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510(k) Data Aggregation

    K Number
    K190993
    Device Name
    Kinepict Medical Imaging Tool version v2.2
    Manufacturer
    Kinepict Health Ltd
    Date Cleared
    2020-03-05

    (324 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K153346
    Why did this record match?
    Reference Devices :

    K153346

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

    Kinepict Medical Imaging Tool version v2.2 is intended to visualize blood vessel structures by detecting the movement of the contrast medium bolus in standard-of-care angiography examination. This software is intended to be used in addition to, or as replacement for current DSA imaging.

    Kinepict Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, Kinepict Software can be deployed on systems of several angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

    Kinepict Software can also be combined with fluoroscopy systems or Radiographic systems.

    Device Description

    The Kinepict Medical Imaging Tool is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with Syngo Application Software VD11 (Siemens Medical Solutions USA Inc. under K153346) or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

    Kinepict Medical Imaging Tool is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, platform

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Kinepict Medical Imaging Tool version v2.2, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list. However, based on the Summary and Conclusions and Primary effectiveness endpoints and results sections, the implicit acceptance criteria appear to be:

    Acceptance Criteria (Inferred from Study Goals)Reported Device Performance (Kinepict DVA)
    Signal-to-Noise Ratio (SNR) Improvement over DSAClinical Study: Overall median SNR of DVA images was 2.3-fold higher than that of DSA images (based on 1902 ROIs in 110 image pairs).
    Non-Clinical Data: Kinetic images provided 3.3 times (median) and 2.3 times (median) better SNR than raw and post-processed DSA images, respectively (based on 45 XA series).
    Non-clinical test concluded DVA provides "better" SNR than DSA.
    Visual Image Quality Improvement/Equivalency to DSA (Expert Consensus)Clinical Study: Raters judged the DVA images better in 69% of all comparisons (out of 238 pairs).
    Summary and Conclusions: Six specialists found an LA (level of agreement) of > 73% (p > 0.0001) that kinetic imaging provided higher quality images than DSA.
    Inter-rater Agreement for Visual QualityClinical Study: Interrater agreement was 81% and Fleiss κ was 0.17 (P
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