See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte. Ltd.See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is an AI-powered software that assists medical professionals in analyzing thyroid ultrasound images by automatically localizing thyroid nodules and characterizing them using standardized descriptors based on ACR TI-RADS. It helps clinicians generate structured reports and improves accuracy in detection and classification of nodules, thereby supporting clinical decision-making in thyroid nodule management.
Intended Use
Localization and characterization of thyroid ultrasound images in adult patients referred for ultrasound examination.
Technology
Stand-alone, web-based image processing and reporting software that uses machine learning algorithms to localize suspicious thyroid nodules and classify them according to ACR TI-RADS descriptors. Produces reports reviewed and approved by clinicians. Runs on standard computers with DICOM-compliant ultrasound images as input.
Performance
Clinical performance evaluated in a Multi-Reader Multi-Case (MRMC) study with 18 radiologists reading 600 cases, showing improved reader performance with device aid in localization, lexicon characterization, and TI-RADS agreement. Standalone performance comparable to aided read. Non-clinical software validation and risk analysis done per recognized standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/14/2024
5 months - 2
FDA Approval
9/9/2024
Other devices from See-Mode Technologies Pte. Ltd.
- AVA (Augmented Vascular Analysis)2020 • 510K
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