(3 days)
The AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher.
AutoBone is an optional software extension of the Volume Viewer application for Advantage Workstation. This software can be used in order to facilitate visualization of vessel features and assist in segmentation of bony structures.
The provided document is a 510(k) summary for the GE AutoBone device. It details the device's intended use and substantial equivalence to predicate devices but does not include any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an acceptance criteria table or a detailed study description.
The document explicitly states: "The AutoBone does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AutoBone to be equivalent to those of Volume Rendering (K972399) and Vitrea 2 (K002519)." This suggests a reliance on substantial equivalence rather than new performance studies with specific acceptance criteria.
Therefore, based on the provided text, I cannot fill in the requested information. The document does not contain the details necessary to create a table of acceptance criteria and reported device performance or to describe a specific study proving the device meets acceptance criteria.
§ 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.