(15 days)
CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.
CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.
Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus. its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CTMR.
CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography requires Navigator2 for its operation however, Navigator2 can also be utilized as a stand-alone option. Navigator2 is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both, CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.
While the document describes the device, its intended use, and its equivalence to a predicate device, it does not contain information regarding specific acceptance criteria for a study or the results of such a study proving the device meets those criteria.
The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data against defined acceptance criteria.
Therefore, I cannot provide the requested information. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are not present in the provided text.
§ 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.