Sonio Detect
Sonio • Radiology • 07/25/2023
Device Purpose
Sonio Detect is an AI-powered, cloud-based software designed to enhance fetal ultrasound examinations by automatically detecting views, anatomical structures, and verifying image quality criteria in real-time. Its methodology combines machine learning, biometric analysis, and colorimetry to provide a concurrent reading aid for healthcare professionals, aiming to improve the completeness and standardization of obstetric ultrasound assessments.
Summary
Sonio Detect is a Software as a Service (SaaS) solution designed to assist healthcare professionals, including sonographers, OB/GYNs, Maternal-Fetal Medicine specialists, and fetal surgeons, in performing routine fetal ultrasound examinations in real-time across all trimesters (gestational age 11 to 37 weeks). Its primary function is to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect standard obstetric views, identify anatomical structures within these views, and verify predefined quality criteria. The system operates by receiving DICOM instances from compatible ultrasound machines (GE, Canon, Samsung) via a locally installed Edge Software, which uploads the data to Sonio's cloud platform for processing; Sonio Detect's algorithm leverages artificial intelligence, biometric analysis from images, and colorimetry for 3D and Doppler images to provide concurrent reading support, aiming to ensure examination completeness and adherence to imaging protocols. The software highlights any unverified views or quality criteria, such as the presence or absence of specific anatomical structures (e.g., cavum septum pellucidum, cerebellum, heart chambers, major vessels) or correct zoom levels, allowing users to review and override the system's automated assessments. Quality criteria checked include the presence of key brain structures like the cavum septum pellucidum and cerebellum, and heart components like ventricles, atria, and major vessels. Performance testing on a dataset of 17,885 fetal ultrasound images demonstrated high sensitivity and specificity across various detection tasks: view detection (e.g., T1 views sensitivity 0.942, T2/T3 views sensitivity 0.919), anatomical structure identification within brain (sensitivity 0.857, specificity 0.963) and heart views (sensitivity 0.900, specificity 0.982), and verification of zoom levels for brain views (sensitivity 0.952, specificity 0.906). The system also showed high sensitivity in detecting 3D (0.980) and Doppler (0.963) images.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does the 'Lecture of biometrics' and 'Colorimetry identification' component of the algorithm specifically improve performance beyond standard AI techniques for fetal ultrasound analysis?; What is the range of variability in performance when Sonio Detect is used with different compatible ultrasound machines (GE, Samsung, Canon) under real-world clinical conditions?; What is the learning curve for healthcare professionals to effectively use Sonio Detect, including the override functionality, and integrate it into their existing workflow?; How does the system handle ambiguous or poor-quality ultrasound images, and what is the threshold for when it cannot provide a confident detection or quality assessment?; Are there plans to expand the list of automatically detected views, anatomical structures, or quality criteria, particularly for more complex fetal anomalies or later gestational stages?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of ML-BOM, SaaSBOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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