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510(k) Data Aggregation

    K Number
    K072079
    Device Name
    IGUIDE SYSTEM
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
    Date Cleared
    2007-08-14

    (15 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K072079,k041448,k983678,k033343,K913119,k910971
    Why did this record match?
    Reference Devices :

    K072079, K041448, K983678, K033343, K913119, K910971

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

    The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

    Device Description

    The iGUIDE System is a powered radiation therapy support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (K041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (K983678), Varian Trilogy Radiotherapy Delivery System (K033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (K910971)

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The 510(k) summary explicitly states:

    "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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