GE HealthCare has received 510(k) clearance for its on-device algorithm designed to detect and notify healthcare professionals about pneumothorax in chest X-ray images. The system, named Critical Care Suite 2.1, offers immediate notifications when it detects the presence of a collapsed lung, medically known as pneumothorax, enhancing the triaging process for emergency room patients. This expanded capability builds upon the initial version of the product, which received clearance from the Food and Drug Administration (FDA) in 2019.
GE HealthCare’s Critical Care Suite 2.1 introduces on-device pneumothorax detection and triage notifications, aiming to improve the efficiency and speed of the triaging process in emergency rooms. This advancement in technology provides rapid notifications to healthcare providers when a collapsed lung is detected in chest X-ray images, allowing them to prioritize patient care more effectively.
Pneumothorax Detection Algorithm’s Impressive Sensitivity and Specificity Rates
In May, GE HealthCare submitted a 510(k) clearance letter detailing the development of its pneumothorax detection algorithm. This algorithm was trained using over 12,000 chest X-ray images from six different sources, including the National Institutes of Health. The images were divided into training, verification, and validation datasets. Notably, 804 images from two North American sites were excluded from the training process to facilitate final validation.
The algorithm exhibited impressive results, with a sensitivity of 84.3% and a specificity of 93.2% for detecting pneumothoraces in both anteroposterior and posteroanterior frontal chest X-ray images. Additionally, it achieved higher sensitivity for large pneumothoraces (96.3%) compared to small ones (75%).
When 10 independent readers analyzed 400 images from the validation dataset, the algorithm showed substantial improvement in pneumothorax detection, measured by the mean area under the curve. Reader sensitivity increased by 16.3%, while reader specificity increased by 12.4%.
Algorithm Revolutionizes Clinical Workflow and Boosts Radiologist Confidence
GE HealthCare views this data as strong evidence that the algorithm can help manage order volumes and reduce turnaround times for medical reports. Jyoti Gupta, President and CEO of Women’s Health and X-ray for GE HealthCare, emphasized that the adoption of digital solutions like this algorithm enhances the overall clinical workflow and empowers radiologists and their teams to make critical decisions with confidence, particularly in time-sensitive situations.
GE HealthCare’s 510(k) clearance follows a similar FDA decision regarding Aidoc technology for triaging and notifying healthcare professionals about pneumothorax in X-ray exams. Aidoc’s algorithm, compatible with all X-ray machines, received its own 510(k) clearance in March 2022.
Resource: Medtechdive, November 29, 2023
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