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    K Number
    K163522
    Device Name
    FilmArray Warrior Control Panel M290
    Manufacturer
    Maine Molecular Quality Controls, Inc.
    Date Cleared
    2017-03-14

    (89 days)

    Product Code
    PMN
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K161573
    Why did this record match?
    Device Name :

    FilmArray Warrior Control Panel M290

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

    FilmArray Warrior Control Panel M290 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bacillus anthracis (Chromosomal element, pXO1, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus on the FilmArray NGDS Warrior Panel performed on FilmArray 2.0 systems. FilmArray Warrior Control Panel M290 is composed of synthetic DNA specifically designed for and intended to be used solely with the FilmArray NGDS Warrior Panel assay. This product is not intended to replace manufacturer internal FilmArray NGDS Warrior Panel controls provided with the device.

    Device Description

    FilmArray Warrior Control Panel M290, P/N M290, is a quality control panel consisting of 2 controls, FilmArray Warrior Positive Control, P/N M291 and FilmArray Warrior Negative Control, P/N M292. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA carries segments of all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Table 1. below) on FilmArray 2.0 systems. The Negative Control is comprised of non-specific DNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray Warrior Control Panel M290 is processed separately according to FilmArray NGDS Warrior Panel assay manufacturer's Instructions for Use for Blood Samples.

    AI/ML Overview

    The document describes the performance study for the FilmArray Warrior Control Panel M290, an assayed quality control material for clinical microbiology assays.

    Here's the breakdown of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document implies an acceptance criterion for "Percent Correct" results of 95% or greater for the external clinical study.

    Acceptance Criteria (Implied)Reported Device Performance (Table 2: All Sites)
    External Site Performance:99.4% Total Correct Results
    Percent Correct Positive Control ≥ 95%98.8%
    Percent Correct Negative Control ≥ 95%100%

    2. Sample Size and Data Provenance

    Test Set (External Study):

    • Total Tests: 310 (163 positive controls, 147 negative controls)
    • Data Provenance: Retrospective and prospective. The study was conducted over 6 months at 5 clinical laboratory sites, incorporating 12 unique pouch lots and multiple operators. The document does not specify countries of origin, but "clinical laboratory sites" typically refers to facilities within the country of the product's intended market (USA, based on FDA review).

    3. Number of Experts and Qualifications for Ground Truth

    Not applicable. This device is a quality control material, not an AI or diagnostic device that requires expert interpretation for establishing ground truth. The "ground truth" for the controls is their known composition (positive for specific pathogens, negative for all pathogens).

    4. Adjudication Method

    Not applicable, as this is a quality control material with known positive and negative components, not a diagnostic device requiring expert adjudication of results.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This study focuses on the performance of a quality control material in monitoring the FilmArray NGDS Warrior Panel assay, not on the effectiveness of human readers, with or without AI assistance.

    6. Standalone Performance Study

    Yes, a standalone performance study was done. The entire study describes the performance of the FilmArray Warrior Control Panel M290 itself, demonstrating its ability to produce expected positive and negative results when run on the FilmArray NGDS Warrior Panel.

    7. Type of Ground Truth Used

    Known Composition: The ground truth is the known synthetic DNA composition of the positive and negative control panels.

    • Positive Control: Contains synthetic DNA segments for all biothreat agents detected by the FilmArray NGDS Warrior Panel assay (Bacillus anthracis: Chromosomal element, pXO1, pXO2, Coxiella burnetii, Francisella tularensis, Yersinia pestis, Ebola virus and Marburg virus).
    • Negative Control: Comprised of non-specific DNA.

    8. Sample Size for the Training Set

    Not applicable. This is a quality control material, not a machine learning model, so there is no "training set" in the traditional sense. The controls are designed with known compositions to test the performance of a diagnostic assay.

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

    Not applicable, as there is no training set. The ground truth for the control material itself is based on its manufactured composition.

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