ClariSIGMAM
K203785ClariPi Inc. · cleared 2021-09-10 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems.”
source quote (p.5)
“ClariSIGMAM software is a standalone software application that automatically analyzes "for presentation" 2D digital mammograms to assess breast tissue composition. The software assesses the breast density of women and generates a breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense) in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scale.”
Validation studies (5)
Retrospective clinical
sample size not stated
endpoints: Comparison of ClariSIGMAM-generated breast density estimates with Gold Standard breast density estimates
standards: ISO 14971 Medical devices - Application of risk management for medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
Retrospective clinical
sample size not stated
endpoints: Reproducibility of breast density with age
standards: ISO 14971 Medical devices - Application of risk management for medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
Retrospective clinical
sample size not stated
endpoints: Reproducibility of breast density estimates over time
standards: ISO 14971 Medical devices - Application of risk management for medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
Retrospective clinical
sample size not stated
endpoints: Similarity of breast density estimates for left and right breasts
standards: ISO 14971 Medical devices - Application of risk management for medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
Reader study (MRMC)
n=837 cases
endpoints: Comparison of breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) between experts' visual assessment and automated assessment with ClariSIGMAM
standards: ISO 14971 Medical devices - Application of risk management for medical devices, NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005., Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices issued September 6, 2017.
Reported performance (3 observations)
source quote (p.8)
“Dense 436 87.3%”
source quote (p.8)
“Fatty 293 86.6%”
source quote (p.8)
“n=837; Kappa 0.734 [0.688, 0.781]”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).