Intended Use

The intended use of EPIQ and Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with multiple clinical indications, including adult cardiac imaging.

Technology

The device incorporates AI-based software applications: 'Smart View Select' uses a deep learning neural network to automatically classify cardiac ultrasound views and select optimal image sets for left ventricle analysis; 'Segmental Wall Motion' uses machine learning algorithms to automatically evaluate regional left ventricle wall motion from multiple apical views and provides segmental scores and a global wall motion score index.

Performance

Performance testing included retrospective studies comparing AI-selected clips to expert manual selection for global longitudinal strain (GLS) and ejection fraction (EF), showing very strong correlation exceeding acceptance criteria, and comparisons of segmental wall motion score index (WMSI) to ground truth with similarly strong agreement. Software validation also included IEC 62304, IEC 62366-1 standards compliance, and risk management.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/27/2024

    28 days
  • 2

    FDA Approval

    4/24/2024

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