UltraSight AI Guidance
UltraSight Inc.UltraSight AI Guidance is a mobile AI-based application that helps non-expert medical professionals acquire high-quality cardiac ultrasound images by providing real-time guidance on how to position and manipulate the ultrasound probe for standard transthoracic echocardiography views. It enhances image acquisition quality and enables better diagnosis even by novice users.
Intended Use
The UltraSight AI Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. It is an accessory to compatible general-purpose diagnostic ultrasound systems, indicated for two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically for ten standard cardiac views.
Technology
The device is a mobile AI software application running on tablets interfacing with cleared ultrasound systems, using deep learning-based algorithms to analyze ultrasound images and provide real-time dynamic guidance on probe position and orientation to users. It delivers a quality bar score and graphical probe manipulation cues based on classification of images and probe pose to help non-expert users acquire diagnostic-quality cardiac images.
Performance
Performance testing included software verification and validation per IEC 62304, standalone AI algorithm testing with over 5 million ultrasound frames and thousands of clips for quality scoring, view detection, and probe guidance accuracy, achieving high AUC values (>0.8). Human factors validation confirmed safe and effective usability by non-expert users. Clinical studies with non-experts demonstrated high rates (93-100%) of diagnostic quality cardiac ultrasound acquisitions comparable to expert sonographers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/1/2022
8 months - 2
FDA Approval
7/24/2023
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