NinesMeasure
Nines, Inc.NinesMeasure is a software tool designed to help trained radiologists measure the size of pulmonary nodules on adult thoracic CT scans. It uses artificial intelligence to automatically calculate long and short axis diameters of nodules, providing quantitative information for better assessment and tracking over time. This tool assists clinicians by streamlining nodule measurement, though it is not intended to replace full patient evaluation or diagnosis.
Intended Use
NinesMeasure is a semi-automatic tool indicated for use by trained radiologists to aid in the analysis and review of adult thoracic CT images. It provides quantitative information about pulmonary nodule size on a single study or over several studies by providing long and short axis diameter measurements in the axial plane. It uses AI algorithms to automatically perform measurements based on radiologist input indicating nodule location, and is limited to solid pulmonary nodules. It is a measurement tool and does not alter the original image or replace full patient evaluation.
Technology
NinesMeasure is a software system comprised of AI-based image processing modules that receive DICOM chest CT images and supplied coordinates of pulmonary nodules from a radiologist, then automatically compute and return long and short axis diameter measurements for review. It operates over a network interface and integrates with standard PACS systems. The core technology is a machine learning algorithm that segments nodules from CT images to derive measurements similar to a predicate device.
Performance
The software underwent verification and validation testing to evaluate algorithm performance and overall software function. A multi-center retrospective study demonstrated that NinesMeasure met primary endpoints for normalized measurement errors on long and short axis diameters across nodules of various sizes, establishing performance consistent with its predicate device and acceptable safety and effectiveness profiles.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2020
4 months - 2
FDA Approval
2/25/2021
Other devices from Nines, Inc.
- NinesAI2020 • 510K
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