aligning with the predicate device's performance and safety profiles. The mechanism for "proving" acceptance is largely through demonstrating substantial equivalence to an already cleared device and compliance with relevant safety standards.
§ 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.