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The COR Analyzer I is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The COR Analyzer I is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer I has abilities for coronary vessels segmentations, abnormalities display and processing.

COR Analyzer I is a post processing software application which runs on a stand-alone Windows based work-station. The device input is Computed Tomography Angiography (CTA) set of images. The received data is displayed on the workstation screen, reviewed and selected by the operator for processing. The application enables interactive user-software process in which the user chooses a CT slice, points on the selected coronary vessel and the software present the entire selected vessel as a stretched image. In a reversed process, the user can mark a specific point on the stretched vessel and the software retrieves and displays the original correspondent CT slice. COR Analyzer I output results can be stored for future analysis.

The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria. The 510(k) summary states generally that "Bench and clinical data demonstrate that the COR Analyzer I meets the required specifications," but it does not specify what those specifications are, nor does it provide details about the clinical data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed information about a study based on the provided text.

Here's an explanation of why the requested information cannot be generated from the given text:

• Acceptance Criteria Table and Performance: The document states, "Bench and clinical data demonstrate that the COR Analyzer I meets the required specifications." However, it does not define what those "required specifications" are (e.g., sensitivity, specificity, accuracy thresholds for specific tasks like lesion detection or vessel segmentation). Without these explicit criteria, a table cannot be created.
• Sample Size and Data Provenance: No information is provided regarding the number of cases or studies used, whether the data was retrospective or prospective, or the country of origin.
• Number of Experts and Qualifications: There is no mention of experts, how many were used, or their qualifications (e.g., radiologists, cardiologists, experience level).
• Adjudication Method: No adjudication method (e.g., 2+1, 3+1) is described.
• MRMC Comparative Effectiveness Study: The document does not describe any multi-reader multi-case study comparing human readers with AI assistance versus without. Therefore, an effect size cannot be determined or reported.
• Standalone Performance: While the device is a "post processing software application," the text doesn't explicitly state results from a standalone performance study. It mentions the application enables "interactive user-software process," suggesting a human-in-the-loop design without presenting separate standalone algorithm performance statistics.
• Type of Ground Truth: The document does not specify how ground truth was established for any claimed "clinical data." Options like expert consensus, pathology, or outcomes data are not mentioned.
• Training Set Sample Size and Ground Truth: There is no information provided about a training set, its size, or how its ground truth was established. The document focuses on regulatory submission and device description rather than a detailed study report.

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