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510(k) Data Aggregation

    K Number
    K132140
    Device Name
    DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
    Manufacturer
    DUTECK INDUSTRIAL CO., LTD.
    Date Cleared
    2014-02-04

    (208 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K992327
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:

    The device display body temperature in digital format at LCD
    The device make intended contact with patient in 2 ways
    (1) Surface contact: armpit.
    (2) Invasive contact: oral.
    The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
    The device is used in ENVIRONMENT of room temperature and normal environment condition.

    Device Description

    Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.

    AI/ML Overview

    The provided document does not contain a study or data to establish acceptance criteria for the Duteck (micHealth) Digital Clinical Thermometer, DT2306 series. Instead, it presents a 510(k) summary claiming substantial equivalence to a predicate device (Duteck Digital Clinical Thermometer K992327).

    The document focuses on comparing the technical characteristics and intended use of the new device with its predicate device. It states that the new device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use." However, it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided text.

    Here is an analysis of what can be extracted or inferred from the document regarding the acceptance criteria and performance, and why the other points cannot be addressed:

    1. Table of Acceptance Criteria and Reported Device Performance

    Not available in the document. The document only provides technical specifications for both the new device and the predicate device. It does not list specific performance metrics with associated acceptance criteria and the actual performance achieved against those criteria in a study.

    Element of ComparisonAcceptance Criteria (Not Explicitly Stated as AC)Reported Device Performance (DT2306)
    Displayed Temperature Range(Implied: 32.00°C~42.00°C)32.00°C42.00°C(89.60°F109.20°F)
    Operation Environment(Implied: 16.00°C~40.00°C)16.00°C40.00°C(60.80°F104.00°F)
    Display Resolution(Implied: ±0.01°C/°F)±0.01°C/°F
    Response Time(Implied: ~4 seconds, based on comparison)4 second

    Note: The "Acceptance Criteria" column above is based on the reported characteristics of the new device and the comparison to the predicate, as explicit acceptance criteria are not provided. The document states that the device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use," but does not detail the results of these tests or the specific pass/fail criteria.

    Study Details (Not Available in the Document)

    The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed study results for establishing performance against novel acceptance criteria. It refers to "performance and safety. testing" but provides no specifics.

    Therefore, the following information cannot be provided from the given text:

    1. Sample size used for the test set and the data provenance: Not mentioned.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
    3. Adjudication method for the test set: Not mentioned.
    4. 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: Not applicable. This device is a digital clinical thermometer, not an AI-powered diagnostic tool engaging with human readers.
    5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a non-AI device. While its performance is standalone, no separate analysis is provided given the information.
    6. The type of ground truth used: Not mentioned. For a thermometer, the "ground truth" would likely involve comparison to a highly accurate reference thermometer, but this is not detailed.
    7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the typical sense.
    8. How the ground truth for the training set was established: Not applicable.
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