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    K Number
    K140681
    Device Name
    BELTER INFRA-RED EAR THERMOMETER
    Manufacturer
    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
    Date Cleared
    2014-08-21

    (156 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K111637
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE

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

    The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.

    Device Description

    The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.

    AI/ML Overview

    This document describes the acceptance criteria and study results for the Belter Infra-red Ear Thermometer.

    1. Table of Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance Value (ISO80601-2-56)Reported Device Performance
    Laboratory Accuracy (bench)≤ 0.2 ℃0.01 ~ 0.19 ℃
    Clinical Repeatability≤ 0.3 ℃0.07 ~ 0.11 ℃
    Structural IntegrityMeets requirementsMeets requirements

    2. Sample Size and Data Provenance

    The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "bench test report" and "clinical repeatability."

    3. Number of Experts and Qualifications

    This information is not provided in the document.

    4. Adjudication Method

    This information is not provided in the document.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a thermometer, not an AI-assisted diagnostic tool.

    6. Standalone Performance

    Yes, a standalone performance assessment was done, evaluating the device's accuracy and repeatability without human intervention. The reported values for laboratory accuracy and clinical repeatability are standalone metrics.

    7. Type of Ground Truth Used

    The ground truth for accuracy was established against a reference standard in laboratory settings (bench tests) and through clinical repeatability measurements in a clinical setting. The specific method for determining the "true" temperature for comparison during clinical repeatability is not detailed, but it typically involves comparison to another validated thermometer or a set protocol.

    8. Sample Size for Training Set

    This information is not applicable as this is not an AI/ML device requiring a training set.

    9. How Ground Truth for Training Set Was Established

    This information is not applicable as this is not an AI/ML device requiring a training set.

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