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510(k) Data Aggregation

    K Number
    K941784
    Device Name
    VENTANA ANTI-CD8 PRIMARY ANTIBODY
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-02-14

    (1040 days)

    Product Code
    DEH
    Regulation Number
    866.5550
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ventana Medical Systems. Inc. developed Ventana Anti-CD8 (Clone SFC121Thy2D3) for use on the Ventana ES automated immunohistochemistry system.

    Device Description

    Ventana Anti-CD8 (Clone SFCI21Thy2D3) for use on the Ventana ES automated immunohistochemistry system.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for Ventana Anti-CD8 (Clone SFC121Thy2D3), structured as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Specific Staining IntensityStaining occurred on the surface of lymphoid cells from normal tonsil, thymus, and blood. 9 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissues (9 of 9 blood smears, 4 of 4 peripheral blood lymphocyte cytospins, 4 of 4 thymus tissues and 10 of 10 tonsil tissues) stained positively.
    Background StainingNegative control tissue was all negative. No inappropriate staining of tissues. The negative control run with each tissue gave negative results.
    Sensitivity (Appropriate staining of lymphoid origin cells)Appropriate staining of cells of lymphoid origin.
    Specificity (No staining of non-lymphoid origin cells)No staining of cells of non-lymphoid origin.
    Inter-run Reproducibility (Consistent staining across different runs)All ten slides (using frozen tonsil as positive control) stained positively for CD8 antigen across 10 different instrument runs.
    Intra-run Reproducibility (Consistent staining within a single run)All ten slides (using same frozen tonsil tissue) stained positively for CD8 antigen within one run.
    Equivalence to existing antibodies/published dataThe Ventana data in this study agrees with the data published by Reinherz et.al. and Deegan.

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

    • Sample Size:
      • T cell lymphomas: 9
      • Normal blood smears: 9
      • Peripheral blood lymphocyte cytospins: 4
      • Thymus tissues: 4
      • Tonsil tissues: 10
      • Negative control tissue: (Number not specified, but stated as "all negative")
      • Inter-run reproducibility: 10 (frozen tonsil)
      • Intra-run reproducibility: 10 (frozen tonsil)
    • Data Provenance: Samples were "obtained from excess tissues obtained for reasons other than the present study." This indicates a retrospective collection of samples. The country of origin is not specified.

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

    • Number of Experts: 1
    • Qualifications: "a qualified pathologist" (specific experience level not provided).

    4. Adjudication Method for the Test Set

    • The text describes evaluation by "a qualified pathologist," implying a single reader's assessment. There is no mention of an adjudication method such as 2+1 or 3+1.

    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, an MRMC comparative effectiveness study was not done. This study evaluates an immunohistochemistry reagent, not an AI system or device intended for a human-in-the-loop diagnostic process. The reported study focuses on the performance of the antibody in staining tissues, not on human reader performance with or without assistance.

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

    • Yes, a standalone study was done. The device being evaluated is an anti-CD8 antibody used on an automated immunohistochemistry system. The study assesses the performance of this reagent (antibody + automated system) in staining tissues, which is a standalone function where the "algorithm" is the biochemical reactivity of the antibody and the automation of the system. The evaluation by the pathologist is to assess the staining, not to use the device as a diagnostic aid in a human-in-the-loop scenario.

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

    • The ground truth was established by pathological evaluation of the tissue samples by a qualified pathologist, assessing "specific staining intensity and background staining." The text also refers to existing published literature and previous knowledge (Reinherz et al., Deegan) as part of the understanding of what constitutes "appropriate staining" for CD8.

    8. The sample size for the training set

    • This information is not provided. The study described here is evaluating the performance of the antibody; there is no mention of a "training set" in the context of machine learning or algorithm development. The antibody's specificity and reactivity would have been developed through prior R&D, but the details of that are not in this summary.

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

    • This information is not provided as there is no training set described.
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