Real World Evaluation of Lunit INSIGHT MMG Technology

The study has three main objectives, which will be met through separate sub-studies and analyses. First, it will investigate and compare the performance of the Lunit INSIGHT MMG tool in combination with a human reader, against the current standard of care (two human readers). Quantitative data will be collected from a prospective, observational cohort study which will take place during routine clinical care at the participating site in parallel to standard care. The main aims will be: 1. To assess and compare the sensitivity and specificity of Lunit INSIGHT MMG combined with a single human reader for non-inferiority compared to double human reading 2. To assess and compare the rate of escalation to arbitration (following non-agreement) for non-inferiority of Lunit INSIGHT MMG combined with a single human reader against double human reading 3. To assess clinician reported agreement with the Lunit INSIGHT MMG report 4. To address any differences in performance characteristics as a function of patient age 6 To assess how Lunit score relates to tumour grade on biopsy Second, the acceptability and perceptions surrounding the AI will be investigated using qualitative data obtained from patient and workforce interviews and questionnaires from the latter. The main aims will be to assess the acceptability of the Lunit INSIGHT MMG tool to patients and the workforce and explore patient and workforce perceptions surrounding it and its implementation in clinical pathways. Third, a health economic evaluation will be carried out in a cost effectiveness analysis to assess the value of introducing the Lunit INSIGHT MMG tool at a "one-stop" breast clinic. The main aims will be two. The implementation costs of the Lunit Insight MMG tool and costs of a scan read by it, in combination with a human reader, will be compared against the cost of double human readings based on standard practices. In addition, a valuation of outcomes will also be undertaken following the lifetime of the cohort with the use of the Lunit INSIGHT MMG tool compared with standard of care.