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510(k) Data Aggregation

    K Number
    K023817
    Device Name
    SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010
    Manufacturer
    CLIO DESIGNS, INC.
    Date Cleared
    2003-06-25

    (222 days)

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

    The SmartShape Body Composition Analyzer is a noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat by body weight.

    Device Description

    The SmartShape Body Composition Analyzer is a hand-held device designed to determine body fat composition. The device offers the user the ability to measure their body fat level and store the data for analvsis. It is programmable for up to 10 separate individuals and uses bioelectric impedance technology for the estimation of percent body fat. The device also includes a clock and alarm function.

    AI/ML Overview

    The provided text describes a 510(k) submission for the SmartShape Body Composition Analyzer 4010. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive de novo clinical studies with predefined acceptance criteria and detailed performance metrics.

    Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    FunctionalityNot explicitly defined with specific numerical thresholds. The implicit criterion is that the device operates as intended for its stated purpose (estimation of percent body fat)."All results were shown to be acceptable." "The SmartShape Body Composition Analyzer was shown to perform as intended."
    ReliabilityNot explicitly defined with specific numerical thresholds. The implicit criterion likely pertains to consistent operation over time and under various conditions."All results were shown to be acceptable."
    RepeatabilityNot explicitly defined with specific numerical thresholds. The implicit criterion suggests that repeated measurements on the same individual under similar conditions should yield consistent results."All results were shown to be acceptable."
    ReproducibilityNot explicitly defined with specific numerical thresholds. The implicit criterion suggests that measurements taken by different users or with different devices (of the same model) under similar conditions should yield consistent results."All results were shown to be acceptable."
    Equivalence to PredicateThe implicit criterion is that the SmartShape Body Composition Analyzer demonstrates "substantial equivalence" in performance to the predicate device (Omron Healthcare, Inc. Body Fat Analyzer Model HBF-306). This typically means that the device performs as well as, or comparably to, the predicate device in its intended use, without raising new questions of safety or effectiveness. Specific statistical metrics for comparison (e.g., correlation coefficients, mean absolute difference) are not provided in this summary."Results of the testing showed that the SmartShape Body Composition Analyzer was equivalent in performance to the predicate device." "The fundamental technical characteristics and indications for use of the SmartShape Body Composition Analyzer are similar to those of the predicate device."

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

    • Sample Size: The document does not specify the sample size used for performance testing. It only states that "Performance testing was conducted..." and "comparison testing was performed using the SmartShape Body Composition Analyzer and the predicate device."
    • Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.

    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. For a body composition analyzer, "ground truth" would typically refer to a gold-standard method for measuring body fat (e.g., DEXA, hydrostatic weighing). The document does not describe the use of such a ground truth or the involvement of experts for this purpose in the performance testing mentioned. The comparison was primarily against a predicate device.

    4. Adjudication Method for the Test Set:

    • This information is not provided. Given the nature of a body composition analyzer and the focus on substantial equivalence, a formal adjudication method by experts is not typically described in this type of submission for the performance tests conducted.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:

    • No, an MRMC comparative effectiveness study was not done. The device (SmartShape Body Composition Analyzer 4010) is an automated device for body fat estimation, not an imaging device requiring human interpretation, and thus MRMC studies are not applicable. The performance testing described is focused on the device's accuracy and equivalence to another device, not on how human readers improve with AI assistance.

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

    • Yes, the performance testing described is inherently a standalone (algorithm only) evaluation of the device. The SmartShape Body Composition Analyzer is a "noninvasive bioimpedance analyzer intended for use in the estimation of percent body fat" and its "software utilizes the impedance data, patient weight, gender, age, and height data to calculate the patient percent body fat." The performance tests conducted evaluated the device's output independently.

    7. The Type of Ground Truth Used:

    • The primary "ground truth" or reference for the performance testing, as described, appears to be the predicate device (Omron Healthcare, Inc. Body Fat Analyzer Model HBF-306). The document directly states: "comparison testing was performed using the SmartShape Body Composition Analyzer and the predicate device. Results of the testing showed that the SmartShape Body Composition Analyzer was equivalent in performance to the predicate device." There is no mention of using a different, independent "gold standard" ground truth (like DEXA or pathology) for the performance evaluation in this summary.

    8. The Sample Size for the Training Set:

    • This information is not provided. Since this is a 510(k) summary and the primary focus is on substantial equivalence, details about algorithm training data (sample size, characteristics, etc.) are generally not included unless they directly impact the substantial equivalence determination. The document describes the device as using "bioelectric impedance technology for the estimation of percent body fat" and "The device software utilizes the impedance data, patient weight, gender, age, and height data to calculate the patient percent body fat," implying an underlying algorithm or formula, but details of its development or training are absent.

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

    • This information is not provided. As with the training set sample size, details on how any ground truth for potential algorithm training was established are not mentioned in this 510(k) summary.
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