Cleerly LABS (v2.0)

Cleerly LABS (v2.0) is a web-based software application designed to assist trained medical professionals in analyzing cardiac CT data for the presence and extent of coronary plaques and stenosis in patients undergoing CCTA. It utilizes machine learning to automate image segmentation and vessel delineation, allowing for visualization and measurement of coronary arteries, with user refinement capabilities, to enhance the efficiency of coronary artery disease assessment.

Cleerly LABS (v2.0) is a web-based software application intended for use by trained medical professionals. It functions as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data, specifically to determine the presence and extent of coronary plaques and stenosis. This analysis is performed for patients who have undergone Coronary Computed Tomography Angiography (CCTA) for the evaluation of, or suspected, coronary artery disease. The software post-processes CT images obtained from any CT scanner and provides tools for the measurement and visualization of coronary arteries. It is important to note that the software is not intended to replace the skill and judgment of a qualified medical practitioner, and its effective use requires appropriate training. This version of the medical imaging software has been determined to be substantially equivalent to a previously marketed device, Cleerly LABS v2.0. Classified as a Class II Medical Image Management and Processing System, the updated software features modifications to product labeling, changes to its operating workflow, and minor technological enhancements. It employs machine learning to identify high-quality images, segment, and label coronary arteries, and delineate lumen and vessel walls. Users can then refine these segmentations, adjust thresholds, and mark stenoses, stents, or chronic total occlusions, with the software producing a comprehensive CORONARY Report. These improvements aim to enhance the efficiency of time-consuming manual tasks for medical professionals in assessing coronary artery disease, without altering the core machine learning algorithms or mathematical calculations. Software testing has confirmed that the device remains safe, effective, and performs as intended.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the machine learning algorithm specifically identify high-quality images and what are its performance metrics (e.g., sensitivity, specificity) in this task?; What is the inter-reader and intra-reader variability when using Cleerly LABS (v2.0) for plaque and stenosis assessment, even with user refinement capabilities?; Are there any validated clinical outcomes studies demonstrating that the use of Cleerly LABS (v2.0) improves patient management or reduces major adverse cardiovascular events compared to traditional CCTA interpretation?; What are the specific "minor technological enhancements" and "changes to its operating workflow" in v2.0, and how do they impact diagnostic accuracy or workflow efficiency?; How does the software handle imaging artifacts or unusual anatomical variations that might challenge its automated segmentation and delineation capabilities?