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510(k) Data Aggregation

    K Number
    K013539
    Date Cleared
    2002-01-17

    (85 days)

    Product Code
    Regulation Number
    870.1130
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS

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

    Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter for the Rossmax MediPro Model 100f, 200f, and 300f Blood Pressure Monitors does not contain the detailed information required to fulfill the request. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device and does not provide specifics about the acceptance criteria, study methodology, or performance data.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth and their qualifications
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone performance
    7. Type of ground truth used
    8. Sample size for the training set
    9. How the ground truth for the training set was established

    This type of detailed study information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

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