AmCAD-UO
AmCad BioMed CorporationAmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.
Intended Use
AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system, providing visualization and quantification of airway characteristics to support evaluation and monitoring of airway status.
Technology
AmCAD-UO uses statistical pattern recognition and quantification methods to analyze upper airway ultrasound images. It supports manual or interactive region selection to quantify size, position, and enhancement patterns in ultrasound images.
Performance
Performance testing included software verification and validation, software unit and integration testing, phantom image tests for ROI identification, and limited clinical assessment comparing measurements to MRI. Results show good correlation, with caveats due to small sample size and different imaging modalities. The device is safe and effective for its intended use.
Predicate Devices
No predicate devices specified
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