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510(k) Data Aggregation

    K Number
    K131048
    Manufacturer
    Date Cleared
    2013-08-28

    (135 days)

    Product Code
    Regulation Number
    870.1435
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIDCO CNAP MODULE

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

    The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals. The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor. The LiDCO CNAP Module supports the following parameters: Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial mean pressure Heart rate Locations of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Sultes Step Down / High Dependency Units Trauma / Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the LiDCO CNAP Module. It outlines the device's indications for use and regulatory classification but does not contain information about acceptance criteria or a study proving its performance.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
    6. If a standalone performance (algorithm only) study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    This document is a regulatory approval, not a technical performance report. To find the information you're looking for, you would typically need to consult the full 510(k) submission, scientific publications, or the manufacturer's technical documentation.

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