Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lunit Inc.
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- the effectiveness of the investigational device
研究概览
简要总结
This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chest radiographs of aged 14 years or older
- •Conventional PA or AP chest radiographs
- •Chest radiographs with confirmed radiology reports
排除标准
- •Chest radiographs taken in postures other than PA and AP
- •Chest radiographs from dual-energy radiography
- •Invert-grayscale chest radiographs
结局指标
主要结局
the effectiveness of the investigational device
时间窗: through study completion, an average of 6 months
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)
次要结局
未报告次要终点