Lumify Diagnostic Ultrasound System
Philips UltrasoundThe Philips Lumify Diagnostic Ultrasound System is a portable ultrasound device used by healthcare professionals to capture high-resolution ultrasound images and perform fluid flow analysis in various clinical applications including cardiac imaging. It incorporates an AI-based Auto EF Quantification feature that automatically assesses cardiac function by measuring the left ventricle’s ejection fraction, improving clinical workflows during cardiac examinations.
Intended Use
The Philips Lumify Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetric, abdominal, pediatric, cephalic, urology, gynecological, cardiac fetal echo, small organ, musculoskeletal, peripheral vessel, carotid, cardiac, and lung applications.
Technology
The system uses a commercial off-the-shelf Android or iOS device coupled with Philips Lumify software and a variety of ultrasound transducers to acquire ultrasound data. The AI Auto EF Quantification feature is based on the LVivo EF algorithm and provides automated measurement of left ventricular ejection fraction, end diastolic volume, and end systolic volume from apical four-chamber views, including automatic tracing and tracking of left ventricle borders with editing and error rejection capabilities.
Performance
Non-clinical verification testing including functional testing, risk analysis, and design reviews were conducted to ensure safe and effective performance of the software change with the Auto EF feature. A clinical performance study using 80 patients showed strong correlation (r=0.82 for EF) between automated AI measurements and manual tracing by sonographers, with 95% successful clip processing. There was no clinical investigation needed beyond this study.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/17/2023
2 months - 2
FDA Approval
10/26/2023
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