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    K Number
    K011741
    Device Name
    CRIT-LINE MONITOR III TQA (CLM TQA)
    Manufacturer
    HEMAMETRICS
    Date Cleared
    2002-07-23

    (413 days)

    Product Code
    FIL
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMAMETRICS

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

    The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.

    Device Description

    The CRIT-LINE III TQA is an FDA cleared device that non-invasively measures Hct, O2 Sat, Percent Change in Blood Volume. The CLM III TOA also estimates Access Recirculation and Access Blood Flow. The URR sensor is an additional attachment to the CRIT-LINE III TOA. The optical light emitted by the URR sensor is directed through the spent dialysate stream and absorbed by the constituents of the spent dialysate. The transmitted light is then detected and the relative urea nitrogen concentration in the spent dialysate is calculated.

    AI/ML Overview

    The CRIT-LINE III TQA Monitor is intended to non-invasively calculate the Urea Reduction Ratio (URR) based on changes in urea nitrogen concentration in spent dialysate. The device was compared to the EktaChem DT 60 (Vitros DT60 Chemistry System), a legally marketed predicate device.

    Here's an analysis of the acceptance criteria and study information:

    1. Acceptance Criteria and Reported Device Performance

    The submission does not explicitly state pre-defined acceptance criteria in terms of specific statistical thresholds for R-squared or standard error for the overall URR calculation. Instead, it presents the results of the comparative studies with the predicate device as evidence of substantial equivalence.

    Performance MetricAcceptance Criteria (Implied by Predicate Performance)Reported Device Performance (CLM III TQA URR Sensor)
    In-vivo Relative Urea Nitrogen Concentration (mg/dL)Not explicitly stated but compared to EktaChem DT 60 as predicateStandard error of 5.8 mg/dL and R² of 0.84
    In-vitro Urea Nitrogen Concentration (mg/dL)Not explicitly stated but compared to EktaChem DT 60 as predicateStandard error of 1.2 mg/dL and R² of 0.998 (range 0-83 mg/dL)

    2. Sample Size and Data Provenance

    Test Set:

    • Sample Size:
      • In-vivo study: 51 data points for URR calculation. This was gathered from 36 patients.
      • In-vitro study: Not explicitly stated as a number of samples, but "measurements at each urea nitrogen concentration" were performed across a range of 0-83 mg/dL.
    • Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The date range of data collection (January 1 to May 10, 2001) is provided, indicating it was prospective data collection for the in-vivo study.

    3. Number of Experts and Qualifications for Ground Truth

    In-vivo study: Not applicable. The ground truth for the in-vivo study was established by the EktaChem DT 60, a laboratory analyzer.
    In-vitro study: Not applicable. The ground truth for the in-vitro study was established by the Kodak EktaChem DT 60 analyzer using known concentrations of pure urea.

    4. Adjudication Method for the Test Set

    Not applicable. The ground truth was established by laboratory analysis (EktaChem DT 60) for both in-vivo and in-vitro studies, not by human expert adjudication.

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

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on comparing the device's measurements to a predicate laboratory device.

    6. Standalone Performance (Algorithm Only)

    Yes, a standalone performance assessment was done. The study directly compared the CRIT-LINE III TQA URR sensor's measurements against the EktaChem DT 60 without human intervention for the URR calculation claim.

    • In-vivo: The CLM III TQA's calculated URR based on relative urea nitrogen concentration in spent dialysate was compared to URR measurements calculated by the EktaChem DT 60 (based on urea nitrogen concentration measurements in both blood and spent dialysate).
    • In-vitro: The URR sensor measurements were compared against reference urea nitrogen concentrations measured by the Kodak EktaChem DT 60 analyzer using calibrated solutions.

    7. Type of Ground Truth Used

    The ground truth used was predicate device measurements / laboratory analysis:

    • In-vivo: The EktaChem DT 60's calculation of URR, which itself is based on urea nitrogen concentration measurements in both blood and spent dialysate.
    • In-vitro: Reference urea nitrogen concentrations measured by a Kodak EktaChem DT 60 analyzer with pure urea dissolved in fresh dialysate.

    8. Sample Size for the Training Set

    The document does not explicitly mention a separate "training set" or its sample size. The description focuses on the studies conducted to demonstrate substantial equivalence, which would be considered the validation data.

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

    Not applicable, as no separate training set is described. The predicate device's measurements served as the reference for the validation studies.

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