ViewFinder Software Version 1.1
Elaitra LtdViewFinder Software Version 1.1 by Elaitra Ltd is a specialized software tool designed for clinicians to review digital breast tomosynthesis images. It dynamically matches tissue across different breast views using AI to reduce cognitive load, helping radiologists to compare images more efficiently and accurately during breast cancer screening and diagnosis.
Intended Use
ViewFinder is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to support qualified interpreting physicians in both screening and diagnostic reading. It provides visualization and image enhancement tools to aid a qualified interpreting physician in the review of digital breast tomosynthesis datasets.
Technology
ViewFinder Software is a standalone software application or can be integrated into medical image management and processing systems. It simulates tissue movements between views and uses locked Artificial Intelligence algorithms to fine-tune tissue matching between Cranio-Caudal and Medio-Lateral Oblique breast compression views. Runs on PC with monitors cleared for mammography diagnostics.
Performance
Non-clinical integration and functional testing was conducted to meet acceptance criteria based on voluntary standards (ISO 14971, IEC 62304, IEC 82304-1, DICOM). The AI algorithms are locked and trained on large tomosynthesis datasets with expert radiologist annotations, with no overlap between training and test sets. Performance validated using 34 lesions from 30 diverse cases with high prevalence of cancerous and difficult cases, demonstrating accuracy and matching percentages exceeding a 70% threshold. Safety features and risk management per FDA guidelines included.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2022
5 months - 2
FDA Approval
4/21/2023
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