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510(k) Data Aggregation

    K Number
    K243145
    Date Cleared
    2025-04-10

    (192 days)

    Product Code
    Regulation Number
    892.2080
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    syngo.CT LVO Detection

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. It is intended for all patient populations of age ≥ 22 years, without any of the following contraindications: old infarcts or other diseases impacting the brain vasculature (for example, brain tumors), metal artifacts (for example, coils), surgical signs in the images. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image.

    Device Description

    The subject device syngo.CT LVO Detection is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians (Radiologists, Neuroradiologists, Neurologists) in prioritization of CT-angiography images by algorithmically identifying findings suspicious of a large vessel occlusion and providing notification to the user. syngo.CT LVO Detection provides a reproducible detection of large vessel occlusions (LVO) on contrast-enhanced CT examinations of the head for detection of ICA, M1, and M2 vessel occlusions in patients suspected of having stroke related circulation occlusion. syngo.CT LVO Detection analyses CT-angiography (CTA) images of the head. The subject device provides a pipeline for the analysis and identification of potential LVO The output which can be send to an external notification device does not highlight or direct attention of the reading physician to any portion of the image.

    AI/ML Overview

    Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for syngo.CT LVO Detection:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceComments
    Sensitivity > 80%90.6% [86.8% - 93.3%] (95% CI)Exceeds the predefined acceptance threshold.
    Specificity > 80%88.8% [84.7% – 91.9%] (95% CI)Exceeds the predefined acceptance threshold.
    Processing Time
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