Search Results

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The segmented arteries include combined LM+LAD, RCA, and LCX. To obtain separate LM and LAD results, the user must perform manual segmentation. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes. The 3D Calcium View output is provided strictly as an informational and supplementary output and should never be used alone as the method of reviewing the calcium segmentation.

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The application runs on the Vitrea platform.

The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (combined LM+LAD, RCA, LCX) based on the volume and density of the calcium deposits and highlights the Segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases.

The software uses deep learning-based segmentation methods. Users can edit the automated segmentation, including manually assigning calcifications to anatomical structures.

The device automatically outputs a combined LM+LAD score as the final automated output. To obtain separate LM and LAD results, the user must perform manual segmentation using the provided editing tools.

The device is Software as a Medical Device (SaMD) that operates on ECG-gated, non-contrast cardiac CT DICOM images.

The device does not interact directly with the patient. The device is a software application that runs on the Vitrea platform and processes ECG-gated non-contrast cardiac CT DICOM images. The device automatically generates Agatston and volume calcium scores for each of the coronary arteries (LAD+LM, RCA, LCX) based on the volume and density of the calcium deposits and highlights the segmented calcium on the original CT image. Results can be exported to image management, archival, or reporting systems that support DICOM standards for further review and interpretation.

Results can also be saved in DICOM Structured Reports (DICOM SR) format.

The CT VScore+ device is a software application for non-invasive evaluation of calcified lesions of the coronary arteries from ECG-gated, non-contrast cardiac CT images. The study presented demonstrates the analytical validity and performance of the device against predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 236 independent cases.
• Data Provenance: The pivotal validation dataset was sourced from diverse U.S. sites and scanner vendors. The development dataset, from which the test set was independent, included data from four institutions (two US sites and two Japanese sites). The 236 cases for validation were "independent" at both the patient level and the site level from the development dataset. It is retrospective data.

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

• Number of Experts: Three.
• Qualifications of Experts: U.S. board-certified radiologists/cardiologists. (Specific years of experience are not mentioned).

4. Adjudication Method for the Test Set

• Adjudication Method: A "2+1 consensus process" was used. This typically means that if two experts agree, their consensus defines the ground truth. If there's a disagreement between two, the third expert acts as a tie-breaker or adjudicator.

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

• The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the AI algorithm against a consensus ground truth.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was conducted. The metrics listed in the table (ICC, Kappa, Dice Score) directly assess the performance of the CT VScore+ algorithm in isolation against the established ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, the reference standard ground truth was established by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240) and a 2+1 consensus process by three U.S. board-certified radiologists/cardiologists.

8. Sample Size for the Training Set

• Sample Size (Training Set): 94 cases (part of the 210 cases used for development).

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

• The document implies that the ground truth for the training set (part of the development dataset) was established similarly to the validation set's ground truth, i.e., "by consensus manual scoring on an FDA-cleared device (Vitrea CT VScore, K243240)" by experts, given that the development process involved ensuring "robust and unbiased performance." However, the exact details of ground truth establishment specifically for the training set are not explicitly broken out as they are for the pivotal validation dataset. It's reasonable to infer a similar rigorous process if the data was used for deep learning model development.

Ask a specific question about this device