Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

The Aplio i900/i800/i700 Diagnostic Ultrasound System with Software V6.5 aims to provide comprehensive, high-quality diagnostic imaging across a multitude of clinical specialties by leveraging advanced ultrasound technology, diverse imaging modes, and AI-enhanced analytical tools. This software iteration focuses on expanding diagnostic capabilities through new features like Tissue Shift Tracking and refining existing functionalities for improved image quality, workflow efficiency, and data management.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, with its Software V6.5, is designed for the visualization of anatomical structures and dynamic physiological processes within the human body to provide diagnostic image information across a wide array of clinical applications. These applications include fetal, abdominal, intra-operative, pediatric, small organs (thyroid, breast, testicle), trans-vaginal, trans-rectal, neonatal and adult cephalic, cardiac (adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal, laparoscopic, and Thoracic/Pleural imaging. The system employs ultrasound technology, utilizing a variety of probes (flat linear array, convex, sector array) with frequencies from approximately 2MHz to 30MHz, and offers numerous imaging modes such as B-mode, M-mode, Doppler (Continuous Wave, Color, Pulsed Wave, Power, Combination), Speckle-tracking, Tissue Harmonic Imaging, Shear Wave elastography, general Elastography, and Acoustic Attenuation Mapping. This Software V6.5 represents a modification to a previously existing device, introducing new functionalities and enhancing established ones. A key new feature is 'Tissue Shift Tracking,' which uses existing color mapping to visualize calculated parameters. Improvements to existing features include enhanced 'Network Storage' for raw data, 'Tricefy Access' for DICOM data transfer through firewalls, expanded availability of 'Attenuation Imaging' and 'Dispersion Map for SWE' to linear transducers, extended 'Smart Body Mark' for abdominal use, an increased upper limit for 'SWE Hard' (shear wave elastography), a new 'Lung Preset', 'iBeam+' with 'Full Focus' capability, 'Apligate' and 'Apligate Soft' for de-identified image sharing, and new 'Breast Package' options. Additionally, marketing language has been expanded for features supported by artificial intelligence (AI) and machine learning (ML), specifically the automated contour tracing in 2D Wall Motion Tracking (2D WMT) and Auto Ejection Fraction (Auto EF). Performance testing using phantoms, test data, and volunteer data confirmed that these new and improved features meet established specifications and perform as intended; no new clinical studies were required.

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 'Tissue Shift Tracking' feature quantitatively improve diagnostic accuracy or efficiency in its intended clinical applications compared to existing imaging techniques?; What are the specific performance benchmarks (e.g., accuracy, processing time) for the AI/ML-supported '2D WMT with Full-assist' and 'Auto EF with Full-assist' functions, and how were these validated across diverse patient datasets?; Can the expanded range of the 'SWE Hard' feature for shear wave elastography lead to better differentiation of highly stiff tissues, and what evidence supports its utility in challenging cases?; What are the measurable improvements in image resolution, penetration, or artifact reduction provided by 'iBeam+ with Full Focus' compared to the previous iBeam+ iteration, particularly in deep tissue imaging or for specific transducer types?; Considering the enhanced data transfer capabilities like 'Tricefy Access' and 'Network Storage', what specific cybersecurity protocols and data encryption methods are implemented in Software V6.5 to ensure patient data privacy and system integrity?