ClariSIGMAM

ClariPi Inc.

The ClariSIGMAM is a breast density assessment solution that provides density estimates from standard digital mammograms. It automatically analyzes 2D digital mammograms to calculate breast tissue composition. It assesses breast density and generates a breast density grade in line with the American College of Radiology’s BI-RADS density classification scales. The breast density output by ClariSIGMAM is designed to display on mammography workstations or PACS as a DICOM mammography structured report or secondary capture.

Information source: Vendor
Last updated: Oct. 4, 2023

General Information

General
Product name	ClariSIGMAM
Company	ClariPi Inc.
Subspeciality	Breast
Modality	Mammography
Disease targeted	Breast cancer
Key-features	Breast density assessment according to BIRADS 5th edition
Suggested use	During: interactive decision support (shows abnormalities/results only on demand), report suggestion

Technical Specifications

Data characteristics
Population	Anyone who requires mammography exam
Input	Digital mammography images for presentation, RCC, LCC, RMLO, LMLO
Input format	DICOM
Output	Report for each breast: • Area of fibroglandular tissue (cm²) • Area of breast (cm²) • Area-based breast density (%) For each patient: • Breast density group information for the patient (BI-RADS)
Output format	DICOM
Technology
Integration	Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration CIS (Clinical Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis	Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	3 - 10 seconds

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	ClariSIGMAM is a standalone software application that automatically analyzes digital mammograms to calculate breast density. The software runs on an “off-theshelf” computer and can be used to perform image viewing, processing and analysis of medical images. Image data are acquired through DICOM compliant imaging devices and modalities. Digital mammograms are transferred from the digital mammography system to ‘DICOM Receiver’ module through the DICOM Storage SCP protocol using DICOM communication standard. Then, the ‘Breast Density Analyzer’ module performs breast density analysis of the received digital mammograms. Finally, ‘DICOM Sender’ module transfers the breast density analysis report to the PACS system through DICOM Storage SCU protocol. ClariSIGMAM is a software application intended for use with compatible full field digital mammography (FFDM) systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with BI-RADS breast density category according to 4th and 5th edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.

Market

Market presence
On market since	09-2021
Distribution channels	Calantic, Blackford, deepcOS, Eureka Clinical AI
Countries present (clinical, non-research use)	1
Paying clinical customers (institutes)	8
Research/test users (institutes)	5
Pricing
Pricing model	Pay-per-use, Subscription, One-time license fee
Based on	Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Reliability of Computer-Assisted Breast Density Estimation: Comparison of Interactive Thresholding, Semiautomated, and Fully Automated Methods (read) A novel deep learning-based approach to high accuracy breast density estimation in digital mammography (read)
Non-peer reviewed papers on performance
Other relevant papers