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Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images.

The Imbio CAC Software is a set of medical image post-processing computer algorithms that together performs automated coronary artery calcification segmentation and reports a total Agatston score, calcified lesion mass and volume, and arterial age from thoracic computed tomography (CT) images. The Agatston score, calcified lesion mass and volume are reported both as a total and for each of the following individual coronary arteries: right coronary artery (RCA), left anterior descending (LAD), left circumflex (LCx). The Imbio CAC Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal.

Imbio CAC Software is a Software and Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation. Imbio CAC Software is an aid only used to support a physician in the analysis of CT images.

The Imbio CAC Software program reads in thoracic CT DICOM datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio CAC Software outputs DICOMs of the original input DICOM CT images overlaid with color-codings representing the coronary artery calcification segmentations. Additionally, a summary PDF report is output.

Imbio CAC Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data previously generated by such equipment and is integrated as part of the radiological workflow, reducing the risk of use errors.

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states one acceptance criterion related to quantitative performance.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 500 anonymized chest CT series.
• Data Provenance: Retrospective and multi-center. The images were curated from "a variety of sources including large publically available databases and private imaging data brokers."
  • Patient Demographics:
    • Mean age: 64.3 years (SD: 10 years).
    • Age range: 29 years old to 90+.
    • Gender: 41.7% male, 42.5% female, 15.6% no gender information.
  • Scanner Manufacturers: GE Medical Systems (65.1%), Siemens (19.4%), Imatron (15.2%), and Philips (0.2%).
  • Acquisition Type: Equal split of ECG-gated and non-gated acquisitions.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not explicitly stated as "experts." Instead, "experienced 3D Image Post-Processing Technologists" were used. The number of technologists is not provided.
• Qualifications of Experts: "Experienced 3D Image Post-Processing Technologists." No specific years of experience or board certifications are mentioned.

4. Adjudication Method for Test Set

• The ground truth was established using an "FDA-cleared semi-automated CAC scoring software program." This implies a semi-automated process rather than a direct human expert adjudication method like 2+1 or 3+1. The technologists used this software to annotate the scans.

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

• No MRMC comparative effectiveness study was mentioned or conducted. The study described is a standalone device performance assessment against a ground truth, not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The document states, "Non-clinical testing was conducted in the form of a retrospective, multi-center, standalone device performance assessment." The primary endpoint evaluated the Imbio CAC Software's agreement with the established ground truth.

7. Type of Ground Truth Used

• The ground truth was established by "experienced 3D Image Post-Processing Technologists using an FDA-cleared semi-automated CAC scoring software program." This can be categorized as a form of expert-assisted software output or "reference standard based on a previously cleared device." It is not explicitly stated to be pathology or outcomes data.

8. Sample Size for the Training Set

• The document does not provide information on the sample size for the training set. It only describes the test set used for performance validation.

9. How Ground Truth for Training Set Was Established

• The document does not provide information on how the ground truth for the training set was established. It only describes the ground truth establishment for the test set. Given that the device uses machine learning, a training set with established ground truth would have been necessary for its development, but details are not included in this summary.

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