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510(k) Data Aggregation

    K Number
    K182225
    Device Name
    Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2019-03-04

    (200 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K162895
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dimension Vista® High-Sensitivity Troponin I (TNIH) assay is for in vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma using the Dimension Vista system. The assay can be used to aid in the diagnosis of acute myocardial infarction (AMI).

    Device Description

    The Dimension Vista® TNIH assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI reagents include two synthetic bead reagents and two biotinylated anti-cardiac troponin I monoclonal antibody fragments. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitizer dye. The second bead reagent (Chemibeads) is coated with a third anticardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibodies to form bead-cardiac troponin Ibiotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample. Lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 – 8 °C, is stable sealed on system for 30 days and opened on the system for 7 days. Calibration is performed every 30 days for a reagent lot.

    AI/ML Overview

    The provided document describes the Siemens Healthcare Diagnostics Dimension Vista High-Sensitivity Troponin I (TNIH) Assay. The following information regarding its acceptance criteria and a study proving its performance is extracted:

    Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance CriteriaReported Device Performance
    Detection Limit
    - Limit of Blank (LoB)95th percentile of all values, measured using a non-parametric approach.1.0 pg/mL
    - Limit of Detection (LoD)Non-parametric approach following CLSI EP17-A2.2.0 pg/mL (consistent with range of 0.7 - 1.9 pg/mL)
    Limit of Quantitation (LoQ)Analyte level with a within-lab CV of ≤ 20.0%.3.0 pg/mL (Lot-1: 1.2 pg/mL, Lot-2: 2.4 pg/mL, Lot-3: 2.2 pg/mL)
    10% CV LimitAnalyte level with a within-lab CV of ≤ 10.0%.Consistent with 10.0 pg/mL (Lot-1: 2.7 pg/mL, Lot-2: 5.7 pg/mL, Lot-3: 5.4 pg/mL)
    PrecisionAll precision goals were met. (Specific goals for SD and %CV not explicitly detailed but implied by "All precision goals were met" statement).Repeatability: Plasma 1 (48.9 pg/mL): 1.12 SD, 2.3% CV; Plasma 2 (157.7 pg/mL): 1.55 SD, 1.0% CV; QC (8088.5 pg/mL): 99.54 SD, 1.2% CV.Within-Lab: Plasma 1: 3.05 SD, 6.2% CV; Plasma 2: 2.60 SD, 1.6% CV; QC: 200.36 SD, 2.5% CV.
    LinearityThe p values of nonlinear terms in the quadratic and cubic fit equations are non-significant (p ≤ 0.05). If p-value > 0.05, then allowable bias is ≤ 10% or 3 pg/mL, whichever is greater.Confirmed linearity from 3.0 - 25,000.0 pg/mL.
    InterferencesBias exceeding 10% is considered interference.Exogenous Compounds: No interference detected from Hemoglobin (400 mg/dL), Bilirubin (conjugated 30 mg/dL, unconjugated 40 mg/dL), Lipemia (3000 mg/dL) at approximately 40 pg/mL and 1350 pg/mL cTnI. Numerous therapeutic/toxic substances: No interference detected at specified low/therapeutic and high/toxic concentrations (details in document for each substance).
    High Dose Hook EffectNot explicitly stated as a numerical criterion, but implies absence of hook effect.No hook effect found at 1,000,000 pg/mL troponin.
    Dilution RecoverySupported use of diluent for over-range samples. (Specific numerical criteria not explicitly stated).Testing supported use of the diluent for over-range samples.
    Calibration StabilityP-value of regression slope ≥ 0.05 OR drift ≤ LoQ OR drift ≤ 10% for values up to 20,000 pg/mL OR drift ≤ 13% for values > 20,000 pg/mL.Calibration interval measured to be 30 days.
    Open Well StabilityP-value of regression slope ≥ 0.05 OR drift ≤ LoQ OR drift ≤ 10% for values up to 20,000 pg/mL OR drift ≤ 13% for values > 20,000 pg/mL.Stability of reagents opened onboard the instrument was 7 days per well set.
    Sample StabilityLower bound of the one-sided 95% confidence interval of the regression line must be ≤ -10% AND all individual data points must have a bias of ≤ -20% when compared to time zero.Separated samples stable for 8 hours at room temperature, 24 hours at 2-8 °C, up to 40 days at or below -20 °C (non-frost free), and up to 1 year at or below -70 °C.
    Clinical Performance (Sensitivity)Not explicitly stated as acceptance criteria, but clinical performance is assessed for diagnostic accuracy.Pooled Gender (58.9 pg/mL 99th percentile): ranged from 79.0% (0-<1.5h) to 94.2% (4.5-<6h).Female (53.7 pg/mL 99th percentile): ranged from 83.3% (0-<1.5h) to 96.4% (>24h).Male (78.5 pg/mL 99th percentile): ranged from 74.0% (0-<1.5h) to 90.3% (9-24h).
    Clinical Performance (Specificity)Not explicitly stated as acceptance criteria.Pooled Gender: ranged from 85.5% (>24h) to 92.5% (0-<1.5h).Female: ranged from 83.8% (>24h) to 94.4% (0-<1.5h).Male: ranged from 87.2% (9-24h) to 92.5% (0-<1.5h).
    Clinical Performance (NPV)Not explicitly stated as acceptance criteria.Pooled Gender: ranged from 96.9% (0-<1.5h) to 99.0% (3.5-<4.5h and 4.5-<6h).Female: ranged from 98.2% (0-<1.5h) to 99.5% (4.5-<6h).Male: ranged from 95.4% (0-<1.5h) to 97.7% (3.5-<4.5h).

    Study Information

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

      • 99th Percentile Determination: 2021 apparently healthy individuals from the United States (1017 female, 1004 male) for lithium heparin plasma. Provenance is prospective from the United States.
      • Clinical Performance Study: Approximately 2500 subjects in lithium heparin plasma. Specimens collected at 29 emergency departments across the United States. Provenance is prospective.

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

      • 99th Percentile Determination: No explicit mention of experts establishing ground truth for healthy individuals; values were statistically determined.
      • Clinical Performance Study: Panels of certified cardiologists and emergency physicians. The exact number of experts per panel is not specified, but panels are plural.

    3. Adjudication method for the test set:

      • For the clinical performance study, subject diagnoses were adjudicated by panels of certified cardiologists and emergency physicians according to the Third Universal Definition Of Myocardial Infarction - a consensus guideline endorsed by the European Society of Cardiology (ESC), the American College of Cardiology Foundation (ACCF), the American Heart Association (AHA), and the World Heart Federation (WHF). This indicates a consensus-based adjudication process guided by established clinical criteria. The exact number of clinicians per panel or specific rules (e.g., 2+1) are not provided, but the use of "panels" implies multiple reviewers.

    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:

      • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study describes the performance of an in vitro diagnostic assay for measuring cardiac troponin I, not an AI or human-assisted diagnostic device.

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

      • Yes, this is a standalone study. The device is an in vitro diagnostic assay (a test kit for laboratory use) and its performance is evaluated directly. There is no AI or software algorithm being assessed for human-in-the-loop performance. Its output (troponin I concentration) is then used by clinicians for diagnosis.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • 99th Percentile Determination: Ground truth for healthy reference ranges was established by statistical analysis (non-parametric method) of values from apparently healthy individuals.
      • Clinical Performance Study: Ground truth for Acute Myocardial Infarction (AMI) diagnosis was established by expert consensus based on the Third Universal Definition Of Myocardial Infarction by panels of certified cardiologists and emergency physicians. This combines clinical presentation, ECG changes, and biomarker elevation (including troponin, but adjudicated independently from the device under test).

    7. The sample size for the training set:

      • No training set is mentioned in the context of machine learning or AI, as this is an in vitro diagnostic assay that reports quantitative measurements. The "training" in this context refers to the development and optimization of the assay's chemical reagents and detection method.

    8. How the ground truth for the training set was established:

      • Not applicable, as this is not a machine learning model with a distinct training set and corresponding ground truth. The assay's performance characteristics (e.g., LoB, LoD, LoQ, linearity, precision, interference) are established through analytical studies using reference materials, spiked samples, and native clinical samples, as detailed in the "Summary of Performance Testing" section.
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