A Study to Evaluate Chang Gung Pneumothorax Detection Software

Study Overview
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Brief Summary
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The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Detailed Description
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This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format. Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.

Official Title
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A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians

Conditions
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Pneumothorax

Intervention / Treatment
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* Device: Chang Gung Pneumothorax Detection Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The case were over 20 years old and under 100 years old. DICOM format. Brand model of Canon. DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels). poster-anterior view(PA-view) of chest X-ray Exclusion Criteria: The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms. The chest X-ray that are difficult to interpret due to poor image quality.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Software diagnosis<br>Software diagnosis with gold standard of 3 doctors' interpretation. | Device: Chang Gung Pneumothorax Detection Software<br>* The Chang Gung Pneumothorax Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pneumothorax. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pneumothorax. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The rate of test results that correctly indicate the presence. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | The rate of test results that correctly indicate the absence. | baseline | 
| Area Under the receiver operating characteristic Curve | A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence