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510(k) Data Aggregation

    K Number
    K123446
    Device Name
    TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
    Manufacturer
    United States GTM Medical Devices, Inc.
    Date Cleared
    2012-12-07

    (29 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K201302
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure monitoring system. It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory conditions.

    However, the document does not contain any information regarding:

    1. Acceptance criteria or reported device performance.
    2. Sample sizes or data provenance for any studies.
    3. Number or qualifications of experts used to establish ground truth.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance studies.
    7. Type of ground truth used.
    8. Sample size for training sets.
    9. How ground truth for training sets was established.

    The document focuses solely on the regulatory clearance process and the device's indications for use, without delving into the detailed technical or clinical study results that would contain the information you are asking for.

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