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510(k) Data Aggregation

    K Number
    K020939
    Device Name
    MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    2002-05-17

    (56 days)

    Product Code
    LTT,JWY
    Regulation Number
    866.1640
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K963641
    Predicate For
    K202423
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To determine bacterial susceptibility to Tetracycline
    For determining antimicrobic susceptibility with aerobic streptococci, including Streptococcus pneumoniae

    Device Description

    The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
    The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the MicroScan® MICroSTREP plus™ Panel with Tetracycline, based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Acceptable performance for streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.Overall Essential Agreement of 92.9% for Tetracycline when compared with the frozen Reference panel.
    Acceptable reproducibility and precision with Tetracycline.Reproducibility testing demonstrated acceptable reproducibility and precision with Tetracycline.
    Acceptable Quality Control results for Tetracycline.Quality Control testing demonstrated acceptable results for Tetracycline.

    Study Details

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

      • The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the specific number of isolates used in the test set is not provided in the document.
      • Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "external evaluation," suggesting it was not conducted internally by the manufacturer. It's a prospective evaluation comparing the new panel against a reference standard.

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

      • This information is not provided in the document. The ground truth was established by an "NCCLS frozen Reference Panel," which implicitly suggests expert-defined reference standards, but without specifying the number or qualifications of experts involved in its establishment.

    3. Adjudication method for the test set:

      • This information is not provided in the document. The comparison was made against a reference panel, but the method of discrepancy resolution (adjudication) if any, is not described.

    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, an MRMC comparative effectiveness study was not done. This device is a quantitative and/or qualitative antimicrobial agent susceptibility panel, not an AI-assisted diagnostic tool for human readers.

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

      • This device is a diagnostic panel that requires visual interpretation. The document states, "panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert," and "the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth." Therefore, it is not a standalone algorithm-only device nor is it explicitly described as having an 'algorithm only' performance study. The core of its performance relies on the visual manual reading against the reference.

    6. The type of ground truth used:

      • The ground truth was established by an NCCLS frozen Reference Panel. This type of ground truth represents a highly standardized and accepted method for determining antimicrobial susceptibility, implicitly involving expert-defined and validated reference standards for MIC determination.

    7. The sample size for the training set:

      • The document does not mention a training set. This type of device (a diagnostic panel for antimicrobial susceptibility) is typically validated against a reference method rather than developed using a machine learning training set.

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

      • As no training set is mentioned, this information is not applicable.
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