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510(k) Data Aggregation

    K Number
    K052794
    Device Name
    ETI-MAX 3000
    Manufacturer
    DIASORIN, INC.
    Date Cleared
    2006-03-31

    (179 days)

    Product Code
    JJF
    Regulation Number
    862.2170
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K922081,K973177
    Why did this record match?
    Device Name :

    ETI-MAX 3000

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

    The ETI-MAX 3000™ is a fully automated microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000 ™ instrument were assessed using the DiaSorin ANAScreen ELISA kit, the DiaSorin Anti-SS-A (Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen Kit.

    Device Description

    The ETI- MAX 3000™ is a fully automated, microtiter plate laboratory analyzer performing the complete sample processing (barcode scanner, predilution station, pipetting station, plate transport, wash station, incubators and photometric measurement). The instrument is controlled by the Windows PC software ETI- MAX 3000™. This software allows the user to process the pre-defined assays of DiaSorin.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the DiaSorin ETI-MAX 3000™ Automated Laboratory Analyzer, based on the provided text:

    Acceptance Criteria and Device Performance

    The acceptance criteria for the DiaSorin ETI-MAX 3000™ are implicitly defined by the demonstration of equivalent performance to manual methods for various analytical parameters of previously cleared immunology assays. The performance metrics reported are specific to analytical sensitivity, linearity, reproducibility/precision, carry-over, and method comparison/correlation.

    Acceptance Criteria CategorySpecific Acceptance Criterion (Implied by Study Design)Reported Device Performance
    Analytical SensitivityTo be determined according to NCCLS guideline EP-17A, indicating that the device should be able to determine limits of detection and quantitation comparable to the manual method.Analytical sensitivity was determined for the manual assays on the ETI-MAX 3000™ by following NCCLS guideline EP-17A. (Specific values are not provided, but the method was followed, implying acceptable determination.)
    LinearityInterpretations (positive, equivocal, or negative) should be within +/- 1 dilution from the interpretations for the same dilutions using the manual method across the full assay range.The ETI-MAX 3000™ interpretations (positive, equivocal or negative) were within +/- 1 dilution from the interpretations for the same dilutions using the manual method, across the full assay range for each product.
    Reproducibility/PrecisionWithin-run, between-run, total, and instrument-to-instrument %CVs (Coefficient of Variation) should be within acceptable limits as demonstrated through a multi-site study using coded samples with known characteristics, particularly for samples near the cut-off. (Specific numeric thresholds are not explicitly stated, but the tables provide the observed values, which are presumably deemed acceptable for demonstrating equivalence).ANA Screen: Overall Total %CVs for 8 samples across 3 sites ranged from 2.0% to 50.6%. Instrument to instrument %CVs ranged from 3.2% to 18.6%.
    Precision for ANA Screen Kit: Overall Total %CVs for 8 samples across 3 sites ranged from 4.2% to 23.4%. Instrument to instrument %CVs ranged from 1.6% to 8.3%.
    Precision for Anti-SS-A (Ro) (Qualitative): Overall Total %CVs for 8 samples across 3 sites ranged from 4.1% to 43.4%. Instrument to instrument %CVs ranged from 2.5% to 12.2%. (Note: The provided text abruptly ends the Anti-SS-A (Ro) table before all samples are shown, and then a truncated table continues with "..." followed by another "Anti-SS-A (Ro)" section, which seems to combine the quantitative and qualitative data. Assuming the "Table of Precision for Anti-SS-A (Ro)" contains the qualitative data and the last table contains the semi-quantitative agreements.)
    Carry-overNo detectable carry-over from the pipettor or washer.Results indicated there was no carry over from the pipettor or washer for all three assays.
    Method Comparison/Correlation (Qualitative)High percent agreement (positive, negative, and overall) with the manual assay results, with acceptable 95% exact confidence intervals.ANA Screen: Positive Agreement: 100.0% (62/62), Negative Agreement: 96.7% (88/91), Overall Agreement: 94.3% (150/159). (Note: The table layout has some issues, but calculated from the raw counts: (62+88+4) / 159 = 154/159 = 96.86% overall agreement, with 62/64 positive agreement and 88/88 negative agreement ignoring equivocal.)
    ENA Screen: Positive Agreement: 93.7% (59/63), Negative Agreement: 100.0% (92/92), Overall Agreement: 95.6% (151/159).
    Anti-SS-A (Ro) Qualitative: Positive Agreement: 100.0% (55/55), Negative Agreement: 100.0% (104/104), Overall Agreement: 100.0% (159/159) with corresponding exact 95% CIs.
    Method Comparison/Correlation (Semi-Quantitative)High percent agreement (positive, negative, and overall) with the manual assay results, with acceptable 95% exact confidence intervals.Anti-SS-A (Ro) Semi-Quantitative: Positive Agreement: 100.0% (54/54), Negative Agreement: 99.0% (104/105), Overall Agreement: 99.4% (158/159) with corresponding exact 95% CIs.

    Study Details

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

      • Reproducibility/Precision: 8 frozen repository serum samples were tested with 4 replicates per run over 5 days, at 3 different sites, using 3 different instruments. This means for each site, per sample, there were 20 individual results (4 reps/day * 5 days). The total number of measurements for precision is (8 samples * 20 measurements/sample * 3 sites) = 480 measurements per assay. The text indicates "N" could be 20 per site per sample.
      • Method Comparison/Correlation: 159 retrospective samples per assay were used.
      • Data Provenance:
        • Precision: The coded panel was prepared at DiaSorin (Stillwater, MN, USA), and testing was conducted at two external US laboratories and at DiaSorin Inc in Stillwater, MN. This indicates US-based data.
        • Method Comparison: "Retrospective samples (w/clinical history)" were used. The country of origin is not specified, but given DiaSorin is based in Minnesota, it is likely US-based or at least North American.

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

      • The ground truth for all performance evaluations (linearity, reproducibility, carry-over, and method comparison) was established by the "manual method" of the three FDA previously cleared immunology assays. The study design does not involve human experts establishing ground truth for the samples themselves. Instead, the manual method serves as the reference standard against which the automated device's performance is compared.

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

      • Not applicable. This device is an automated laboratory analyzer, and its performance is compared to a manual laboratory method, not interpreted by human readers requiring adjudication.

    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 MRMC study was done, as this is an automated analyzer, not an AI-assisted diagnostic tool that relies on human interpretation improving with AI. The comparison is between an automated system and a manual laboratory process.

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

      • Yes, the performance study is primarily a standalone evaluation of the DiaSorin ETI-MAX 3000™ automated system compared to manual methods. There is no human-in-the-loop aspect described; the device performs the assay steps and provides quantitative/qualitative results directly.

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

      • The ground truth used for comparison was the results obtained from the manual method of the FDA-previously cleared immunology assays. This acts as the "reference standard" for evaluating the automated system. The samples themselves were "frozen repository serum samples" or "retrospective samples (w/clinical history)."

    7. The sample size for the training set:

      • The document does not describe a "training set" in the context of machine learning or AI. This device is an automated instrument, not a learning algorithm. Its operation is based on pre-programmed protocols for known assays, not trained data.

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

      • Not applicable, as there is no training set in the context of machine learning/AI for this device. The device's functionality is based on its mechanical and software design to execute laboratory protocols.
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