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    K Number
    K170666
    Device Name
    The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
    Manufacturer
    Joytech Healthcare Co., Ltd.
    Date Cleared
    2017-11-22

    (261 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K121355
    Predicate For
    K092819
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.

    Device Description

    The wrist-type Fully Automatic Digital Blood Pressure Monitors with an inflatable cuff wrapping around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study details for the JOYTECH Healthcare Co., Ltd. Wrist-type Fully Automatic Digital Blood Pressure Monitor, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (ISO 81060-2:2013)Reported Device Performance (Systolic Blood Pressure)Reported Device Performance (Diastolic Blood Pressure)
    Criterion A: Mean difference ≤ ±5 mmHg, with standard deviation of differences ≤ 8 mmHg (between test device and reference method)Method 1: Average = 0.84 mmHg (< ±5 mmHg), SD = 5.25 mmHg (<8 mmHg)Method 1: Average = 0.21 mmHg (< ±5 mmHg), SD = 4.92 mmHg (<8 mmHg)
    Criterion B: Standard deviation ($s_m$) of averaged paired determinations for each subject must meet criteria in ISO 81060-2 Table 1 (max permissible $s_m$ as a function of mean difference, $\bar{x}_n$)Method 2: Average = 0.84 mmHg (< ±5 mmHg), SD = 4.52 mmHg (<6.95 mmHg for $\bar{x}_n$ of 0.84 - interpolated from table)Method 2: Average = 0.21 mmHg (< ±5 mmHg), SD = 4.36 mmHg (<6.95 mmHg for $\bar{x}_n$ of 0.21 - interpolated from table)

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

    • Sample Size: 85 subjects
    • Data Provenance: The study was conducted in a hospital, indicating prospective data collection. The country of origin is not explicitly stated, but the company (Joytech Healthcare Co., Ltd.) is based in Hangzhou, China, suggesting the study likely took place in China.

    3. Number of Experts to Establish Ground Truth and Qualifications:

    • Number of Experts: Two doctors ("two doctors")
    • Qualifications: Not explicitly stated beyond "doctors." They performed "simultaneous and blinded blood pressure determinations," implying their expertise in taking manual blood pressure measurements.

    4. Adjudication Method for the Test Set:

    • The text states: "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies that the measurements from the two doctors served as the ground truth, but it doesn't describe a specific adjudication method (e.g., 2+1, 3+1). It is most likely a consensus or average, given the use of "averaged paired determinations" mentioned in Criterion B.

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

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focuses on the accuracy of the device against a reference standard, not its impact on human reader performance.

    6. Standalone Performance Study:

    • Yes, a standalone (algorithm only) performance study was conducted. The clinical validation directly assesses the device's accuracy in measuring blood pressure compared to a reference standard (mercury sphygmomanometer).

    7. Type of Ground Truth Used:

    • The ground truth used was expert consensus/reference standard measurement. Specifically, a "standard mercury sphygmomanometer was used as a reference standard," with readings taken by two doctors.

    8. Sample Size for the Training Set:

    • The document describes a clinical validation study for accuracy, not a training set for an AI/machine learning model. Therefore, a "training set" in the context of machine learning is not applicable to this device's validation. The device uses an "oscillometric method and silicon integrate pressure sensor technology," which is a traditional algorithm, not typically a deep learning AI requiring large training sets in the same way.

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

    • As mentioned above, a training set for an AI/machine learning model is not applicable here. The device functions based on an oscillometric algorithm, which relies on physical principles and pre-programmed logic, not a data-driven training process in the AI sense. Its accuracy is evaluated against established clinical validation standards.
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