(190 days)
uCT ATLAS Astound is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS Astound is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS Astound is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.
uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.
uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
The proposed device CT system with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.
The proposed CT system is designed to use less radiation dose. Further, the fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.
The computer system delivered with the CT scanner is able to run post processing applications optionally.
The Computed Tomography System family scanners referenced in this submission are comparable in indications for use, and are substantially equivalent in design, material, functionality, technology, energy source and are substantially equivalent to the predicate devices. The reason for this submission is to support the following additional function:
CT intervention provides real-time CT fluoroscopy at 12 IPS with in-room view and in-room X-ray control. It allows the user to adjust the scan parameters during operation, and scan modes can be switched according to technician's operation requirements. Entry path planning based on 2D and 3D images.
The CT guided intervention will be applicable for the UIH qualified CT systems. This indication will also be applicable for future qualified UIH CT systems.
I am sorry, but the provided text does not contain sufficient information to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is primarily a 510(k) premarket notification letter from the FDA, outlining regulatory compliance and substantial equivalence to predicate devices, and includes device descriptions, indications for use, and a comparison of technological characteristics.
It mentions "Non-clinical testing including dosimetry and image performance tests were conducted...to verify that the proposed device met all design specifications," and lists relevant standards and guidance documents. It also states "The features described in this premarket submission are supported with the results of the testing mentioned above, the proposed device was found to have a safety and effectiveness profile that is similar to the predicate device." However, it does not provide:
- A table of specific acceptance criteria and reported device performance.
- Details about the study's design, such as sample size, data provenance, number or qualifications of experts, or adjudication methods for ground truth creation.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used, or the sample size and ground truth establishment methods for a training set.
Therefore, I cannot populate the requested table or provide the specific study details you've asked for based on the given input.
§ 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.