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510(k) Data Aggregation

    K Number
    K151940
    Device Name
    Thora-3Di, Model T-01
    Manufacturer
    PneumaCare LIMITED
    Date Cleared
    2016-03-10

    (240 days)

    Product Code
    BZQ,BZO
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K090273
    Predicate For
    K242001
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thora-3Di is intended for a one-time measurement of respiratory rate as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

    The Thora-3Di is not intended to monitor vital signs. This device is not an apnea monitor.

    Device Description

    The Thora-3Di uses Structured Light Plethysmography (SLP) to derive respiratory rate. With the Thora-3Di, a structured grid pattern of light is projected onto the thoracoabdominal wall and two digital video cameras record changes in the grid pattern due to movement of the wall. A dedicated parallel processor executes real-time pattern recognition algorithms to identify the position of each part of the virtual grid in each camera. The system computes the 3-dimensional coordinates of the different markers to assess respiratory rate.

    The Thora-3Di does not include any wireless transmission features, nor does it include a cloud or other remote functionality (no cybersecurity-related features).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Mean Squared Difference (MSD) between Thora-3Di and Capnography (Clinician Overscored CO2) < 0.81 brpm (corresponding to limits of agreement of +/- 2 brpm)MSD = 0.136 brpm
    95% Limits of Agreement between Thora-3Di and Capnography (Clinician Overscored CO2)(-0.72, 0.75 brpm)

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

    • Sample Size: 35 adult subjects
    • Data Provenance: The study involved "healthy adults and adults with respiratory disease or impairment." The document does not explicitly state the country of origin, but given the manufacturer (PneumaCare Limited) is based in the United Kingdom, it's plausible the study was conducted there or in a related region. The study is described as a "clinical trial," which implies a prospective design.

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

    The ground truth for the clinical study was established using "COSC (Clinician Overscored CO2 derived from the reference capnograph device)." The document explicitly mentions "Clinician Overscored," indicating that clinicians were involved in evaluating the capnography data to establish the ground truth. However, the number of clinicians and their specific qualifications (e.g., years of experience, specialty) are not specified in the provided text.

    4. Adjudication Method for the Test Set

    The adjudication method is described as "Clinician Overscored CO2 derived from the reference capnograph device." This implies that clinicians reviewed and, presumably, validated or refined the CO2 measurements from the capnograph to establish the most accurate respiration rate. The exact process of adjudication (e.g., if multiple clinicians reviewed and resolved discrepancies, or if it was a single clinician oversight) is not detailed.

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

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compared the device's performance against a reference standard (capnography with clinician overscoring), not against human readers with and without AI assistance.

    6. Standalone Performance Study

    Yes, a standalone performance study was done. The clinical trial directly evaluated the Thora-3Di's respiratory rate measurements against a gold standard (capnography). The primary endpoint analysis was to compare the output respiratory rate of Thora-3Di with that of the COSC.

    7. Type of Ground Truth Used

    The type of ground truth used for the clinical study was "expert consensus" (clinician overscored) applied to "physiological measurement data" (Capnography).

    8. Sample Size for the Training Set

    The document does not specify a training set sample size. The description of the device as executing "real-time pattern recognition algorithms" suggests machine learning may be involved, requiring training data, but this information is not provided. The clinical study described appears to be a validation or test set rather than a training set.

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

    As no training set sample size is specified, the method for establishing its ground truth is also not provided in the document.

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