EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems with AutoMeasure V3 software provide semi-automated 2D, Doppler, and M-mode cardiac measurements during transthoracic echocardiography. The AutoMeasure V3 feature uses artificial intelligence and machine learning to automatically initialize measurement calipers, which operators can then edit, accept, or reject based on clinical judgment.

AutoMeasure V3 is functionally identical to the predicate AutoMeasure software in workflow and semi-automation methodology. The key difference is expansion from 2D and Doppler measurements to include M-mode measurements (TAPSE), addition of new detectors (e.g., RA Volume, AoR Diam), and re-training of existing detectors based on updated clinical literature. No hardware changes were made.

IEC 62304 (Medical device software – Software life cycle processes, 2006 + A 2015) and ISO 14971 (Medical devices – Application of risk management to medical devices, 2019). The device also complies with the FDA's February 2023 guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

A performance validation study of 7,127 TTE cardiac clips from 3,964 diverse subjects (age 18–100, multiple races/genders, varied BMI) demonstrated that AutoMeasure V3 measurements achieved high agreement with ground-truth Standard of Care measurements across all 32 hypotheses tested, with confidence intervals meeting pre-defined acceptance criteria. Because acceptance criteria were based on inter-observer echocardiographic data, AutoMeasure V3 performance is equivalent to average human observer variability. Since the software-only modification preserves the same semi-automated AI-based architecture and workflow of the predicate, and new measurements/detectors are additive extensions with validated performance, the device does not raise new safety or effectiveness questions and remains substantially equivalent.