Company: JLK Inc. Product: JBS-04K
Deep learning-assisted detection of intracranial hemorrhage: validation and impact on reader performance
Neuroradiology, 2025
Abstract
Purpose
Intracranial hemorrhage (ICH) requires urgent treatment, and accurate and timely diagnosis is essential for improving outcomes. This pivotal clinical trial aimed to validate a deep learning algorithm for ICH detection and assess its clinical utility through a reader performance test.
Methods
Retrospective CT scans from patients with and without ICH were collected from a tertiary hospital. Two experts evaluated all scans, with a third expert reviewing disagreements for the final diagnosis. We analyzed the performance of the deep learning algorithm, JLK-ICH, for all cases and ICH subtypes. Additional external validation was performed using a multi-ethnic U.S.
Dataset
A reader performance study included six non-expert readers who evaluated 800 CT scans, with and without JLK-ICH assistance, following a washout period. ICH presence and five-point scale confidence level for decisions were rated.
Results
A total of 1,370 CT scans were evaluated. The deep learning model showed 98.7% sensitivity (95% confidence interval [CI] 97.8-99.3%), 88.5% specificity (95% CI, 83.6-92.3%), and an area under the receiver operating characteristic curve (AUROC) of 0.936 (95% CI, 0.915-0.957). The model maintained high accuracy across all ICH subtypes, and additional external validation confirmed these results. In the reader performance study, AUROC with JLK-ICH assistance (0.967 [0.953-0.981]) surpassed that without assistance (0.953 [0.938-0.957]; P = 0.009). JLK-ICH particularly improved performance when readers were highly uncertain.
Conclusion
The JLK-ICH algorithm demonstrated high accuracy in detecting all ICH subtypes. Non-expert readers significantly improved diagnostic accuracy for brain CT scans with deep learning assistance.
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