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510(k) Data Aggregation

    K Number
    K070593
    Date Cleared
    2007-05-07

    (66 days)

    Product Code
    Regulation Number
    862.1345
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRACKRECORD DATA MANAGEMENT SOFTWARE

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

    TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification for a software device called "Track Record Data Management Software." It's a regulatory clearance from the FDA, not a scientific study report. Therefore, it does not contain the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for performance evaluation.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance is based on substantial equivalence to an existing device, not necessarily on a new performance study demonstrating the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.

    Therefore, I cannot provide the requested table and details because they are not present in the provided text.

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