Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

The Aplio i900/i800/i700 Diagnostic Ultrasound System with Software V7.0 aims to enhance diagnostic imaging across diverse clinical applications by utilizing multi-modal ultrasound technology. Its updated software incorporates deep learning algorithms to automate and streamline cardiac assessments, specifically improving workflow efficiency and quantitative analysis through features like automated plane detection and Doppler waveform tracing, validated for accuracy and time-saving benefits.

The Aplio i900/i800/i700 Diagnostic Ultrasound Systems, with Software V7.0, are mobile devices designed for visualizing internal body structures and dynamic processes to aid in diagnosis across a wide spectrum of clinical applications. These applications include fetal, abdominal, pediatric, cardiac, vascular, musculoskeletal, and small organ imaging, among others. The systems utilize various ultrasound probes (linear, convex, sector arrays) operating between approximately 2MHz and 33MHz to generate high-quality images in multiple modes such as B-mode, M-mode, Doppler (Color, Pulsed Wave, Continuous Wave, Power), Speckle-tracking, Tissue Harmonic Imaging, Shear wave, Elastography, and Acoustic attenuation mapping. They are intended for use by trained medical professionals in hospital and clinical environments. Software V7.0 introduces significant enhancements, primarily leveraging deep learning methodologies to improve cardiac assessment workflows and efficiency. Key new features include Auto Plane Detection for automatic selection of standard cardiac views (A4C, A2C, A3C, SAX) with over 90% agreement with expert sonographers; Quick Strain, which, when used with Auto Plane Detection, reduces wall motion tracking operation time by an average of 68% while maintaining result accuracy for EDV, ESV, EF, and GLS. Furthermore, Auto LVOT and Auto AoV features automate the tracing of LVOT and aortic valve Doppler waveforms, respectively, reducing operation times by approximately 78% and 71% without compromising measurement precision compared to manual methods. The software also expands 2D Wall Motion Tracking capabilities to the right ventricle and right atrium. Validation studies on U.S. clinical patient data confirmed these features perform effectively across diverse patient demographics and disease severities, meeting predefined acceptance criteria for accuracy and workflow improvement.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the performance of the Auto Plane Detection feature vary in patients with atypical cardiac anatomy or rare pathologies not extensively represented in the validation dataset?; What is the learning curve for sonographers to effectively utilize and trust the new automated features like Auto LVOT and Auto AoV, and how does it impact overall exam consistency across different users?; Beyond time savings, what is the quantifiable impact of Quick Strain on inter-observer variability for measurements like EF and GLS compared to the conventional WMT workflow?; Are there specific patient populations or image quality scenarios where the deep learning algorithms for Auto Plane Detection, Auto LVOT, or Auto AoV show reduced accuracy or require manual override more frequently?; Given the expansion of Wall Motion Tracking to the right ventricle (2D WMT RV) and right atrium (2D WMT RA), what new diagnostic insights or prognostic capabilities are anticipated from these extended functionalities?