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ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.

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. Output of breast density by ClariSIGMAM is designed to display on a mammography workstation or PACS as DIOCM mammography structured report or secondary capture. The reports are configured to provide the following data: Breast area (cm²) for each breast, Fibroglandular tissue area (cm²) for each breast, Percent breast density for each breast, Breast density group information for the patient (BI-RADS A+B as fatty and BI-RADS C+D as dense).

Here's a breakdown of the acceptance criteria and study details for ClariSIGMAM, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The main acceptance criterion derived from the provided text is the agreement between ClariSIGMAM's binary breast density classification and a consensus of expert readers.

2. Sample Size and Data Provenance

• Test Set Sample Size: n=837 (based on the confusion matrix)
• Data Provenance: The document states the dataset "spanned all compatible FFDM systems." It does not explicitly mention the country of origin or if the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Four expert readers.
• Qualifications of Experts: They are referred to as "expert readers" with their assessment being "consensus visual assessment... according to BI-RADS 5th Edition." While specific years of experience or board certifications are not provided, the term "expert radiologist" is used elsewhere in the document when discussing an expert generating breast density measurements using Cumulus software for comparison. For the primary binary breast density task ground truth, they are simply "expert readers."

4. Adjudication Method for the Test Set

• Adjudication Method: "A consensus visual assessment of expert readers" was used to establish the ground truth for BI-RADS breast density category. This implies that the four experts arrived at a shared agreement for each case in the test set. The exact mechanism (e.g., majority vote, discussion to resolve discrepancies) is not detailed, but it was a "consensus" by "independent assessments" initially.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance was not explicitly described. The study primarily focused on the standalone performance of ClariSIGMAM against expert consensus, particularly for the binary density classification.
• Effect Size (if applicable): Not applicable, as this type of study was not reported.

6. Standalone Performance (Algorithm Only)

• Was standalone performance done? Yes. The provided confusion matrix directly illustrates the standalone performance of the ClariSIGMAM algorithm in classifying breast density as "Fatty" or "Dense" when compared to the established ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: The primary ground truth for the binary breast density classification was expert consensus visual assessment according to BI-RADS 5th Edition.
• Other ground truth methods, used for other validations (not necessarily the main acceptance criteria met by the confusion matrix), included:
  • Interactive thresholding software (Cumulus) by an expert radiologist for "Gold Standard breast density estimates."
  • Paired mammograms one year apart to assess reproducibility over time.

8. Sample Size for the Training Set

• The document does not specify the sample size used for the training set. It only discusses the "substantial data sets" used for various validation tests and the "reference standard dataset" for the expert consensus comparison.

9. How Ground Truth for Training Set Was Established

• The document does not explicitly state how the ground truth was established for the training set. It focuses on the validation of the device.

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