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    K Number
    K012386
    Device Name
    ACTICLOT PROTEIN S, MODEL 843L
    Manufacturer
    AMERICAN DIAGNOSTICA, INC.
    Date Cleared
    2001-09-14

    (49 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K955738
    Why did this record match?
    Device Name :

    ACTICLOT PROTEIN S, MODEL 843L

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

    The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.

    Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.

    Device Description

    ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the ACTICLOT® Protein S Quantitative Factor Deficiency Test, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The document describes performance in relation to a predicate device and precision. While explicit, pre-defined acceptance criteria (e.g., "R-value must be greater than X") are not directly stated in the summary, the performance data implicitly serves as the basis for demonstrating substantial equivalence.

    Performance MetricAcceptance Criteria (Implicit from Predicate Equivalence)Reported Device Performance (ACTICLOT Protein S)
    Method Comparison
    Linear Regression (Lot 1)Positive correlation with predicate deviceY = 0.91X + 17.2, R = 0.868
    Linear Regression (Lot 2)Positive correlation with predicate deviceY = 1.06X - 7.5, R = 0.916
    Precision
    Intra-Assay CV% (Normal Control)Low variability (implicitly acceptable)3.0%
    Inter-Assay CV% (Normal Control)Low variability (implicitly acceptable)5.9%
    Intra-Assay CV% (Abnormal Control)Low variability (implicitly acceptable)2.3%
    Inter-Assay CV% (Abnormal Control)Low variability (implicitly acceptable)5.1%

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Method Comparison:
        • Lot 1: n = 78 samples
        • Lot 2: n = 37 samples
      • Precision: n = 80 per control sample (4 replicates over 20 runs for each of the two control levels)
      • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the samples are "human plasma."

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative determination of protein S activity. The performance is assessed against a predicate device and through precision measurements, not against expert human interpretation.

    3. Adjudication method for the test set: Not applicable. See point 2.

    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 is not an AI-assisted diagnostic imaging or interpretation device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The studies described are for the device (ACTICLOT Protein S) performing as an assay. This is inherently a "standalone" performance evaluation in the context of an in vitro diagnostic test, as it quantitatively determines protein S activity directly.

    6. The type of ground truth used:

      • For the method comparison, the "ground truth" is the results obtained from the predicate device (BIOCLOT Protein S-300 ACT). The ACTICLOT device's performance is compared to this established method to demonstrate substantial equivalence.
      • For precision studies, the ground truth is implicitly the known concentration of the control samples.

    7. The sample size for the training set: Not applicable. As an in vitro diagnostic assay, this device does not rely on a "training set" in the machine learning sense. Its performance is based on its chemical and biological principles and optimization of the assay reagents and protocol.

    8. How the ground truth for the training set was established: Not applicable. See point 7.

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