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    K Number
    K982412
    Device Name
    MODIFICATION OF CRIT-LINE MONITOR III (CLM III)
    Manufacturer
    IN-LINE DIAGNOSTICS CORP.
    Date Cleared
    1998-10-09

    (88 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K972470,K960817
    Why did this record match?
    Device Name :

    MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

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

    The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.

    Device Description

    The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

    CRIT-LINE MONITOR III (CLM III) with Access Blood Flow (ABF) Feature

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Correlation coefficient value near 1 (i.e., .90 or greater) between CLM III ABF values and Transonic HD01 ABF values"The results from the two tests indicate that the above described criteria were met." (Implies a correlation coefficient of .90 or greater was achieved)

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

    • Sample Size: 44 patients
      • 30 patients from the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah.
      • 14 patients from Victoria Hospital South in London, Ontario, Canada.
    • Data Provenance: Prospective (described as "during normal dialysis sessions" and "during the study, a formal protocol was followed").
    • Country of Origin: USA (Utah) and Canada (Ontario).

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

    The ground truth was not established by human experts in this study. Instead, a predicate device, the Transonic HD01 Monitor, was used as the reference standard for Access Blood Flow (ABF) measurements.

    4. Adjudication Method for the Test Set

    Not applicable, as the ground truth was based on a predicate device's measurements, not expert adjudication.

    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, this was not an MRMC comparative effectiveness study. The study focused on demonstrating substantial equivalence of a new feature (ABF calculation) of an existing device to a legally marketed predicate device. There is no mention of human readers or AI assistance effect sizes.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Yes, this was a standalone performance study. The CLM III, with its built-in capacity to measure hematocrit, was used to calculate ABF values independently. These calculated values were then compared to the ABF values obtained from the predicate Transonic HD01 Monitor. The CLM III itself did not involve human intervention in the ABF calculation process, but rather provided the raw data (hematocrit) from which ABF was calculated using external means (calculator or spreadsheet).

    7. The Type of Ground Truth Used

    The ground truth used was measurement from a legally marketed predicate device, specifically the Transonic HD01 Monitor.

    8. The Sample Size for the Training Set

    The document does not mention a separate training set. The study describes the comparison of the CLM III's ABF values to the Transonic HD01 Monitor's values. The ABF calculation method for the CLM III (from real-time hematocrit measurements) already existed, and the purpose of the submission was to claim ABF as an additional feature without hardware or software changes to the current device. Therefore, it appears the "training" was implicitly done during the initial development of the CLM III's hematocrit measurement capabilities, not specifically for the ABF feature using the data from this submission.

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

    As no specific training set for the ABF feature is described, the ground truth establishment for a training set is not detailed. The CLM III's core functionality (hematocrit measurement) would have been established through prior validation. The ABF calculation itself appears to be a mathematical derivation from these pre-established hematocrit measurements, rather than requiring a dedicated training set with new ground truth data for the ABF parameter itself.

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