REAL-WORLD SAFETY AND PERFORMANCE OF THE COLOR DOPPLER ULTRASOUND SYSTEM: A MULTI-CENTER POST-MARKET CLINICAL FOLLOW-UP SURVEY
Keywords:
Post-market clinical follow-up, Ultrasound, Real-world evidence, Safety, Performance, Acceptability ratesAbstract
Objective: To evaluate the real-world clinical safety and performance of the Color Doppler Ultrasound System (Model: M30/ViV 20, Manufacturer: Zoncare, China) across multiple centers and diverse operator profiles. Methods: This cross-sectional PMCF survey enrolled evaluators from 61 centers. A standardized questionnaire was used to assess device safety and performance across four domains: Safety (2 items), Image Quality (6 items), Operational Experience (4 items), and Stability (3 items). The primary endpoint was the acceptability rate (dichotomized as "Acceptable" vs. "Not acceptable") for each indicator, with exact 95% confidence intervals (CIs) calculated. The secondary endpoint comprised the distribution of original ordinal responses (Likert-scale) and median scores for each item. Results: A total of 76 valid questionnaires were returned. For the primary endpoint, the safety incidence (electric shock/skin burns) was 0% (95% CI: 0.0% - 4.7%). The overall acceptability rates for Image Quality, Operational Experience, and Stability were 99.3% (95% Bootstrap CI: 98.5% - 100.0%), 99.3% (95% Bootstrap CI: 98.3% - 100.0%), and 98.7% (95% Bootstrap CI: 97.0% - 100.0%), respectively, all exceeding the pre-defined performance goal of 84.4%. Secondary analysis revealed that the median scores for most items fell within the "High/Excellent" range (e.g., Resolution: 3 [IQR: 2-3]), indicating a generally positive perception. Detailed ordinal distributions highlighted that for image quality, focus and noise received the highest proportion of "Excellent" (Accurate/Low) ratings (89.5% and 81.6% respectively); for operational experience, button comfort rated best (65.8% Excellent); for stability, changes in device or probe performance rated best (85.5% Stable). Conclusion: The Color Doppler Ultrasound System demonstrates robust safety and high performance in real-world clinical settings, meeting the pre-specified performance criteria. Secondary analyses provided granular insights into specific strengths and minor areas for future optimization.References
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