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510(k) Data Aggregation

    K Number
    K954214
    Device Name
    CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
    Manufacturer
    VYSIS
    Date Cleared
    1997-01-21

    (502 days)

    Product Code
    OXP,KIR
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is designed to provide a reliable method for the simultaneous detection and enumeration of X and Y chromosomes in interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).

    Device Description

    The CEP X/Y probe is a combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes for the centromeric region of chromosome X and the satellite III DNA at the Yq12 region of chromosome Y.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Hybridization Efficiency: <2% cells with only one hybridization signalAverage percentage of cells with only one hybridization signal was 0.012% (S.D.=0.015%) on 143 bone marrow specimens.
    Analytical Sensitivity (Limit of Detection): 1.0%1% confidence limit for the 1% specimen was 0.31% for XY and 1.28% for XX. Estimated limit of detection for CEP X/Y is 1.0%.Reproduction study results: 0% XX specimen: 0.00% (s.d.=0.00%) XX nuclei and 0.95% (s.d. 34%) XY nuclei. 1% XY specimen: 0.94% (s.d.=0.32%) XY nuclei and 0.00% (s.d.=0.00%) XX nuclei.
    Analytical Specificity (Cross-hybridization): No cross-hybridization to other chromosome lociNo cross-hybridization to other chromosome loci was observed in any of the 65 metaphase spreads examined; hybridization was limited to the centromere of chromosome X and the Yq12 region of chromosome Y.
    Reproducibility (Inter-day, Inter-observer): (Implicit, based on presented data)The study assessed inter-day and inter-observer reproducibility. Detailed mean, standard deviation, and coefficient of variation (CV) for different specimen levels (0%, 1%, 5%, 95%, 99%, 100% XY/XX) are provided in Table 1. Examples from Table 1: - 1% XY/99% XX: XY Mean=0.88%, SD=0.48%, CV=54.8% - 5% XY/95% XX: XY Mean=4.90%, SD=0.99%, CV=20.2%
    Methods Comparison (Clinical Specimens): Relative sensitivity for donor cell detection in opposite-sex BMTsInterphase FISH analysis identified 141/141* specimens as positive for donor cells (100% relative sensitivity).
    Methods Comparison (Clinical Specimens): Relative specificity for absence of donor cells in like-sex BMTs (Interphase FISH)Interphase FISH designated 149/153 (97.4%) as negative. 4 false positive cases.
    Methods Comparison (Clinical Specimens): Relative specificity for absence of donor cells in like-sex BMTs (Metaphase FISH)FISH metaphase analyses designated 151/153 (98.7%) as negative. Both false positive metaphase cases were the same patients as two of the false positives from interphase.

    Note: The document implicitly defines acceptance criteria through stated performance goals (e.g., "<2% cells with only one signal is a realistic standard of acceptance") or by reporting outcomes that confirm no issues (e.g., no cross-hybridization).

    2. Sample Sizes Used for the Test Set and Data Provenance

    • Hybridization Efficiency: 143 bone marrow specimens.
    • Analytical Specificity: 65 metaphase spreads.
    • Reproducibility: Mixtures with various XY/XX percentages (0%/100%, 1%/99%, 5%/95%, 95%/5%, 99%/1%, 100%/0%). Specific n values for each mixture are in Table 1 (ranging from 10 to 24). Additionally, four bone marrow specimens with approximately 0%/100%, 1%/99%, 5%/95%, and 95%/5% were prepared and analyzed at one site.
    • Methods Comparison (Clinical Specimens):
      • Opposite-sex BMT: 143 patients (72 males and 71 females were recipients of opposite-sex BMTs). 143 specimens collected, but only 141 had metaphase spreads for FISH analysis.
      • Like-sex BMT: 153 patients.
    • Data Provenance: The document does not explicitly state the country of origin. It mentions a "multi-center" study and "three sites" for the clinical specimen comparison. The study is described as a "pivotal study," and the data appears to be retrospective as it involves "bone marrow specimens, which were previously evaluated by standard cytogenetic analysis."

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    The document does not explicitly state the number of experts or their qualifications for establishing ground truth. However:

    • For analytical specificity, the 65 metaphase spreads were "examined sequentially by G-banding to identify chromosomes X and Y, followed by FISH." This G-banding analysis would have been performed by a cytogeneticist.
    • For the Methods Comparison (Clinical Specimens), standard cytogenetic analysis was used as the comparator for previously collected bone marrow specimens. This implies that the ground truth for these clinical specimens was established by cytogeneticists through traditional karyotyping.

    4. Adjudication Method

    The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). It describes "inter-observer" assessments for reproducibility, implying multiple observers, but not a formal adjudication process to resolve discrepancies for ground truth. For the clinical studies, standard cytogenetic analysis served as the established ground truth for comparison.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not done. This study is evaluating a standalone diagnostic kit (a DNA probe kit), not an AI-assisted diagnostic tool.

    6. Standalone Performance Study

    Yes, the studies described are standalone (algorithm/device only) performance studies. The CEP X/Y probe kit is the device, and its performance characteristics (hybridization efficiency, sensitivity, specificity, reproducibility) and agreement with standard cytogenetics are being evaluated. It is not an AI algorithm with a human-in-the-loop.

    7. Type of Ground Truth Used

    • Hybridization Efficiency, Analytical Sensitivity, Reproducibility: These were assessed against known compositions (e.g., 0% XX, 1% XY specimen, various XY/XX mixtures). The "ground truth" here is the expected percentage or presence/absence of signals based on the prepared specimens.
    • Analytical Specificity: Ground truth was established by sequential G-banding to identify chromosomes X and Y.
    • Methods Comparison (Clinical Specimens): The ground truth was established by standard cytogenetic analysis on bone marrow specimens from BMT recipients. This is a well-established diagnostic method.

    8. Sample Size for the Training Set

    The document does not mention a training set in the context of machine learning or AI. This is a DNA probe kit, not an AI model.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for an AI model.

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