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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.
In addition, to investigate the effect of Lunit INSIGHT CXR assistance on the interpreting physician's interpreting performance, a multi-reader, multi-case (MRMC) study was conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive | chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax) |
| |
| Negative | chest radiographs with no target radiologic findings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-ray | Radiation | Chest radiographs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings | To evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities, 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) will be measured | Through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The secondary hospital patients
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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 |