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510(k) Data Aggregation

    K Number
    K223670
    Device Name
    MESI mTablet ECG Diagnostic System, MESI mTablet ECG
    Manufacturer
    MESI, Development of Medical Devices, Ltd; MESI, D.O.O.
    Date Cleared
    2023-07-28

    (233 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K160746,K201046,K150289
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function.

    MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations.

    The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information.

    Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

    Device Description

    The MESI mTABLET ECG portable 12 lead resting ECG system is intended to screen cardiac abnormalities. The MESI mTABLET ECG System acquires, permits viewing and storing signals from adult and pediatric patients. The MESI mTABLET ECG is one of several variations of the company's MESI mTABLET system portfolio.

    MESI mTABLET ECG is intended to measure heart activity by ten electrodes placed on the patient body which measure miniscule electrical activity generated by heart muscle depolarizations. This activity is captured and displayed on the MESI mTABLET UNIT. The MESI mTABLET ECG supports acquisition of 10 seconds signal or manual mode with acquisition up to 5 minutes.

    The MESI mTABLET ECG provides analytical statements when configured with the appropriate options. It also comes with Glasgow algorithm for automatic interpretation which offers dagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment.

    AI/ML Overview

    The request asks for specific details about the acceptance criteria and study that proves the device meets them. However, the provided document is a 510(k) summary for an FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a performance study for a new algorithm.

    Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

    The document does not contain:

    • A table of explicit "acceptance criteria" for an algorithm's performance (e.g., sensitivity, specificity thresholds at a certain operating point).
    • Details of a standalone study proving a new algorithm's performance against specific acceptance criteria. The Glasgow algorithm is a commercially available, previously developed and validated algorithm, not a new algorithm developed by MESI D.O.O. for this specific device.
    • Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or MRMC study results related to a new algorithm's diagnostic performance.
    • Training set information for a new algorithm.

    What can be extracted or inferred from the document:

    1. A table of (implied) acceptance criteria and the reported device performance:

    Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met by demonstrating that the device performs "as well as or better than" the predicate device and conforms to recognized standards for electrocardiographs.

    Feature / StandardAcceptance Criteria (Implied)Reported Device Performance (MESI mTABLET ECG)
    Indications for UseEquivalent to predicate (CARDIOLINE HD+ & touchECG) for evaluating and diagnosing cardiac function in adult/pediatric patients.Indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. Measures heart activity via 10 electrodes. Similar to predicate.
    Interpretation AlgorithmUtilizes a clinically accepted algorithm for ECG interpretation.Employs the Glasgow Algorithm for interpretation (same as "touchECG" predicate).
    Safety & PerformanceConformance to relevant medical device standards.Compliant with: EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 60601-2-25, EN 303 446-1, EN 62304, EN 62366, EN ISO 15223-1, EN ISO 10993-1, EN ISO 14971, IEEE/ANSI C63.27, ANSI/AAMI EC53.
    Wireless TechnologyBluetooth 2.1 + EDRBluetooth 2.1 + EDR (identical to CARDIOLINE HD+).
    Data ResolutionSufficient for clinical interpretation.19 bit, 2.5 µV (slightly lower than CARDIOLINE HD+ 20 bit,
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