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510(k) Data Aggregation

    K Number
    K092118
    Device Name
    ANGIOGRAPHIC CATHETER, MODEL ANGIOS
    Manufacturer
    Oscor Inc.
    Date Cleared
    2010-01-13

    (183 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The model Angios angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedure.

    Device Description

    Not Found

    AI/ML Overview

    There is no information in the provided document about the acceptance criteria or a study that proves the device meets specific performance criteria. The document is an FDA 510(k) clearance letter for the Angiographic Catheter, Model Angios™. It confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use, but it does not detail performance statistics or study results.

    Therefore, I cannot provide the requested information about:

    1. A table of acceptance criteria and the reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study, if done, and its effect size.
    6. Standalone performance study for the algorithm.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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