Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
None listed
Sponsors
Lunit INC
Eligibility
Inclusion criteria
Inclusion criteria: 1)Chest radiograph of Aged 18 years or older 2)Conventional PA or AP chest radiograph 3)Chest radiograph with confirmed radiology report that includes one or more types among the ten-target abnormal radiological findings above or interpreted as a normal.
Exclusion criteria
Exclusion criteria: 1)Chest radiograph taken in postures other than PA and AP (e.g., decubitus, oblique, lordotic, or lateral view) 2)Subtraction images acquired with dual-energy radiography 3)Invert-grayscale chest radiographs 4)Image quality not suitable for interpretation due to incorrect patient positioning, inadequate image collimation, presence of external materials such as jewelry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This clinical study is a standalone test that evaluates the single reading performance of the investigational medical device on chest radiographs. Area under the receiver operating characteristic (ROC) Curve (AUROC) of the investigational device for the detection of any abnormal findings among ten types of abnormal findings on chest radiographsTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of each abnormal radiologic finding. 1. The area under the Receiver Operating Characteristic curve (AUROC) of the investigational device for each abnormal radiologic finding. (95% confidence interval) 2. Sensitivity and Specificity of the investigational device for each abnormal radiologic findingTimepoint: 1 YEAR | — |
Countries
India
Contacts
Public ContactVasantha kumar Venugopal
Mahajan Imaging, Caring Research
Outcome results
None listed