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510(k) Data Aggregation

    K Number
    K210811
    Device Name
    Dynamyx Digital Pathology Software
    Manufacturer
    Inspirata, Inc.
    Date Cleared
    2022-03-01

    (349 days)

    Product Code
    QKQ
    Regulation Number
    864.3700
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    K190332
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inspirata, Inc.

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

    Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

    Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

    It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.

    The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.

    Device Description

    Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.

    Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the images to the Dynamyx viewer.

    Note that Dynamyx has two different applications for two different inputs as specified below.

    1. The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.

    2. The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.

    Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images.

    Dynamyx incorporates typical histology/pathology workflow and is operated as follows:

      1. Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx.
      1. Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist.
      1. The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive.
      1. The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image:
      • a. Zoom and pan the image at will;
      • b. Adjust the apparent image observed magnification level;
      • c. Measure distances and areas;
      • d. Annotate images and cases;
      1. The above steps are repeated as required.

    After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.

    AI/ML Overview

    There is no information regarding acceptance criteria and a study proving the device meets it for an AI/ML clinical decision support function in the provided text. The document refers to the Dynamyx Digital Pathology Software, which is a viewing and management software for digital images of pathology slides, not an AI/ML device.

    The document discusses non-clinical performance testing for image reproduction, turnaround time, measurement accuracy, and usability, demonstrating substantial equivalence to predicate devices, but this is for the core functionality of a digital pathology viewer, not an AI feature.

    Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them.

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