Auto Lung Nodule Detection
Samsung Electronics Co.,Ltd.Auto Lung Nodule Detection is a computer-aided detection software designed by Samsung Electronics to assist physicians in identifying and marking suspected pulmonary nodules between 10 and 30 mm on PA chest X-rays. Integrated into Samsung's digital X-ray systems, it serves as a second reader by highlighting regions of interest on images to support radiologists in their interpretation and improve detection accuracy.
Intended Use
The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.
Technology
Auto Lung Nodule Detection operates as a computer-aided detection (CAD) software integrated with Samsung Digital X-ray Imaging Systems. It receives PA chest X-ray DICOM images, applies machine learning techniques to identify suspected nodules sized 10-30 mm, and outputs marked images with circular ROI indicators on the visualization software S-Station. It functions as a second reader without altering original images.
Performance
Non-clinical testing confirmed software compliance with FDA Quality System Regulations and international standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366-1). Clinical evaluation demonstrated statistically significant improvement in nodule detection performance by radiologists when using the device, measured through sensitivity, false positives per image, and JAFROC figure of merit.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/10/2020
1 year, 2 months - 2
FDA Approval
8/31/2021
Other devices from Samsung Electronics Co.,Ltd.
- GM852024 • 510K
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