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Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses.

The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.

Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications.

Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Autoplaque 3.0. a stand-alone software, performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms.

Autoplaque 3.0 aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling. Autoplaque 3.0 does not replace standard clinical practice or clinician decision making.

Autoplaque 3.0 allows for standardized characterization of plaque and stenosis from DICOM image data (loaded from the local computer hard drive) and includes the following features:

• Review of heart and coronary vessels in Multiplanar Reformatting (MPR), curved MPR, and straightened MPR views:
• Measurement of vessel diameter and area;
• Characterization and measurement of plaque parameters; and
• Measurement of lumen diameter, area, and luminal stenosis.

Autoplaque 3.0 includes automated vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician.

Autoplaque 3.0 can run on Windows or Mac computer platforms. The minimum hardware specifications are specified in the user manual.

Here's an analysis of the acceptance criteria and the studies conducted for Autoplaque 3.0, based on the provided text:

Acceptance Criteria and Device Performance for Autoplaque 3.0

The acceptance criteria for Autoplaque 3.0 focused on establishing concordance and agreement for various plaque and stenosis measurements compared to expert reader measurements and the predicate device. The primary statistical measures used were the intraclass correlation coefficient (ICC) and correlation coefficient. While specific numerical thresholds for "excellent agreement" or "excellent correlation" are not explicitly stated as acceptance criteria, the studies report achieving this level of agreement.

1. Table of Acceptance Criteria and Reported Device Performance

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