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510(k) Data Aggregation

    K Number
    K090863
    Device Name
    PERSONAL WHEEZOMETER
    Manufacturer
    KARMELSONIX
    Date Cleared
    2009-09-21

    (175 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K980878,k071955,K012387
    Why did this record match?
    Device Name :

    PERSONAL WHEEZOMETER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PERSONAL WHEEZOMETER™ is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.

    Device Description

    The PERSONAL WHEEZOMETER™ ™ is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of wheczes. The device outputs a wheezerate score based on the amount of wheezing detected in a given time. The PERSONAL WHEEZOMETER™ (PW) is intended to be a home use version of the PulmoTrack® (K980878) and PulmoTrack model 2010 (WIM-PC) (K071955), providing wheeze-rate information for both home and clinical settings.

    The PERSONAL WHEEZOMETER™ device consists of:

    • An acoustic contact sensor
    • An air-coupled electret microphone for ambient noise rejection module.
    • LCD screen to display measurement results
    • 4 user buttons
    • Signal conditioning and digitization PCB
    • Dedicated DSP
    • SDRAM memory
    • Embedded software.
    AI/ML Overview

    This 510(k) summary does not contain sufficient information to comprehensively answer all aspects of your request. Specifically, it lacks detailed quantitative acceptance criteria and the results of the performance study against those criteria, as well as specific information about ground truth establishment and training set details.

    Here's what can be extracted and what is missing:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Specific quantitative criteria for wheeze detection (e.g., sensitivity, specificity, accuracy, precision, F1-score) are not provided"All testing results demonstrated satisfactory performance."
    "The PERSONAL WHEEZOMETER™ meets its labeled performance claims..."
    Usability/Safety"The results of this usability study clearly indicate that the Personal Wheezometer is safe and effective when operated by intended users. In addition, it is easy to learn and operate the Personal Wheezometer while using the User Manual."
    Biocompatibility"Materials of the PERSONAL WHEEZOMETER™ device are biocompatible in accordance with ISO 10993-1."

    2. Sample size used for the test set and the data provenance

    • Test Set Sample Size: Not specified for the clinical study.
    • Data Provenance: The document states that KarmelSonix is an Israeli company and the contact person is from Israel. The clinical study was likely conducted in Israel, but this is not explicitly stated. The study is prospective, as it's a "clinical usability study" performed with the device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of Experts: Not specified.
    • Qualifications of Experts: Not specified. (It's unclear if experts were even used to establish ground truth for wheezing, as the study primarily focused on usability.)

    4. Adjudication method for the test set

    • Not specified. Given the focus on usability, a formal adjudication process for wheeze detection may not have been the primary objective.

    5. 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

    • A MRMC comparative effectiveness study was not conducted. The study described is a "clinical usability study" of the device itself, not a comparative study with human readers or AI assistance.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • The device, PERSONAL WHEEZOMETER™, is essentially a standalone algorithm for quantifying wheezing, displaying a "wheezerate score." The "clinical usability study" would inherently assess its standalone performance in a real-world user context. However, specific metrics of algorithm-only performance (e.g., sensitivity/specificity against a gold standard) are not detailed.

    7. The type of ground truth used

    • The document does not explicitly state the type of ground truth used for evaluating wheezing detection. Given the clinical usability study context, it's possible that clinical assessment by physicians (expert consensus) or correlation with other diagnostic tools might have been informally used, but this is not detailed.

    8. The sample size for the training set

    • Not specified. The document does not mention details about a training set, implying a pre-trained algorithm or an algorithm developed without a distinct "training set" in the context of this submission. The device is a home-use version of previously cleared devices (PulmoTrack® and PulmoTrack model 2010), so its core algorithms might have been developed and validated previously.

    9. How the ground truth for the training set was established

    • Not specified, as details about a training set are not provided.
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