Caption Guidance
Caption HealthCaption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.
Intended Use
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. It is an accessory to compatible general purpose diagnostic ultrasound systems and indicated for use in 2D transthoracic echocardiography (2D-TTE) for adult patients to acquire specific echocardiographic views.
Technology
Caption Guidance is a software-only radiological acquisition guidance system utilizing AI to provide real-time user feedback and prescriptive guidance mimicking expert sonographer maneuvers. Features include a quality meter, prescriptive guidance, auto-capture of quality clips, and retrospective best clip saving, all aimed at optimizing cardiac ultrasound image acquisition.
Performance
The device underwent rigorous software verification and validation including algorithm development, testing on separate data sets, and human factors testing with both experienced and novice users. Testing showed robust performance of auto-capture and prescriptive guidance features, with no use errors leading to patient injury, demonstrating substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/23/2020
24 days - 2
FDA Approval
4/16/2020
Other devices from Caption Health
- Caption Interpretation Automated Ejection Fraction Software2023 • DE NOVO
- Caption Interpretation Automated Ejection Fraction Software2022 • 510K
- Caption Guidance2020 • 510K
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