(203 days)
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
The provided document is a 510(k) premarket notification letter from the FDA to Elucid Bioimaging, Inc. concerning their device, vascuCAP. While it outlines the device's intended use and the general process of software verification and validation, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment methods, or whether MRMC studies were conducted.
The document indicates that software verification and validation were performed consistent with FDA guidance on "General Principles of Software Validation," and that "Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions." However, it does not present the results of this validation in a quantitative manner or specify the details requested in your prompt.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study design and results from the provided text. The document concludes that "vascuCAP is as safe and effective as the predicate device for the intended use" based on this general testing, but the specifics of how that was demonstrated are not included.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).