(106 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).