This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT). Using the investigational device, analyze the image and the onset time of occurrence of acute ischemic stroke lesion on the brain image (4.5 hours or more from the onset of symptoms) and evaluate the efficacy of correctly estimating the onset time.
This clinical trial software medical device (Model name: NNS-SOT) is developed based on artificial intelligence algorithms. Through clinical validation, it will be easier to determine whether the golden hour (4.5 hours) has elapsed at the time of cerebral infarction in the medical field. It can be used for estimation of the onset time of occurrence in acute ischemic stroke.
Study Type
OBSERVATIONAL
Enrollment
474
Asan Medical Center
Seoul, South Korea
Sensitivity and specificity
Evaluation of sensitivity and specificity of clinical performance (estimation of 4.5 hours or more after cerebral infarction) performed with clinical trial medical device
Time frame: October - November 2023
Area Under the Curve(AUC), which is the lower area of the Receiver Operating Characteristics(ROC) curve
Lower limit of 95% confidence interval is 80% or more
Time frame: October - November 2023
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