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    K Number
    K141161
    Device Name
    ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
    Manufacturer
    HORIBA ABX SAS
    Date Cleared
    2014-12-20

    (229 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    k030799,K030799
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

    Device Description

    The ABX MICROS ES 60 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting, quality control, calibration, and cleaning. The system is a microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. It operates in complete blood count (CBC) and Differential (DIFF) mode using a combination of focused flow impedance and light transmission technologies. It is available in Closed (CT) or Open Tube (OT) sampling versions.

    AI/ML Overview

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

    Acceptance Criteria and Device Performance for ABX Micros ES 60

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides acceptance criteria for various analytical performance characteristics. Here's a summary:

    Performance CharacteristicMeasurandAcceptance CriteriaReported Device Performance (Summary)
    Limit of Blank (LoB)WBCN/A (implied clinical relevance)$0.1 \times 10^3/mm^3$
    RBCN/A$0.01 \times 10^6/mm^3$
    HCTN/A0.1 %
    PLTN/A$1 \times 10^3/mm^3$
    Limit of Detection (LoD)WBCN/A (implied clinical relevance)$0.2 \times 10^3/mm^3$
    RBCN/A$0.01 \times 10^6/mm^3$
    HGBN/A0.5 g/dL
    HCTN/A0.2 %
    PLTN/A$4 \times 10^3/mm^3$
    Limit of Quantitation (LoQ)WBC% Total-error < desired total error$0.8 \times 10^3/mm^3$ (accepted)
    RBC% Total-error < desired total error$0.7 \times 10^6/mm^3$ (accepted)
    HGB% Total-error < desired total error0.6 g/dL (accepted)
    HCT% Total-error < desired total error8% (accepted)
    PLT% Total-error < desired total error$42 \times 10^3/mm^3$ (accepted)
    Precision (Repeatability)WBC< 2.5 % CVResults within specifications
    RBC< 2.0 % CVResults within specifications
    HGB< 1.5 % CVResults within specifications
    HCT< 2.0 % CVResults within specifications
    PLT< 5.0 % CVResults within specifications
    LYM%< 10 % CVResults within specifications
    MON%< 20 % CVResults within specifications
    GRA%< 4 % CVResults within specifications
    Precision (Reproducibility)WBC7.0% (Low), 5.0% (Normal), 4.0% (High) Total CVResults within specifications
    RBC4.0% (Low), 3.0% (Normal), 3.0% (High) Total CVResults within specifications
    HGB5.0% (Low), 4.0% (Normal), 3.0% (High) Total CVResults within specifications
    HCT5.0% (Low), 4.5% (Normal), 4.0% (High) Total CVResults within specifications
    MCV4.0% (Low), 3.0% (Normal), 2.5% (High) Total CVResults within specifications
    MCH7.0% (Low), 4.5% (Normal), 4.0% (High) Total CVResults within specifications
    MCHC7.0% (Low), 4.5% (Normal), 4.0% (High) Total CVResults within specifications
    RDW5.0% (Low), 5.0% (Normal), 5.0% (High) Total CVResults within specifications
    PLT15.0% (Low), 10.5% (Normal), 7.0% (High) Total CVResults within specifications
    LYM%8.0% (across levels) Total CVResults within specifications
    MON%15.0% (Low), 14.0% (Normal/High) Total CVResults within specifications
    GRA%12.0% (Low), 4.0% (Normal), 3.0% (High) Total CVResults within specifications
    LYM#8.0% (across levels) Total CVResults within specifications
    MON#15.0% (Low), 14.0% (Normal/High) Total CVResults within specifications
    GRA#12.0% (Low), 4.0% (Normal), 3.0% (High) Total CVResults within specifications
    Linearity / AMRWBCN/A (implied linear relationship across range)0.8 - 100 ($10^3/mm^3$) - exhibits linearity across claimed range
    RBCN/A0.7 - 8 ($10^6/mm^3$) - exhibits linearity across claimed range
    PLTN/A42 - 2200 ($10^3/mm^3$) - exhibits linearity across claimed range
    HGBN/A0.6 - 24.0 (g/dL) - exhibits linearity across claimed range
    HCTN/A8.0 - 70.0 (%) - exhibits linearity across claimed range
    Carry-overWBC< 1%All carry-over results within specifications
    RBC< 1%All carry-over results within specifications
    HGB< 1%All carry-over results within specifications
    PLT< 1%All carry-over results within specifications
    Interfering SubstancesAllBias remained below acceptable limit, no significant interferenceNo significant interference observed for urea, bilirubin, lipemia, hemolysis. Yeast affects WBC counts. Megakaryoctes and Parasites are potential interferents for WBC and Monocytes counts respectively.
    Sample Stability (2-8°C)WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT48 hoursAll data passed specifications
    RDW36 hoursAll data passed specifications
    MPV24 hoursAll data passed specifications
    LYM%, LYM#, MON%, MON#, GRA%, GRA#24 hoursAll data passed specifications
    Sample Stability (20-24°C)WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT36 hoursAll data passed specifications
    RDW10 hoursAll data passed specifications
    MPV24 hoursAll data passed specifications
    LYM%, LYM#, MON%, MON#, GRA%, GRA#8 hoursAll data passed specifications
    Comparability (vs. Predicate)All relevant parametersBias acceptance criteria met (at low, mid, high distribution points)Acceptance criteria met for all measurands at all levels.
    Comparability (Sampling Methods)All relevant parametersBias acceptance criteria met (at low, mid, high distribution points)Acceptance criteria met for all measurands at all levels.
    Comparability (Anticoagulant Types)All relevant parametersBias acceptance criteria met (at low, mid, high distribution points)Acceptance criteria met for all measurands at all levels.
    Clinical Sensitivity/SpecificityWBC differential count, abnormal sample detectionAcceptable sensitivity, specificity, PPV, NPV; acceptable comparison to manual microscopy ("envelope" criteria: 95% and 99% CI)Acceptable performances in detecting abnormal samples, good sensitivity, acceptable PPV & NPV. Acceptable WBC differential analysis comparison. Data demonstrates accuracy.
    Reference IntervalAll quantitative parametersNonparametric data analysis; lower and upper limits enclosing 95% of values from reference population with 90% CI for limits.Established reference intervals for males/females are provided and not significantly different between OT/CT models.

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

    • Limit of Blank (LoB): 60 repeated measurements of 5 different plasma samples (total).
    • Limit of Detection (LoD): Six samples (very low concentration) run 10 times over several days, resulting in 60 results.
    • Limit of Quantitation (LoQ): Between 3 to 6 samples per level, run at least 5 times each (40 replicates per level in total).
    • Precision (Repeatability): 12 normal and 10 abnormal fresh whole blood samples (22 samples total), each run 10 consecutive times.
    • Precision (Reproducibility): Three levels (High, Normal, Low) of one single lot of control material, run in duplicate, twice a day, for a minimum of 18 days.
    • Linearity / Assay's Measuring (Reportable) Range: Commercial kits, each level run in replicates of four (n=4).
    • Carryover: Alternating high and low concentration samples, tested in duplicate.
    • Interfering Substances (By addition): Samples to which potential interferents were added.
    • Interfering Substances (By comparison): Representative patient specimens and a control sample (without interferent), 10 to 20 samples in each group.
    • Sample Stability: 11 whole venous blood specimens. Provenance: One site in France.
    • Comparability with Predicate Device: 179 whole blood specimens from adult patients. Provenance: Four test sites in the US. Retrospective/Prospective: Not explicitly stated, but "analyzed at four test sites" suggests either prospective collection for the study or retrospective use of stored samples.
    • Comparability between Sampling Methods: 237 whole blood specimens from adult patients. Provenance: One test site in France. Retrospective/Prospective: Not explicitly stated.
    • Comparability between Anticoagulant Types: 52 normal and pathological blood specimens. Provenance: Three sites in the US. Retrospective/Prospective: Prospectively collected specifically for this study.
    • Clinical Sensitivity / Specificity: 100 normal and 100 pathological samples (200 samples total). Provenance: Left-over samples from both hospital and private independent clinical laboratories in France. Retrospective/Prospective: Retrospective (left-over samples).
    • Reference Interval: 275 (135 male and 140 female) normal adult samples. Provenance: One test site in the US. Retrospective/Prospective: Not explicitly stated.

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

    For the Clinical Sensitivity / Specificity study:

    • Number of experts: 2 readers.
    • Qualifications: Implied to be experts capable of performing "manual slide microscopy for differential count and morphological appreciation" and "400-cell reference differential count (200 cells per reader, 2 readers) on each sample following the procedure discussed in CLSI H20-A2." Specific credentials (e.g., "radiologist with 10 years of experience") are not provided, but CLSI H20-A2 refers to established laboratory practices for manual differential counts, implying qualified laboratory personnel or pathologists.

    For other studies, the ground truth was established by reference methods or validated external kits/controls, not explicitly reported "experts" in the same way.

    4. Adjudication method for the test set

    For the Clinical Sensitivity / Specificity study, based on CLSI H20-A2, an adjudication method of 200 cells per reader (2 readers) for a 400-cell reference differential count was used. This implies an independent assessment by two readers, likely followed by consensus or a pre-defined method for resolving discrepancies if a combined 400-cell count is performed. The wording "200 cells per reader, 2 readers" suggests contribution to a larger total count.

    For other studies, the ground truth was established by objective measurements (e.g., using reference instruments, calibrated kits) rather than subjective 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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance was not conducted or reported in this document. This device is an automated hematology analyzer, not an AI-based assistance tool for human readers. The clinical sensitivity/specificity study compares the device's performance to manual microscopy, which serves as a ground truth or reference method, not as a study of human reader improvement with AI.

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

    Yes, the studies are primarily of the device's standalone performance. The ABX Micros ES 60 is an automated hematology analyzer designed to perform cell counts and differentials without continuous human intervention in the analysis process. All the analytical performance studies (LoB, LoD, LoQ, Precision, Linearity, Carryover, Interfering substances, Sample Stability) and comparability studies (vs. predicate, sampling methods, anticoagulant types) evaluate the algorithm's performance in isolation or against another automated device. The clinical sensitivity/specificity study compares the algorithm's output to a manual reference method, which is used to establish ground truth, but the device itself operates in a standalone manner.

    7. The type of ground truth used

    • LoB, LoD, LoQ, Precision, Linearity, Carryover: Ground truth established through the use of validated internal methods, reference materials, commercial linearity kits, and control materials. For LoQ, it's defined by acceptable % Total-error comparison to a "desired total error for each measurand."
    • Interfering substances: Established by "paired-difference testing" against a control portion of the sample or by comparison to a reference device (Micros 60) for bias.
    • Sample Stability: Baseline measurements (T0) from the device itself serve as the reference for subsequent time points.
    • Comparability with Predicate Device: The predicate device, ABX Micros 60 (K030799), served as the reference for comparison.
    • Comparability between Sampling Methods: One model of the device (CT) served as the reference for the other (OT), or vice-versa, to ensure internal comparability.
    • Comparability between Anticoagulant Types: The device's own measurements on K2EDTA vs K3EDTA samples.
    • Clinical Sensitivity / Specificity: Established by manual slide microscopy for differential count (400-cell reference differential count by 2 readers) and morphological appreciation, following CLSI H20-A2. The predicate ABX Micros 60 was also used for quantitative CBC parameters in this context.
    • Reference Interval: Based on a "nonparametric data analysis method" using results from a large population of normal adult samples, following CLSI EP28-A3. This is statistical determination from representative outcomes data from a healthy population.

    8. The sample size for the training set

    The document does not provide information on the sample size used for the training set. The studies reported are analytical and clinical validation studies for a completed device, typically occurring after a device's development and training phases (if machine learning is involved). Given the technology described (impedance, spectrophotometry), it's more likely a rule-based or traditional signal processing algorithm rather than a deep learning model requiring a large labeled training set in the modern sense. Therefore, the concept of a "training set" might not be applicable in the context of typical AI/ML development.

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

    As no training set is mentioned or implied within the context of AI/ML development, information on how its ground truth was established is not available in the document. The device's operation is based on established principles of automated cell counting and sizing (impedance, spectrophotometry) and internal algorithms for parameter calculations, rather than being explicitly described as a machine learning model that undergoes a distinct "training" phase with labeled data.

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