AmCAD-UT
AmCad BioMed CorporationAmCAD-UT is a Windows-based AI-assisted software designed to help clinicians analyze thyroid ultrasound images. After initial review by a physician, the software quantifies and visualizes sonographic features of thyroid nodules, specifically those larger than 1cm, aiding in clinical decision-making for biopsy recommendations. It facilitates detailed image analysis and generates automated reports to support thyroid cancer diagnosis and management.
Intended Use
AmCAD-UT is a Windows-based computer-aided detection device intended to assist medical professionals in analyzing thyroid ultrasound images from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. The device provides detailed quantification and visualization of sonographic characteristics of nodules larger than 1cm, aiding biopsy recommendations.
Technology
The device uses AI contouring algorithms to define ROI on thyroid ultrasound images, quantifies sonographic features such as hyperechoic foci, echogenicity, texture, margin, orientation, and anechoic areas, and automatically generates detailed reports in PDF format. It operates on Windows platforms using standard PC hardware.
Performance
Performance testing included standalone validation of the AI-suggested ROI contouring on user-selected nodules from FDA-cleared ultrasound images, showing effective contour determination. The device poses no new safety or effectiveness concerns compared to its predicate.
Predicate Devices
No predicate devices specified
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