CT Cardiomegaly
Innolitics, LLCCT Cardiomegaly is a command-line software tool designed to automatically measure the cardiothoracic ratio from CT chest images. It uses machine learning algorithms to segment the heart and thoracic cavity and calculate both linear and area-based cardiothoracic ratios. This assists physicians in identifying cardiomegaly, providing quantitative measurements to support clinical decisions within healthcare settings.
Intended Use
CT Cardiomegaly is a command line software application intended to be run on its own or as part of another medical device to automatically calculate linear and area based cardiothoracic ratio (CTR) from a CT image containing the heart. It measures the maximal transverse diameter of the heart and maximal inner transverse diameter of thoracic cavity using a non-adaptive machine learning algorithm. The intended users are physicians or licensed practitioners in healthcare institutions.
Technology
CT Cardiomegaly is a software-only (SaMD) device that applies automated non-adaptive machine learning algorithms using the MONAI framework to segment the heart and thoracic cavity on axial CT slices and calculate cardiothoracic ratios. It outputs PDF and JSON reports containing linear and area-based CTR measurements. It operates as a command line tool and has been developed and validated using a large database of CT images from multiple sites.
Performance
Performance testing showed strong agreement with manual measurements by board-certified radiologists, with a mean difference less than 0.01 for both linear and area-based cardiothoracic ratios, meeting targeted clinical endpoints. Clinical accuracy and precision, including heart slice detection and segmentation quality, were validated on an independent testing dataset of 275 cases from diverse sites and manufacturers. Verification and validation testing confirmed the software met design requirements and user needs.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/28/2023
6 months - 2
FDA Approval
2/28/2024
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