Deep learning system improved detection efficacy of fetal intracranial malformations in a randomized controlled trial

Congenital malformations of the central nervous system are among the most common major congenital malformations. Deep learning systems have come to the fore in prenatal diagnosis of congenital malformation, but the impact of deep learning-assisted detection of congenital intracranial malformations from fetal neurosonographic images has not been evaluated. Here we report a three-way crossover, randomized control trial (Trial Registration: ChiCTR2100048233) that assesses the efficacy of a deep learning system, the Prenatal Ultrasound Diagnosis Artificial Intelligence Conduct System (PAICS), in assisting fetal intracranial malformation detection. A total of 709 fetal neurosonographic images/videos are read interactively by 36 sonologists of different expertise levels in three reading modes: unassisted mode (without PAICS assistance), concurrent mode (using PAICS at the beginning of the assessment) and second mode (using PAICS after a fully unaided interpretation). Aided by PAICS, the average accuracy of the unassisted mode (73%) is increased by the concurrent mode (80%; P < 0.001) and the second mode (82%; P < 0.001). Correspondingly, the AUC is increased from 0.85 to 0.89 and to 0.90, respectively (P < 0.001 for all). The median read time per data is slightly increased in concurrent mode but substantially prolonged in the second mode, from 6 s to 7 s and to 11 s (P < 0.001 for all). In conclusion, PAICS in both concurrent and second modes has the potential to improve sonologists’ performance in detecting fetal intracranial malformations from neurosonographic data. PAICS is more efficient when used concurrently for all readers.