EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLCThe Philips EPIQ Inspira and Affiniti Series are advanced ultrasound systems used for imaging many parts of the body. A key AI-powered feature, 2D Auto LA, helps clinicians quickly and accurately measure the size and function of the left atrium in the heart during routine echocardiography exams, supporting efficient and consistent cardiac assessments while allowing clinicians to review and adjust results.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body, with support for multiple clinical applications including adult cardiac imaging. The 2D Auto LA feature specifically assists in automated quantification of left atrial size and function in adult transthoracic echocardiography.
Technology
The system is a general-purpose, software-controlled diagnostic ultrasound platform. The 2D Auto LA feature is AI-assisted, providing automated detection of left atrial endocardial borders (using previously cleared AI-based contour detection) and speckle tracking-based strain analysis, allowing for biplane volume and strain measurements. Users maintain supervisory control to edit and verify all automated measurements.
Performance
Nonclinical verification was conducted according to IEC and ISO standards for medical devices, covering hardware, software, and risk management. Clinical performance was validated in a retrospective study of 217 adult echocardiography exams, showing that the AI-based feature met predefined accuracy criteria for left atrial volume and strain compared to qualified human assessors, supporting its safety and effectiveness.
Predicate Devices
No predicate devices specified
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