EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLCThe EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound machines designed for diagnostic imaging and fluid flow analysis of the human body. They include a new AI-powered Smart Doppler View ID feature that automatically navigates and selects the appropriate Doppler measurement groups on the touchscreen interface, enhancing clinician workflow and reducing manual navigation during cardiac ultrasound exams. This helps clinicians focus on key Doppler measurements efficiently during cardiac assessments.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body, including cardiac adult and various other anatomical indications.
Technology
The system uses diagnostic ultrasound imaging technology with pulsed doppler modes and an AI-based Smart Doppler View ID software feature. The AI algorithm analyzes acquired Doppler spectrums to automatically highlight the corresponding Doppler Calculation Package group on the touchscreen, assisting navigation and workflow but not performing measurements. The feature supports various transducers and runs on EPIQ and Affiniti systems with software version 11.0 or higher.
Performance
Non-clinical verification tests and software validation were performed, showing the AI algorithm achieved 97.5% accuracy (95% CI 96.3%-98.3%, p < 0.0001) in matching user-verified ground truth touchscreens for Doppler measurements using a clinical dataset of 1100 clips from 400 patients with diverse demographics. No new hardware or measurements were introduced, only workflow automation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/28/2023
2 months - 2
FDA Approval
2/13/2024
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