(176 days)
PreXion3D Expedition is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, ENT (Ear, Nose and Throat) and neck region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
PreXion3D Expedition consists of a scanner, which is used for generating X-ray and detecting image data, and a console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Explore Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating crosssection diagram, etc.), and output the image to a printer.
X-ray image data is acquired while the rotation arm is rotating around the secured "patient's head" at a constant speed. X-rays, which are emitted from X-ray generator (built in one side of rotation arm), pass through a patient and are detected by the flat panel detector (built in the other side of rotation arm). The detected X-ray absorption data is used to process image reconstruction on the Console to create the 3D image (CT scan), the tomographic image (CT scan, Panoramic scan) and Cephalometric Scan.
The FDA 510(k) summary for the PreXion3D Expedition describes the device and its claimed substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets them. This document is a regulatory filing, primarily focused on demonstrating substantial equivalence based on technical characteristics and intended use, rather than providing a detailed performance study with specific acceptance criteria and outcome metrics for AI/ML components.
Specifically, the document states: "No clinical testing was performed and that the non-clinical testing provided in this submission supports the substantial equivalence of the device." This confirms that there was no performance study of the kind typically used to evaluate AI model performance (e.g., assessing diagnostic accuracy against ground truth).
Therefore, I cannot extract the requested information from the provided text. The tables and sections related to "Technological Characteristics and Performance" are comparing device specifications (e.g., X-ray generation, detector types, physical dimensions) to predicate devices, not reporting on the performance of an AI component against specific diagnostic acceptance criteria.
To answer your questions, one would typically need access to a detailed clinical validation study report for an AI-powered diagnostic device, which is not present in this 510(k) summary.
§ 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.