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510(k) Data Aggregation

    K Number
    K102823
    Device Name
    DISPOSABLE BLOOD PRESSURE CUFF
    Manufacturer
    WUXI MEDICAL INSTRUMENT FACTORY
    Date Cleared
    2011-01-07

    (100 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.

    Device Description

    The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study for a Disposable Blood Pressure Cuff.

    Here's the information extracted and organized:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    BiocompatibilityTested per ISO 10993 series standards.
    PerformanceTested per AAMI SP10:2002+A1:2003+A2:2006.
    Substantial EquivalenceFound to be substantially equivalent (SE) to predicate devices.

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

    The document does not explicitly state a specific sample size for a "test set" in the context of an algorithm or AI. Instead, it refers to standards for evaluating biocompatibility and performance of a physical device.

    • Test Set Sample Size: Not explicitly stated for specific human subjects or data points, but implies adherence to the sample size requirements of ISO 10993 and AAMI SP10 for device testing.
    • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is Wuxi Medical Instruments Factory in China.

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

    Not applicable. This is not an AI or algorithm-based device that would require expert-established ground truth for a test set. The "ground truth" for this device relates to its physical performance and biocompatibility according to established medical device standards.

    4. Adjudication Method for the Test Set

    Not applicable. This is not an AI or algorithm-based device that would require an adjudication method for a test set.

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

    No. This is a physical medical device (blood pressure cuff), not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    No. This is a physical medical device (blood pressure cuff). The concept of "standalone performance" for an algorithm is not applicable. The device's performance is tested according to AAMI SP10, which evaluates the physical function of the cuff.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance is established by adherence to recognized international standards:

    • Biocompatibility: ISO 10993 series standards.
    • Performance: AAMI SP10:2002+A1:2003+A2:2006.
    • Substantial Equivalence: Comparison to legally marketed predicate devices.

    8. The Sample Size for the Training Set

    Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

    Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.

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