Constellation (CON-001)
Q Bio, Inc.Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.
Intended Use
Non-invasive labeling and calculation of quantitative measurements for anatomical regions from whole-body MRI images of healthy adult patients.
Technology
Automated image post-processing software that stitches together overlapping MR images from multiple stations, uses non-AI based algorithms and convolutional neural networks for segmentation of several anatomical structures, and outputs quantitative measurements with alpha-blended color label overlays in PDF format.
Performance
Performance evaluation included segmentation accuracy assessed by Dice Similarity Coefficient and mean percent absolute difference, majority voting by radiologists for liver VOI placement, repeatability testing, inter- and intra-rater variability studies, and software verification and usability testing. Results showed the device performs as intended without new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/7/2024
4 months - 2
FDA Approval
9/12/2024
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