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Elucid PlaquelQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

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Elucid PlaquelQ is an image analysis application for evaluating CT angiography images of arterial vessels. Elucid PlaquelQ provides multi-dimensional visualization to aid clinicians in their analysis of plaque anatomy and pathology (e.g., atherosclerosis). Elucid PlaquelQ supports physician review and interrogation of the Elucid conducted segmentation to inform their clinical interpretation of the Elucid PlaqueIQ Analysis.

The provided text does not contain detailed information about the acceptance criteria and a specific study that proves the device meets those criteria. It focuses on the regulatory submission, device description, and comparison to predicate devices, stating that "Validation testing confirmed that the performance of the software met the pre-defined acceptance criteria" without listing what those criteria are or describing the study in detail.

Therefore, I cannot provide the requested information. The document summarily states that:

• Verification testing confirmed overall functionality and repeatability.
• Validation testing confirmed performance against pre-defined acceptance criteria.
• Usability testing was conducted with intended users.

It concludes that the nonclinical verification and validation test results established that the device meets its design requirements and intended use. However, specifics regarding acceptance criteria, study design, sample sizes, ground truth establishment, or any comparative effectiveness studies are not present.

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vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.

vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.

Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.

The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.

vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

The provided document is a 510(k) premarket notification letter from the FDA to Elucid Bioimaging, Inc. concerning their device, vascuCAP. While it outlines the device's intended use and the general process of software verification and validation, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment methods, or whether MRMC studies were conducted.

The document indicates that software verification and validation were performed consistent with FDA guidance on "General Principles of Software Validation," and that "Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions." However, it does not present the results of this validation in a quantitative manner or specify the details requested in your prompt.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study design and results from the provided text. The document concludes that "vascuCAP is as safe and effective as the predicate device for the intended use" based on this general testing, but the specifics of how that was demonstrated are not included.

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