GE HealthCare gets 510(k) clearance for algorithm to detect collapsed lungs

Dive Brief:

GE HealthCare received 510(k) clearance for an on-device algorithm for the detection and notification of collapsed lungs in chest X-ray images.
The system, called Critical Care Suite 2.1, provides immediate notification of the presence of a collapsed lung, known medically as a pneumothorax, to support the triaging of emergency room patients.
Adding on-device pneumothorax detection and triage notifications expands the capabilities of the product, the first version of which was cleared by the Food and Drug Administration in 2019.

Dive Insight:

In a 510(k) clearance letter sent in May, GE HealthCare said it developed the pneumothorax detection algorithm using more than 12,000 images from six sources, including the National Institutes of Health. GE HealthCare split the images into training, verification and validation datasets, excluding 804 images from two North American sites from the training process to support the final validation.

The algorithm achieved a sensitivity of 84.3% and a specificity of 93.2% for the detection of pneumothoraces on both anteroposterior and posteroanterior frontal chest X-ray images, according to data in the letter. Sensitivity was higher for large pneumothoraces (96.3%) than for small pneumothoraces (75%).

When 10 independent readers analyzed 400 images from the validation dataset, the algorithm improved performance for the detection of pneumothorax, measured by mean area under the curve, by 14.5%, according to the letter. Reader sensitivity increased by 16.3% and reader specificity increased by 12.4%.

GE HealthCare sees the data as evidence that the algorithm can help manage order volumes and cut turnaround times for reports.

“The adoption of these digital solutions helps unlock efficiencies across the entire clinical workflow and empowers radiologists and their teams in making critical decisions with confidence in time-sensitive situations,” Jyoti Gupta, president and CEO of women’s health and X-ray for GE HealthCare, said in a statement.

GE HealthCare’s clearance follows an FDA decision on Aidoc technology for the triage and notification of pneumothorax on X-ray exams. Aidoc’s algorithm runs on all X-ray machines and received 510(k) clearance in March 2022.