Jazz
AI Medical AGJazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.
Intended Use
Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.
Technology
Jazz is a Software as a Medical Device (SaMD) using semi-automatic processing pipelines for MR images. It performs image coregistration, contrast recognition, optional pre-annotation of abnormalities by various algorithms, and allows the physician to review and correct segmentations before finalizing the report. The software outputs radiological reports in formats like text, PDF, and DICOM.
Performance
The device performance was validated for accuracy and reproducibility against expert manual labeling on 344 subject datasets including healthy subjects, multiple sclerosis and metastasis patients. Accuracy acceptance criteria for sensitivity, specificity, lesion-wise dice scores, anatomy localization, and coregistration quality were met. Reproducibility was demonstrated with consistent lesion counts, volumes, and report generation in test-retest experiments. System verification confirmed device capabilities for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/6/2022
9 months - 2
FDA Approval
9/22/2023
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