LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101569
    Device Name
    V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2011-03-01

    (270 days)

    Product Code
    DPS,ELE
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K071085,K060766
    Predicate For
    K131572,K172221
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The V-TRUST TD-2202 portable ECG recorder is intended for recording and displaying ECG data of adult patients who are concerned about their heart rhythm. A patient can either equip a five lead-wires ECG cable to take a long term monitoring; or choose to use event reading option when feeling any heart condition occur. This recorder allows the patient to record their ECG data in SD memory card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.

    The V-TRUST TD-2202 portable ECG recorder can also wirelessly transmit recorded ECG to a Bluetooth-enabled computer.

    Device Description

    The V-TRUST TD-2202 Portable ECG Recorder provides a long-period recording with multiple channels and transient recording with single channel for individual use. This portable electrocardiograph has a touch screen interface, TFT (Thin Film Transistor)-LCD waveform display, one SD (Secure Digital) memory card insertion port, data transmission via Bluetooth, and 24 hours of continuous recording (in non-compressed format).

    AI/ML Overview

    The provided text describes a 510(k) summary for the V-TRUST TD-2202 Portable ECG Recorder, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and specific performance metrics.

    Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided document.

    Here's a breakdown of what can be extracted and what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Not Explicitly Stated)Reported Device Performance
    Bench Tests:IEC 60601-1, IEC 60601-1-2 Medical, and AAMI EC 38 standards met. These standards likely cover:
    - Electrical safety- Conforms to standards
    - Electromagnetic compatibility (EMC)- Conforms to standards
    - Accuracy of ECG recording signals- Conforms to standards
    - Frequency response- Conforms to standards
    - Patient isolation- Conforms to standards
    - Other performance requirements for ECG devices- Conforms to standards
    Clinical Performance:Not explicitly stated in terms of specific metrics (e.g., sensitivity, specificity for arrhythmia detection). The document implies clinical performance through substantial equivalence to predicate devices for recording and display of ECG data for analysis by a physician.

    Explanation: The document states that "The bench tests were performed according to IEC 60601-1, IEC 60601-1-2 Medical and AAMI EC 38, and the results demonstrate that the V-TRUST TD-2202 Portable ECG Recorder conform to the standards and is safe and effective." This means the device met the requirements outlined in these consensus standards, which serve as the "acceptance criteria" for basic device performance, safety, and effectiveness. However, the exact numerical performance metrics against these standards are not provided in this summary.

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

    • Sample Size: Not specified. Bench testing typically involves testing multiple units of the device; no patient data is mentioned for performance evaluation beyond the device's ability to record.
    • Data Provenance: Not applicable for the described bench tests. The tests are performed on the device itself, not on patient data.

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

    • Not applicable. The "ground truth" for bench tests is defined by the technical specifications and requirements within the IEC and AAMI standards. No human experts are mentioned for establishing ground truth in this context.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable. Bench tests don't typically involve adjudication in the way clinical studies do. Compliance with standards is usually a pass/fail outcome based on measurement against defined thresholds.

    5. 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. This device is a portable ECG recorder, not an AI-powered diagnostic tool. The document does not describe any MRMC study or AI assistance. Its purpose is to record and display ECG data for analysis by a physician, not to interpret it automatically.

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

    • No. This device's primary function is data acquisition and display. There is no mention of an algorithm performing standalone interpretation.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • For the bench tests, the "ground truth" is adherence to the technical specifications and performance limits defined by the referenced international standards (IEC 60601-1, IEC 60601-1-2, and AAMI EC 38). These standards establish benchmarks for electrical safety, EMC, and fundamental ECG signal characteristics.

    8. The sample size for the training set:

    • Not applicable. This device does not appear to use machine learning or AI that would require a "training set."

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

    • Not applicable, as there is no training set mentioned.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1