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    K Number
    K213011
    Device Name
    Infrared Thermometer (model: E201)
    Manufacturer
    Bioland Technology Ltd
    Date Cleared
    2022-04-05

    (197 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K191570
    Why did this record match?
    Device Name :

    Infrared Thermometer (model: E201)

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

    The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.

    Device Description

    The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features: 1) The device is intended to be used in the homecare environment; 2) The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries; 3) Switching between °C and °F; 4) Multi-functional, can measure ear and forehead temperature; 5) The 32 sets measurement data can be stored, the user can view the previous measurement results; 6) Low battery indication, and auto shut-down within 30s.

    AI/ML Overview

    Here's an analysis of the provided text to extract the acceptance criteria and study information for the Infrared Thermometer (model: E201):

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are primarily derived from the "Measuring accuracy" in the comparison table and the clinical accuracy testing based on ISO 80601-2-56.

    Acceptance Criteria (from "Measuring accuracy" & ISO 80601-2-56)Reported Device Performance (from "Measuring accuracy" & Clinical Accuracy Testing)
    Measuring Accuracy (Device Output vs. Reference)
    ±0.3°C for temperatures between 32.0°C and 34.9°C±0.3°C (32.0°C~34.9°C)
    ±0.2°C for temperatures between 35.0°C and 42.0°C±0.2°C (35.0°C~42.0°C)
    ±0.3°C for temperatures between 42.1°C and 43.0°C±0.3°C (42.1°C~43.0°C)
    Clinical accuracy and repeatability within acceptable scope specified in standard ISO 80601-2-56Clinical accuracy and repeatability met requirements per referenced standards (ISO 80601-2-56)

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size: 150 subjects total.
      • 50 subjects in the 0-1 year age group.
      • 50 subjects in the 1-5 years age group.
      • 50 subjects in the over 5 years age group.
    • Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical accuracy study for the E201 infrared thermometer was performed," implying a prospective clinical study. It does not mention retrospective data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The text only states that the "reference body site of infrared thermometer is oxter (axillary)" and that clinical accuracy/repeatability testing was performed. It doesn't specify how many experts established the ground truth or their qualifications.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    This is not applicable as the device is an Infrared Thermometer, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    This is not applicable in the context of an infrared thermometer. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated directly against a reference body site.

    7. The Type of Ground Truth Used

    • Ground Truth: The "oxter (axillary)" temperature as the reference body site.

    8. The Sample Size for the Training Set

    This information is not applicable as this is a traditional medical device (infrared thermometer), not an AI/ML device that requires a distinct training set. The device's algorithms are based on established physical principles of infrared radiation and temperature conversion, calibrated during manufacturing, rather than being "trained" on a dataset in the AI sense.

    9. How the Ground Truth for the Training Set Was Established

    This is not applicable for the same reasons as point 8. The device's calibration and accuracy are verified against known temperature standards and clinical measurements (using oxter temperature as reference), not established through a "training set" with ground truth in the AI sense.

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