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510(k) Data Aggregation

    K Number
    K030203
    Device Name
    LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
    Manufacturer
    LONG WELL ELECTRONICS CORP.
    Date Cleared
    2003-04-21

    (90 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K011652
    Predicate For
    K043414,K052678,K060552
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 10 to 80 years old.

    The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.

    Device Description

    LONG WELL LW-6Dxx Series Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.

    AI/ML Overview

    Acceptance Criteria and Study Details for LONG WELL LW-6Dxx Series Body Fat Analyzer

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state numerical acceptance criteria for the device's performance. Instead, it indicates that the device was compared to a DEXA (Dual energy X-ray absorptiometry) technology, and the outcome and acceptance criteria are qualitative, focusing on statistical and clinical acceptability.

    Acceptance Criteria (Stated)Reported Device Performance
    "clinical repeatability of LONG WELL LW-6Dxx Series Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups.""A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed to validate the performance of the LONG WELL LW-6Dxx Series Body Fat Analyzer... The comparison study demonstrated that the clinical repeatability of LONG WELL LW-6Dxx Series Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups."
    Conformance to applicable standards: IEC 60601-1 and IEC 60601-1-2 requirements (operating specification, Safety & EMC)."In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements."
    Substantial equivalence to predicate device (Omron HBF-306 Body Fat Analyzer K011652)."The LONG WELL LW-6Dxx Series Body Fat Analyzer have the same intended use and similar technological characteristics as Omron HBF-306 Body Fat Analyzer( K011652 )marketed by Omron Healthcare INC. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the LONG WELL LW-6Dxx Series Body Fat Analyzer is substantially equivalent to the predicate devices."

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

    • Sample Size: The document states "Subjects were grouped as male/ female, ages," but does not provide a specific number for the sample size used in the comparison study.
    • Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address is Taiwan, R.O.C., it is plausible the study was conducted there, but this is not confirmed. The data appears to be prospective as a "comparison study" was performed to validate the device's performance.

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

    The document does not mention the use of experts to establish ground truth. The comparison study used DEXA technology as the comparator, implying DEXA results were considered the "ground truth" or reference standard.

    4. Adjudication Method for the Test Set

    Since human experts were not mentioned as establishing ground truth, there was no adjudication method described for the test set. The validation was based on comparison with DEXA.

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

    No (MRMC) comparative effectiveness study was mentioned. The study described is a comparison study against DEXA technology, not a study evaluating human readers with and without AI assistance.

    6. Standalone Performance Study

    Yes, a standalone performance study was done. The "comparison study with device that use DEXA (Dual energy X-ray absorptiometry) technology" was performed to validate the performance of the LONG WELL LW-6Dxx Series Body Fat Analyzer directly. This evaluates the algorithm's performance without a human in the loop, as it compares the device's output to the reference standard.

    7. Type of Ground Truth Used

    The ground truth used was DEXA (Dual energy X-ray absorptiometry) measurements. DEXA is a well-established and highly accurate method for body composition analysis, often considered a "gold standard" or reference standard in research.

    8. Sample Size for the Training Set

    The document does not provide any information regarding a training set or its sample size. This suggests the comparison study was primarily for validation, and details about the development and training of the device's algorithm are not included in this summary.

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

    As no training set is mentioned, there is no information on how ground truth for a training set was established.

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