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This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities
In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive group | chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax) |
| |
| Negative group | chest radiographs with no target radiologic findings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest X-ray | Radiation | Chest radiographs |
|
| Measure | Description | Time Frame |
|---|---|---|
| the effectiveness of the investigational device | Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings (detection of any abnormal findings among ten target radiologic findings) | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary hospital patient
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| D011827 | Radiation |
| D011839 | Radiation, Ionizing |