Intended use statement.

MIDI is a radiological computer-aided triage and prioritisation software which is indicated for use in the analysis of brain Magnetic Resonance Images in adults aged 18 and older. The device is intended to assist hospital networks and appropriate trained medical specialists in workflow triage by flagging suspected actionable radiological findings (i.e. an abnormality).

The device uses an artificial intelligence algorithm to analyse images and highlight cases in existing image review and analysis platforms. The abnormality score can classify each scan as normal/abnormal which can be used by downstream hospital systems (such as AI deployment platforms or as a standalone application) to triage/prioritise radiology reporting worklists. For each brain MRI scan a summary document is created which includes a compressed preview image meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Images will continue to be presented to clinicians for review as in existing practice regardless of prioritisation or not.

The results of MIDI are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritisation of medical images. Clinicians are responsible for viewing full images per the standard of care.