EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound LLCThe EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are sophisticated diagnostic ultrasound devices that integrate deep learning AI technology to assist clinicians in cardiac imaging. Their Smart View Select software automatically classifies and selects optimal ultrasound images for left ventricle analysis in echocardiography, enhancing workflow and diagnostic accuracy for cardiac assessment. These systems are used by trained healthcare professionals in clinics and hospitals for a broad range of diagnostic ultrasound applications.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body across multiple anatomical regions including cardiac (adult, fetal, pediatric), abdominal, musculoskeletal, and others.
Technology
Smart View Select (SVS) is an automated software application integrated into the ultrasound systems that uses a deep learning AI neural network to classify acquired ultrasound images by cardiac view and select optimal sets of clips (A4C, A2C, A3C) for left ventricle analysis. The selection algorithm also uses heuristic logic based on scan depth.
Performance
Performance testing included retrospective data analysis comparing manual expert selection of ultrasound clips and subsequent left ventricle function analysis (GLS and EF) with the AI-selected clips and AutoStrain LV software outputs. Results showed very strong correlation (Pearson correlation coefficients ~0.89 for EF and ~0.91 for GLS), meeting acceptance criteria for substantial equivalence and demonstrating safety and effectiveness of the AI feature. Additional software lifecycle and risk management testing was performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/25/2025
2 months - 2
FDA Approval
6/18/2025
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