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The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.

This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements. The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose'Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.

The Philips MicroDose SI (model L50) is an add-on functionality to a previously cleared full-field digital mammography (FFDM) system that allows for breast density measurements. The device measures volumetric glandularity, glandular volume, breast volume, and provides a breast density score correlated to BI-RADS categories.

Here's an analysis of its acceptance criteria and the study performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MicroDose SI Breast Density Measurement application were established by evaluating its parameters against industry standard breast tissue equivalent phantoms and a substantial clinical screening population dataset. The exact quantitative acceptance criteria (e.g., specific thresholds for correlation coefficients or agreement percentages) are not explicitly stated in the provided text. However, the study aimed to confirm several aspects:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "a substantial clinical screening population dataset"
• Data Provenance: The document does not explicitly state the country of origin. It mentions "a substantial clinical screening population dataset," implying real-world clinical data. It is a retrospective study based on an existing dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated, but "MQSA qualified radiologists" were involved.
• Qualifications of Experts: "MQSA qualified radiologists." MQSA (Mammography Quality Standards Act) qualification ensures radiologists are trained and certified to interpret mammograms in the United States.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It states "the BI-RADS breast composition score given by MQSA qualified radiologists," implying that the radiologists' scores were used as a reference for comparison, but doesn't detail how discrepancies among multiple radiologists would have been resolved if applicable.

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

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study, which typically evaluates human readers with and without AI assistance, was not explicitly described. The study focused on the correlation between the device's density scores and radiologists' BI-RADS scores, as well as internal consistency and expected biological correlations, rather than the improvement of human reader performance with AI assistance.
• Effect size of human reader improvement: Not applicable, as an MRMC comparitive effectiveness study with human-in-the-loop performance measurement was not described.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was conducted. The MicroDose SI L50 Breast Density Measurement application's ability to measure and output volumetric glandularity, glandular volume, breast volume, and a breast density score is an inherent standalone function. The study evaluated these independent measurements against:

• Industry standard breast tissue equivalent phantoms.
• Correlation with radiologists' BI-RADS scores.
• Internal consistency (across views, laterality).
• Expected biological correlations (with age, breast volume).

7. Type of Ground Truth Used

The ground truth for the clinical correlation aspects of the test set was:

• Expert Consensus: Specifically, "the BI-RADS breast composition score given by MQSA qualified radiologists." This implies expert interpretation of the mammograms.
• Physiological/Biological Correlates: Age and breast volume were used to confirm expected biological relationships with volumetric glandularity.
• Physical Phantoms: Used to validate density measurements against known standards.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "a substantial clinical screening population dataset" for the evaluation (test set), but does not distinguish this from a training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for any potential training set was established. The focus of the provided text is on the validation activities of the developed application.

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