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510(k) Data Aggregation

    K Number
    K020483
    Device Name
    ADVANTAGE WORKSTATION 4.1
    Manufacturer
    GE MEDICAL SYSTEMS
    Date Cleared
    2002-02-28

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K913770,K942120,K960613
    Why did this record match?
    Device Name :

    ADVANTAGE WORKSTATION 4.1

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

    The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

    Device Description

    Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.

    The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.

    AI/ML Overview

    The provided text is a 510(k) summary for the GE Advantage Workstation 4.1. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove their fulfillment is not explicitly present in this document.

    Here's an analysis based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The document states that the Advantage Workstation 4.1 "provides images comparable to the predicate device." However, it does not provide a table of quantitative acceptance criteria or reported performance metrics against those criteria. The primary "acceptance" criteria for this 510(k) appears to be substantial equivalence to the predicate device, K960613 (Advantage Windows Review Workstation).

    Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Explicit)Reported Device PerformanceComments
    Substantial Equivalence to Predicate Device (Advantage Windows Review Workstation, K960613)Achieved (as determined by FDA's 510(k) clearance)The FDA's letter (K020483) states that the device is "substantially equivalent...to legally marketed predicate devices." This is the core "acceptance" for this regulatory filing.
    Provision of "images comparable to the predicate device."Stated in Section 7: "Advantage Workstation 4.1 provides images comparable to the predicate device."No quantitative comparison or study details are provided to support this claim within the document.
    Integration into Radiology Department WorkflowStated in Section 7: "Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow."This is a qualitative claim. No specific metrics or studies are provided.
    Hazard analysis/Risk Management SummaryCompleted (mentioned in Section 7)No details of the summary or specific risk acceptance criteria are provided.
    Software development and validation processCompleted (mentioned in Section 7)No details of the process or validation results are provided.
    Software verification planCompleted (mentioned in Section 7)No details of the plan or verification results are provided.

    Study Details

    The document does not describe a specific clinical or technical study designed to prove the device meets quantitative performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.

    1. Sample size used for the test set and the data provenance: Not applicable. The document does not describe a test set or study involving patient data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
    3. Adjudication method for the test set: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document predates widespread AI in medical imaging interpretation and does not describe such a study. The device is a workstation for image review, not an AI diagnostic tool.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a workstation for human review, not a standalone algorithm.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
    7. The sample size for the training set: Not applicable. The device is not an AI model that requires a training set.
    8. How the ground truth for the training set was established: Not applicable.
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