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510(k) Data Aggregation

    K Number
    K111311
    Device Name
    SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
    Manufacturer
    OMISA INC. (SEGASIST TECHNOLOGIES)
    Date Cleared
    2011-10-17

    (160 days)

    Product Code
    MUJ, JAK, KPQ, LHN, LLZ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMISA INC. (SEGASIST TECHNOLOGIES)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Segasist P-AC contouring software is a standalone software application for Windows platforms that assists clinicians in generating estimates of the anatomy boundary contours of the prostate gland in Computed Tomography (CT) scans, Magnetic Resonance (MR) images and ultrasound (sonography) scans to aid in patient diagnosis, treatment planning and post-treatment monitoring. The software is intended to be used to provide clinicians with tools to efficiently contour/delineate the prostate gland in volume data and save the results in DICOM and BMP format. The clinician has the ability to use the saved contours directly or import them in other software tools to perform the task at hand. The clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images. The Segasist P-AC software tool is a compliment to manual contouring techniques.
    Device Description
    Segasist P-AC (Segmentation Assistant for Prostate – Auto-Contouring) is a standalone atlas-based segmentation software tool for auto-contouring of the prostate gland from different input image modalities (Computed Tomography (CT) scans, Magnetic Resonance (MR) images, ultrasound scans). The software can read, write and display DICOM images from/to local directories, and offers the possibility of defining regions of interest (ROls) around the prostate gland in order to delineate the prostate for contouring, visual assessment, and size and volume calculation purposes, either manually, or via semi-automated or automated processes. The Segasist P-AC software is a tool that has been designed and developed to assist clinicians (radiologists, oncologists, medical physicists etc.) in performing contouring/delineation of the prostate gland in images in multiple modalities more efficiently. The software is capable of segmenting the prostate gland in individual slices, in a choice of different modalities, and for any given view (axial, sagittal, or coronal). This is done by requiring some user input (clicks or drawing ROIs). For volume prostate data. Segasist P-AC calculates the prostate volume in cubic centimeters and displays the contours on each slice. The results (contours) can be saved as DICOM or binary images (BMP), which can be edited/modified at any time, completely dismissed or accepted and saved by the end user. The efficiency of contouring performed by the Segasist P-AC software may be improved by generating/using an advanced atlas using gold standard images created by the experienced clinician(s). This requires the software to be trained (atlas creation) before being used. The software can be delivered pre-trained with the comprehensive atlas or the end user can generate their own atlas; a well-established practice for atlas-based segmentation software products. Segasist P-AC also offers a built-in editor, enabling the user to edit, modify, or change the extracted prostate boundaries to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the Segasist P-AC software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. In addition, the end user can delineate the prostate gland manually using the P-AC software, if necessary or desired. As a result, when Segasist P-AC generates a result, the expert user always has the final decision to override the software result, if deemed appropriate in his/her clinical judgment. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the Segasist P-AC result and then save it. The software does not provide any auto-detection or auto-saving functionalities. Regardless of the accuracy of Segasist P-AC result. it is always the experienced clinician that remains the decision maker regarding the acceptability of the computed segmentation. Therefore, the final decision on diagnosis, treatment and overall management of the patient is not based on the software result. Segasist P-AC software does not alter the original input images of the prostate gland. nor does it change the final results obtained once approved by the clinical expert. Segasist P-AC offers several features and functionalities such as, but not limited to: - . Import/Export DICOM images - . Saving Contours to DICOM or BMB format - . Semi-automated Segmentation - . Auto-Segmentation (fast slice-to-slice auto-segmentation with minimal user interactions) - . Volume Segmentation and measurement - . Edge Enhancement (contour enhancement by user controlled edge snapping). - . Standard Functionalities for Image Visualization (windowing, contrast, brightness, zoom, panning etc) - . Advanced Functionalities for Contour Editing For Manual Segmentation (drawing, inflating, deflating, shifting, cut & add etc) - . User access to modify the resulting contours at any time
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