MEDO-Thyroid
MEDO DX Pte. Ltd.MEDO-Thyroid is a cloud-based software that uses machine learning to help radiologists evaluate ultrasound images of the thyroid. It assists in measuring thyroid lobes and nodules, supports diagnosis by providing volume measurements and TI-RADS classification, and generates reports, improving the efficiency and accuracy of thyroid image assessment for adult patients.
Intended Use
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
Technology
MEDO-Thyroid is a cloud-based standalone software as a medical device (SaMD) that imports DICOM ultrasound images, enabling users to upload, view, measure thyroid lobes and nodules volumes, place landmarks manually or semi-automatically, apply TI-RADS classification based on user input, and generate reports. It supports multi-frame visualization and cross-referencing to assist radiologists.
Performance
Performance was validated through software verification and validation testing according to IEC 62304 and FDA guidance, using ultrasound images from Philips, GE, and Siemens devices. Performance results showed high intraclass correlation coefficients (around 0.97) for thyroid lobe and nodule volume measurements, with maximum percentage volume errors generally below 25% across the tested ultrasound devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/30/2020
4 months - 2
FDA Approval
4/23/2021
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