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    K Number
    K965103
    Device Name
    WINMAX SOFTWARE SYSTEMS
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1997-05-09

    (140 days)

    Product Code
    JJF,DGC,DHB
    Regulation Number
    862.2170
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DPC's WinMAX software system is a comprehensive software program for processing DPC's in vitro diagnostic assays, the AlaSTAT and AlaTOP immunodiagnostic allergy test kits, in the microtiter plate format . It is intended for in vitro diagnostic use only

    Device Description

    Software program

    AI/ML Overview

    The provided text is for a software system called WinMAX, which processes results from in vitro diagnostic allergy test kits (AlaSTAT and AlaTOP). The information primarily focuses on a method comparison study to demonstrate the equivalence of the WinMAX software to an existing MAX software system.

    Here's an analysis based on your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (WinMAX vs. MAX software)
    Equivalence in quantitative results for serum samples tested for allergensLinear regression: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L
    High correlation between WinMAX and MAX software resultsCorrelation coefficient of 0.960

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: 262 serum samples were initially tested. Of these, 163 samples gave quantitative results within the reportable ranges of both software systems and were used for the linear regression analysis.
    • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

    Not applicable. The study compares the performance of two software systems against each other, not against a human expert's interpretation or a biological ground truth in the traditional sense. The MAX software system acts as the comparator.

    4. Adjudication Method for the Test Set

    Not applicable. This was a direct comparison between two software systems' outputs, not a human consensus or adjudication process.

    5. 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

    No, an MRMC comparative effectiveness study was not done. The study compares two software systems, not human readers with and without AI assistance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, this was a standalone comparison of two software algorithms (WinMAX vs. MAXsoftware) in processing the results of allergy test kits. There is no human-in-the-loop performance described.

    7. The Type of Ground Truth Used

    The "ground truth" in this context is the results generated by the existing MAX software system. The study aims to demonstrate that WinMAX is equivalent to this established system, rather than to an independent, definitive biological or clinical outcome.

    8. The Sample Size for the Training Set

    No information is provided about a training set. This document describes a comparison study, not the development or training of the WinMAX software itself.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as no training set is described.

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