Lunit INSIGHT DBT v1.1
Lunit Inc.Lunit INSIGHT DBT v1.1 is an AI-powered software designed to assist physicians in detecting and characterizing suspicious breast lesions in digital breast tomosynthesis exams. It marks regions of potential cancer with abnormality scores to aid diagnosis, improving clinical workflow for breast cancer screening in women.
Intended Use
Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems.
Technology
The software uses artificial intelligence technology trained via deep learning to automatically analyze DBT slices and generate lesion type, location, lesion-level/case-level scores, and outlines of regions suspicious for breast cancer, providing augmented information to physicians.
Performance
The device underwent software verification and validation per design controls, including software unit and integration testing. A standalone performance study showed an AUROC of 0.931 (95% CI: 0.920-0.941) for breast cancer detection in DBT exams, exceeding the acceptance criteria and demonstrating substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/4/2024
1 month - 2
FDA Approval
10/4/2024
Other devices from Lunit Inc.
- Lunit INSIGHT DBT2023 • 510K
- Lunit INSIGHT MMG2021 • 510K
- Lunit INSIGHT CXR Triage2021 • 510K
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