Mia (version 2.0.1) – Kheiron Medical Technologies
2026-01-24https://doi.org/10.1148/atlas.1769270370823
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Overview
Schema Version
https://atlas.rsna.org/schemas/2025-11/model.json
Name
Mia (version 2.0.1) – Kheiron Medical Technologies
Link
https://pmc.ncbi.nlm.nih.gov/articles/PMC10245180
Indexing
Keywords: Breast, Screening, Mammography, Computer Applications–Detection/Diagnosis, Neoplasms-Primary, Technology Assessment
Content: BR
RadLex: RID10519, RID50114, RID10357
Author(s)
Clarisse F. de Vries
Samantha J. Colosimo
Roger T. Staff
Jaroslaw A. Dymiter
Joseph Yearsley
Deirdre Dinneen
Moragh Boyle
David J. Harrison
Lesley A. Anderson
Gerald Lip
Organization(s)
University of Aberdeen
NHS Grampian (NHSG)
Kheiron Medical Technologies
University of St Andrews
iCAIRD – Industrial Centre for Artificial Intelligence Research in Digital Diagnostics
Canon Medical Research Europe – SHAIP platform
Grampian Data Safe Haven (DaSH)
Version
2.0.1
Contact
Corresponding author: Clarisse F. de Vries, email: ku.ca.ndba@seirved.essiralc (as presented in article)
Funding
Supported by the Industrial Centre for Artificial Intelligence Research in Digital Diagnostics (iCAIRD), funded by Innovate UK on behalf of UK Research and Innovation (UKRI) (project no. 104690).
Ethical review
Approved by Proportionate Review Subcommittee of the London-Bloomsbury Research Ethics Committee (20/LO/0563); Public Benefit and Privacy Panel approval (1920–0258). Secondary use of de-identified data; individual consent not required.
Date
Published: 2023-03-22
References
[1] Sharma N, Ng AY, James JJ, et al.. "Large-scale evaluation of an AI system as an independent reader for double reading in breast cancer screening". medRxiv 2021.02.26.21252537 [preprint]. 2021-03-01. doi:10.1101/2021.02.26.21252537.
Model
Architecture
Ensemble of deep learning algorithms producing a continuous malignancy prediction value (0–1) from four standard mammography views.
Availability
Commercial product (Mia), Conformité Européenne (CE) marked per article.
Clinical benefit
Assists breast cancer screening by identifying exams to recall; detected more cancers than single human reader in study setting and flagged a subset of interval cancers.
Clinical workflow phase
Clinical decision support within population breast screening (triage/decision support alongside human readers).
Decision threshold
Vendor-prespecified threshold ≥0.1117 indicates recall; site-specific thresholds calibrated for local site and mammography unit software versions (0.2712 pre-upgrade; 0.4319 post-upgrade).
Degree of automation
Decision support; outputs a recall/no-recall recommendation based on threshold and a malignancy score; recommended to be combined with human reader input.
Indications for use
Assessment of routine screening full-field digital mammography in women approximately 50–70 years attending the U.K. breast screening program in a clinical screening environment.
Input
Four standard mammography images per exam (bilateral CC and MLO full-field digital mammography).
Instructions
Validate and calibrate decision thresholds locally before deployment; monitor performance through quality assurance; consider per–mammography software-version thresholds.
Limitations
Performance and recall rates were affected by mammography equipment/software version; prespecified threshold did not transfer, causing high recall rates; evaluated on a single-center, predominantly White population; higher false-positive rate than routine dual reading; generalizability requires validation.
Output
CDEs: RDE858, RDE1586
Description: Continuous malignancy prediction value (0–1) and a binary recall recommendation when compared against a decision threshold.
Recommendation
Perform local retrospective evaluation and threshold calibration; implement ongoing quality assurance and monitor for consistency across equipment/software versions.
Regulatory information
Comment: Thresholds and malignancy scores provided by vendor; algorithm version unchanged during study; equipment software versions affected AI performance.
Authorization status: CE marked (indicating compliance with applicable EU regulations).
Use
Intended: Detection and diagnosis
Out-of-scope: Detection and diagnosis
Excluded: Exam protocol selection
User
Intended: Radiologist, Subspecialist diagnostic radiologist