Abstract
To evaluate cross-platform measurement consistency and diagnostic threshold requirements in shear wave elastography (SWE), this study presents a robotically controlled, phantom-based validation framework to quantify and interpret inter-vendor variability that limits clinical standardisation. A custom-fabricated polyvinyl chloride-graphite phantom containing eight spherical inclusions (15–25 mm diameter, 25–95 mm depth, 23.53–259.58 kPa stiffness), representing breast tissue mechanical properties, was evaluated using Samsung HS50 and Aixplorer ultrasound systems. Robotic automation standardised probe positioning and contact, eliminating operator-dependent variability and enabling direct, system-level comparison. Cross-platform reproducibility, accuracy against mechanically validated ground truth, and diagnostic threshold performance were assessed across 80 measurements. Both systems demonstrated excellent intra-machine reproducibility (coefficient of variation: Samsung 0.42%, Aixplorer 0.46%) with strong inter-machine correlation (r = 0.9951, p < 0.0001). However, systematic bias of 7.05 kPa and 95% limits of agreement spanning 38.7 kPa revealed substantial cross-platform measurement differences. All phantom inclusions (8/8) measured below their assigned ground truth stiffness on both systems, with systematic underestimation ranging from 0.33 kPa to 109.57 kPa, indicating parameter-dependent measurement distortion linked to inclusion size, depth, and stiffness. Dynamic range compression was observed (Samsung: 68.7%, Aixplorer: 59.1% of true phantom range), providing a mechanistic explanation for diagnostic threshold instability. This study contributes an interpretable validation methodology that links SWE measurement bias to physical lesion properties and imaging system characteristics, rather than relying on correlation alone. Despite strong reproducibility, the observed system-dependent bias demonstrates that SWE measurements are not directly transferable across ultrasound platforms, and system-specific collaboration is required to ensure reliable clinical interpretation.
| Original language | English |
|---|---|
| Article number | 214 |
| Number of pages | 13 |
| Journal | Bioengineering |
| Volume | 13 |
| Issue number | 2 |
| Early online date | 13 Feb 2026 |
| DOIs | |
| Publication status | Published - Feb 2026 |
Keywords
- breast imaging
- controlled probe pressure
- cross-vendor comparison
- measurement reproducibility
- phantom validation
- quantitative elastography
- shear wave elastography
- tissue mimicking material
- ultrasound phantom
ASJC Scopus subject areas
- Bioengineering
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