IQ-UIP
Imbio, Inc.IQ-UIP is an AI-powered computer-aided software designed to analyze non-contrast chest CT scans to detect and notify specialists about radiological findings suggestive of usual interstitial pneumonia (UIP), a type of fibrotic lung disease. It works alongside standard radiological workflows to help clinicians by providing summarized findings via a worklist application, assisting in the evaluation of interstitial lung disease without altering original images or providing diagnostic conclusions itself.
Intended Use
Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults.
Technology
The device uses an artificial intelligence algorithm to analyze chest CT images and identify positive findings suggestive of UIP. It provides results on a separate worklist application running in parallel to the standard radiological interpretation workflow, without altering the original images. The model was developed using anonymized, multi-center retrospective chest CT data and validated via ground-truthing by expert radiologists.
Performance
Software validation included integration, regression, algorithm validation, design verification, and standalone performance assessment. The device demonstrated an AUC ROC of 96.6%, sensitivity of 90.2%, and specificity of 91.5% on 804 patient images with a prevalence of 24% for UIP pattern. Ground truth was established by five experienced board-certified radiologists.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/20/2024
4 months - 2
FDA Approval
12/19/2024
Other devices from Imbio, Inc.
- Imbio PHA (4.0.0)2024 • 510K
- CAC Software2023 • 510K
- Imbio RV/LV Software2021 • 510K
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