None listed
Conditions
Interventions
Medical Device : 9 image readers* will read all the images allocated to Group A or Group B as follows, and record the reading results in the source document. When the image reading is completed, the s
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following selection criteria must be satisfied to participate in this clinical trial. 1. Brain CT images of men and women over 19 years of age. 2. Brain CT image taken for examination of suspected intracranial hemorrhage (ICH). 3. Images that can secure clinical information* of the image provider. *Clinical information: Image acquisition year, number of slices, gender, date of birth, patient type (emergency, inpatient, outpatient) ? Except for personally identifiable information. 4. Images with a score of 3 or higher in the image quality survey (refer to the image quality survey criteria table) Image quality survey criteria table 5-point scale Criteria 1 Non diagnostic due to excessive noise or artifacts 2 Diagnosis questionable due to excessive noise or artifacts, moderate decrease in confidence 3 Diagnostic with moderate but acceptable noise or artifacts 4 Mild noise, no change in confidence 5 Routine diagnostic image quality Ref) Fletcher et al. AJNR Am. J. Neruoradiol (2019), Fletcher et al. Radiology (2015) 5. 0.5 mm = z-axial slice thickness (mm) = 5 mm
Exclusion criteria
Exclusion criteria: If any of the following exclusion criteria are met, images cannot be used for this clinical trial. 1. Brain CT imaging using a contrast medium 2. Brain CT image that has already been used as a training set or validation set for the development of medical devices for clinical trials. ? In order to collect the images for this clinical trial as independent data apart from the training set or validation set, Seoul National University Hospital will use brain CT images excluding images taken from January 2009 to December 2015 as of the date of image recording, and Ajou University hospitals will use images taken on all dates, but for images from April 2004 to April 2020 as of the date of image recording, only the data, whose independence is confirmed by checking the image list provided to the institution for image identification, will be used as images for this clinical trial. 3. In case the principal investigator determines that participation in the clinical trial is inappropriate because it affects the efficacy assessment result or for other reasons (the specific reason is recorded in the case record).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Sensitivity for diagnosis of image provider (%) ,Clinical Specificity for diagnosis of image provider (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Sensitivity for CT image slice reading (%),Clinical Specificity for CT image slice reading (%) ,Accuracy for image provider diagnosis and CT image slice reading (%),Concordance rate of intracranial hemorrhage type (%),Concordance rate of intra-group image reading results;[Assessment of clinical performance of test device] ? AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve) for the algorithm of the test device. ? Sensitivity for algorithm of test device (Clinical Sensitivity, %) ? Specificity for algorithm of the test device (Clinical Specificity, %) | — |
Countries
Korea, Republic of
Contacts
Public ContactOkkyung Kang
SK
Outcome results
None listed