None listed
Conditions
Interventions
Medical Device : Uploading a subject’s fundus image on the software(VUNO Med-Fundus AI ) to detect any abnormal findings
*The investigational medical device is Computer aided diagnosis software.
- Ap
Sponsors
Vuno
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults at the age 19 or above who received the fundus examination within the period from July 2016 to June 2018 2) When an abnormal finding in the fundus image can be confirmed based on the physical examination result or medical records *If the subject received the fundus examination more than 2 times, only the first examination result is included. - Up to 1713 images [269 images without an abnormal finding and 1444 images with an abnormal finding (including those with 2 or more abnormal findings)] -When the clinical study is conducted, the actual number of fundus images collected will not exceed the maximum number since the fundus image database will be built per abnormal finding type. That is, a fundus image without a certain abnormal finding type can be included as a fundus image without other abnormal findings except the certain finding.
Exclusion criteria
Exclusion criteria: 1) When a fundus image is not suitable for reading because there are serious cataracts or corneal opacities in the eye from which the fundus image was taken 2) Those who are otherwise considered by the investigator to be not suitable for participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC (area under curve): Area under the ROC (receiver operating characteristic) curve, evaluated for 12 each abnormal finding | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity(evaluated for 12 each abnormal finding): The proportion that the investigational medical device detected an abnormal finding in the eye confirmed to have that abnormal finding by two or more radiologists;Specificity(evaluated for 12 each abnormal finding): The proportion that the investigational medical device did not detect an abnormal finding in the eye confirmed to not have that abnormal finding by all of three radiologists;Overall accuracy: The proportion that the investigational medical device provided the same detection result for the eye confirmed to have or not have an abnormal finding by the radiologists (regardless of the type of abnormal finding);Overall sensitivity: The proportion that the investigational medical device detected presence of an abnormal finding in the eye confirmed to have an abnormal finding by two or more radiologists (regardless of the type of abnormal finding);Overall specificity: The proportion that the investigational medical device did not detect any abnormal finding in the eye confirmed to not have any abnormal findings by all of three radiologists | — |
Countries
Korea, Republic of
Contacts
Public ContactKwangsic Joo
Seoul National University Bundang Hospital
Outcome results
None listed