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Intended Use

The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases.

Technology

Rapid MLS is a radiological computer-assisted image processing software using AI/ML algorithms within an integrated platform to analyze non-contrast CT images in DICOM format. It outputs annotated images showing differences between expected and measured brain midline, plus a JSON report with quantitative measurements.

Performance

The device was validated using 153 NCCT cases with ground truth established by 3 experts, showing a mean absolute error (MAE) of 0.7 mm versus experts' 1.0 mm, demonstrating non-inferiority. Validation included diverse scanner manufacturers and multiple clinical sites, confirming accurate performance under clinically relevant conditions.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/30/2024

    7 months
  • 2

    FDA Approval

    5/28/2025

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