AI Metrics
AI Metrics, LLCAI Metrics is a software-based medical imaging tool that helps clinicians view, annotate, and analyze images from multiple modalities and time points. It automates workflow steps in assessing diseases and monitoring response to therapy according to standards like RECIST 1.1, supporting clinical interpretations and documentation in radiology and oncology settings. Importantly, it assists but does not replace the physician's diagnosis process.
Intended Use
AI Metrics is a software solution intended for viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points, supporting anatomical datasets such as CT and MR. It is a workflow automation tool designed for trained medical professionals, aiding in assessing disease extent and therapy response without generating diagnosis.
Technology
AI Metrics is a software-based Picture Archiving and Communication System (PACS) running on Linux platforms, deployed via internet download. It provides tools for manual annotation, semi-automatic lesion segmentation, measurement, labelling, tabulation, and structured reporting based on user-selected standards. It supports DICOM data including anatomical datasets such as CT and MR.
Performance
The software underwent extensive verification and validation testing according to FDA guidance and ISO standards (ISO 62304 for software design, ISO 14971 for risk management, ISO 13485 for quality management). Testing confirmed compliance and acceptable safety and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2020
4 months - 2
FDA Approval
12/22/2020
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