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510(k) Data Aggregation

    K Number
    K233790
    Device Name
    ACL TOP 970 CL
    Date Cleared
    2023-12-29

    (31 days)

    Product Code
    Regulation Number
    864.5425
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K231031, K221359, K172903, K034007, K070005, K213464

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

    The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

    The system provides results for both direct measurements and calculated parameters.

    Device Description

    The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series previously FDA cleared under K231031. This family member consists of two side-by-side test modules:

    • . Main Module (ACL TOP 550 CTS, K150877) the subject of this submission
    • Chemiluminescent (CL) Module previously FDA cleared under K221359 .

    The Main Module to the ACL TOP 970 CL instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate (ACL TOP Family 50 Series):

    • . Coagulometric (Turbidimetric) Measurements
    • . Chromogenic (Absorbance) Measurements
    • . Immunological Measurements

    The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series (K231031) and utilizes the same consumables, reagents, calibrators, and controls, and provides the same analytical methodology for routine and specialty assay result reporting as the predicate (ACL TOP Family 50 Series).

    The ACL TOP 970 CL also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "ACL TOP 970 CL" device. This device is a Multipurpose System For In Vitro Coagulation Studies. Based on the content, it does not appear to be an AI/ML-driven device that would involve the complex ground truthing, expert reads, MRMC studies, or training/test set definitions typically associated with such technologies.

    Instead, this submission is for a new hardware configuration (the ACL TOP 970 CL Main Module) that is substantially equivalent to a previously cleared device (ACL TOP Family 50 Series, K150877). The "studies" mentioned are analytical studies (precision and method comparison) to demonstrate that the new configuration performs equivalently to the predicate device for various coagulation assays.

    Therefore, many of the requested points related to AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission and are not found in the provided text.

    Here's an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in a quantified, pre-defined table format for each test. Instead, it refers to industry-standard guidelines (CLSI EP05-A3, CLSI EP09c, 3rd Ed) and states that "all analytical studies were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met and results equivalent to the predicate device."

    However, we can infer the performance metrics from the results presented:

    Performance MetricAcceptance Criteria (Inferred - based on "results equivalent to the predicate device" and meeting CLSI guidelines)Reported Device Performance (ACL TOP 970 CL Main Module)
    PrecisionMeeting CLSI EP05-A3 guidelines for within-run and total %CV and comparability to predicate device performance.(See "Precision" tables below for specific values per assay and material. All deemed acceptable.)
    Method ComparisonDemonstrated equivalence (slope near 1, intercept near 0, high correlation 'r') when compared to predicate device (ACL TOP 550 CTS) across the analytical measuring range. Meeting CLSI EP09c, 3rd Ed guidelines.(See "Method Comparison" tables below for specific values per assay. All deemed acceptable.)
    Thermal VerificationNo impact on analytical results from structural changes.Confirmed no impact.
    Optical Stray Light VerificationNo impact on analytical results from new back wall design.Confirmed no impact.
    Environmental VerificationNo impact on analytical results from changes to skin/air intake.Confirmed no impact.

    Reported Device Performance Tables (from the document):

    HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU - Precision

    MaterialMeanWithin Run %CVTotal %CV
    Low Control7334.34.5
    High Control26642.52.8
    Cut-off Plasma Pool5325.26.0
    High Plasma Pool24352.42.4

    HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity - Precision

    MaterialMeanWithin Run %CVTotal %CV
    Normal Control93.33.74.6
    Abnormal Control26.53.76.5
    Plasma Pool 141.56.37.3
    Plasma Pool 25.84.45.4

    HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds - Precision

    MaterialMeanWithin Run %CVTotal %CV
    Normal Control11.50.51.2
    Abnormal Pool26.30.82.3
    Low Abn Control22.91.62.1
    High Abn Control38.71.12.6

    HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL - Precision

    MaterialMeanWithin Run %CVTotal %CV
    Normal Control3870.91.4
    Low Fibrinogen Control1786.16.3
    Normal Pool3921.32.0
    Abnormal Pool1091.82.4

    HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL - Precision

    MaterialMeanWithin Run %CVTotal %CV
    UF Low Control0.351.822.81
    UF High Control0.651.432.36
    UF Pool0.551.692.27
    LMW High Control1.571.182.15
    LMW Low Control0.642.552.81
    LMW Pool0.711.492.05

    Method Comparison Results (ACL TOP 970 CL vs. ACL TOP 550 CTS):

    HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
    N: 136, Slope: 0.939, Intercept: 27.0, r: 0.996

    HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
    N: 105, Slope: 1.045, Intercept: 0.0, r: 0.993

    HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds
    N: 118, Slope: 1.000, Intercept: 0.25, r: 0.998

    HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL
    N: 123, Slope: 0.991, Intercept: 5.1, r: 0.998

    HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL
    N: 139, Slope: 0.989, Intercept: 0.015, r: 0.997

    2. Sample size used for the test set and the data provenance

    • Precision Test Set Sample Size: For precision studies, samples for each material were run for 20 days, two runs per day, 2 replicates per run (n=80). This applies to each of the multiple materials tested for each assay (e.g., Low Control, High Control, etc.).

    • Method Comparison Test Set Sample Size:

      • HemosIL D-Dimer HS 500: N=136 clinical samples
      • HemosIL Factor VIII deficient plasma: N=105 clinical samples
      • HemosIL RecombiPlasTin 2G (Prothrombin Time): N=118 clinical samples
      • HemosIL RecombiPlasTin 2G (Fibrinogen): N=123 clinical samples
      • HemosIL Liquid Anti-Xa: N=139 clinical samples
    • Data Provenance: The document does not specify the country of origin for the data or explicitly state whether the samples were retrospective or prospective. It mentions "clinical samples" for method comparison and "material" (controls/plasma pools) for precision. Typically, such studies for IVD devices are conducted in a controlled laboratory setting (prospective testing) using a mix of manufactured controls/calibrators and patient samples.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    N/A. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for this in-vitro diagnostic device is the actual measurement of analytes, established by reference methods or validated predicate devices. Proficiency of technical staff operating the instruments would be presumed as per standard laboratory practices.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    N/A. Not applicable to a measurement device; no human interpretation or adjudication beyond standard laboratory quality control and data review.

    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

    N/A. This is not an AI/ML device that assists human readers.

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

    N/A. This is a standalone instrument for in-vitro diagnostic testing, not an algorithm. Its performance is based on its ability to accurately and precisely measure analytes. The "performance" tables provided are essentially the standalone performance of the device.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

    The ground truth for an in-vitro diagnostic coagulation system like this is based on:

    • Reference Materials: For precision, known concentration control materials and plasma pools with established values are used.
    • Comparative Measurements: For method comparison, results from the subject device are compared against a legally marketed predicate device (ACL TOP 550 CTS) which serves as the established reference. The assumption is that the predicate device's measurements are equivalent to the "ground truth" for the test.

    8. The sample size for the training set

    N/A. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a hardware instrument with validated analytical capabilities.

    9. How the ground truth for the training set was established

    N/A. See point 8.

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