THINQ
CorticoMetrics LLCTHINQ is a medical imaging software device designed to automatically segment, label, and measure volumes of brain structures from 3D T1-weighted MRI scans. It provides clinicians with visual and quantitative reports comparing brain volumes to reference data, helping in the assessment of neurological conditions by automating brain morphometry.
Intended Use
THINQ is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. It automates the manual process of identifying, labeling, and quantifying brain structure volume.
Technology
THINQ is a software-only, non-interactive application running on off-the-shelf hardware. It uses atlas-based segmentation with automated quality control steps and outputs a quantitative morphometric report in PDF and segmentation overlays in DICOM JPEG format. It operates as a container in high-performance computing environments.
Performance
Performance testing included accuracy validation with expert-labeled brain segments using Dice similarity and absolute/relative volume errors, showing good accuracy and reproducibility across multiple brain structures. Testing used 645 MR images representing a diverse set of patient and imaging characteristics. Quality system standards including 21 CFR part 820 and ISO standards were followed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/31/2019
1 year, 2 months - 2
FDA Approval
9/30/2020
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