icobrain aria

Standalone

n=199 patients · 100 site(s)

endpoints: Diagnostic performance testing for distinguishing (on the case-level) between no ARIA-E and (mild, moderate or severe) ARIA-E, for distinguishing between no ARIA-H and (mild, moderate or severe) ARIA-H, and for distinguishing between severity levels for ARIA-E and ARIA-H, respectively.; Detection performance, measured as (finding-level) detection rate, false positive rate and misclassification rate (the latter only for ARIA-H) for individual findings (ARIA-E sites of involvement, ARIA-H new microhemorrhages, ARIA-H new areas of superficial siderosis).

standards: IEC 62304:2006/Amd1:2015 Medical device software - Software life cycle processes., ISO 14971:2019 Medical devices - Application of risk management to medical devices., IEC 62366-1:2015/Amd1:2020 - Medical devices - Application of usability engineering to medical devices., Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions, Document issued on September 28, 2022., Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions, Document issued on September 28, 2022., Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document issued on September 27, 2019., Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff, Document issued on: February 3, 2016., General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002., DEN180005 Evaluation of automatic class III designation for OsteoDetect - Decision summary with special controls.

Reader study (MRMC)

n=199 cases

endpoints: The co-primary study endpoints were the difference between assisted and unassisted detection of ARIA-E and ARIA-H (considering in turn either microhemorrhages, superficial siderosis, or both) independently, assessed with the area under the empirical receiver operating characteristic curve (AUC), where the reader assessments for ARIA severity were compared against ground truth obtained via a consensus of 3 experts.; Secondary endpoints evaluated the difference in diagnostic performance of detecting mild ARIA in the subgroup of cases with no and mild ARIA, and in discriminating moderate-or-severe ARIA versus no-or-mild ARIA, for ARIA-E and ARIA-H (considering in turn either microhemorrhages, superficial siderosis, or both), independently.

standards: 21 CFR 892.2090, FDA guidance document "Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data" (issued Sept 2022).