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510(k) Data Aggregation

    K Number
    K031514
    Device Name
    MODIFICATION TO TRUPEAK PEAK FLOW METER
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Date Cleared
    2003-05-23

    (9 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

    Device Description

    The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for the TRUPEAK Peak Flow Meter. It is a regulatory approval document from the FDA and does not contain the detailed study information or acceptance criteria requested in the prompt.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance data, study design, or ground truth establishment.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: This information is not present.
    2. Sample size used for the test set and the data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
    6. If a standalone study was done: Not mentioned.
    7. The type of ground truth used: Not mentioned.
    8. The sample size for the training set: Not mentioned (as this is a medical device, not an AI/ML model, training sets are not typically applicable in the same way).
    9. How the ground truth for the training set was established: Not mentioned.
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