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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.

Prescription use only.

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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