(52 days)
The Cardiac CT Function Software Application is indicated to be used with multi-phase, multi-slice cardiovascular CT angiography images to assist qualified medical professionals in assessing and evaluating cardiac function. CT Function includes manual and semi-automatic heart segmentation of 2 chambers (LV and RV) and calculation of cardiac function metrics including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass.
Circle's Cardiac CT Function Software Application ("CT Function Module" or "CT Function", for short) is a software device that enables the analysis of cardiac images acquired using computed tomography (CT) scanners. It is designed to support physicians in the visualization, and analysis of heart function through the calculation of parameters such as volume and mass. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The CT Function Module does not interface directly with any data collection equipment, and its functionality is dependent on the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review.
CT Function consists of multiplanar reconstruction (MPR) views and 3D rendering of the original CT data. The module displays three MPR views that the user can freely adjust to any position and orientation. Lines and regions of interest (ROIs) can be manually drawn on these MPR images for quantitative measurements.
The CT Function Module implements an Artificial Intelligence / Machine Learning (AI/ML) algorithm to detect and segment heart structures and post-processing methods to convert the heart segments to editable surfaces. All surfaces generated by the system are editable and users are advised to verify and correct any errors; if desired, users can also perform seqmentation of the cardiac structures manually using surface contour generation tools.
Here's a breakdown of the acceptance criteria and study details for the Cardiac CT Function Software Application, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Region | Acceptance Criteria (Implied from "less than X%" or "above Y%") | Reported Device Performance |
|---|---|---|---|
| Mean Absolute Error (MAE) for Volume Prediction | LV Cavity | 86% | > 86% |
| 3D Hausdorff Distance (HD) | LV Cavity | 85% | > 85% |
| 3D Hausdorff Distance (HD) | RV Cavity | 82% | > 82% |
| 3D Hausdorff Distance (HD) | LV Myocardium |
§ 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).