(56 days)
The PaX-500 is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
PaX-500 is an extraoral dental digital x-ray source generating diagnostic X-ray imaging from Digital Tomography, Panoramic, and Cephalometric dental X-ray modality. This Xray system device is based on digital X-ray imaging sensor to capture X-ray digital tomogram scanned Image for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
The provided document is a 510(k) summary for the PaX-500, a digital dental panoramic and cephalostat with computed tomography x-ray system. It details the device's technical specifications, indications for use, and a comparison to a predicate device. However, this document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, sample sizes, expert evaluations, or MRMC studies.
The document states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2, EN/IEC 61000-3-2 and EN/IEC 61000-3-3. All test results were satisfactory." This indicates that the device met the requirements of these general safety and performance standards for medical electrical equipment, but it does not specify performance criteria for diagnostic accuracy, image quality, or clinical effectiveness in a way that can be quantified in a table of acceptance criteria vs. device performance, or describe a study that validates such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance for substantial equivalence to a predicate device based on general safety and performance standards, not on a detailed clinical performance study with defined acceptance criteria for diagnostic capability.
§ 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.