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510(k) Data Aggregation

    K Number
    K130657
    Device Name
    LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE
    Manufacturer
    ALL MEDICUS CO., LTD
    Date Cleared
    2013-07-15

    (125 days)

    Product Code
    NBW,JQP
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K050985,K082328,K083628,k984527
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K050985,K082328,K083628

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

    The LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the GlucoDr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter.

    Device Description

    The LinkDr 2.0 Diabetes Management Software is optional data management software for use with All Medicus brand blood glucose meters: GlucoDr Supersensor(K050985), GlucoDr Plus(K082328), and GlucoDr auto(K083628). The subject device consists of a LinkDr USB cable and software (provided in a CD). The LinkDr 2.0 Diabetes Management Software allows the transfer of data from the mentioned blood glucose meters to a personal computer (PC) for enhanced data management using graphic displays and analysis tools.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the LinkDr 2.0 Diabetes Management Software, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    Acceptance Criteria RequirementReported Device Performance
    Data Accuracy TransmissionBench Testing: All glucose values, flags (control solution, post-meal, pre-meal, exercise, stress), date, and time properly downloaded from the meters to the software.
    Memory Data RolloverBench Testing: Memory data rollover functioned properly, with new glucose values replacing the oldest glucose values in meters that were pre-loaded with full memory (tested by adding 5 data points).
    User Ease of UseUser Study: 100% of personal lay users and professional healthcare users rated the LinkDr 2.0 Diabetes Management Software as "easy or somewhat easy" for overall program setup and use. No users rated it as "somewhat difficult or difficult."
    User SatisfactionUser Study: 100% of personal lay users and professional healthcare users reported satisfaction with the LinkDr 2.0 Diabetes Management Software and its manual.
    Data IntegrityStated Feature: Data transferred from the meter cannot be changed or modified in any way. (This is a design feature common to both the subject and predicate devices, confirmed by the general statement: "data transferred from the meter cannot be changed or modified in any way" when comparing to the predicate). Although not explicitly a "test result" in the performance section, it's a critical assurance for data management software. The performance tests regarding data accuracy transmission implicitly confirm this by verifying proper download of values, flags, date, and time, indicating data wasn't altered during transfer.

    Study Details

    1. Sample Size and Data Provenance (Test Set):

      • Data Accuracy Transmission & Memory Rollover: The exact numerical sample size for "bench testing" is not specified but it involved testing with "each meter" (GlucoDr Supersensor, GlucoDr Plus, and GlucoDr auto). The data provenance is not explicitly stated in terms of country of origin but implies laboratory/bench testing conducted by All Medicus Co., Ltd. The data is prospective as it describes tests conducted specifically for this submission.
      • User Study: The sample size for the user study (personal lay users and professional healthcare users) is not specified. The provenance is not explicitly stated, but it would have been conducted by All Medicus Co, Ltd., likely in their local region (Republic of Korea). The data is prospective.

    2. Number of Experts and Qualifications (Ground Truth for Test Set):

      • For Data Accuracy Transmission & Memory Rollover: No external experts are mentioned. The ground truth would have been based on the expected values directly from the blood glucose meters and the known behavior of memory rollover, assessed by the company's internal testing personnel.
      • For User Study: No external experts are mentioned for establishing ground truth for the "ease of use" and "satisfaction" metrics. The ground truth was based on the direct responses and ratings of the study participants themselves, acting as the subjective "ground truth" for their own experience.

    3. Adjudication Method (Test Set):

      • For Data Accuracy Transmission & Memory Rollover: No adjudication method is described. Bench testing typically involves direct comparison of transferred data against source data or expected system behavior, likely with pass/fail criteria.
      • For User Study: No adjudication method is described. User feedback was collected directly.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No MRMC comparative effectiveness study was done. This device is a data management software, not an AI diagnostic tool where human reader performance with/without AI assistance would be relevant.

    5. Standalone (Algorithm Only) Performance Study:

      • Yes, the performance data presented (data accuracy transmission, memory rollover) pertains to the standalone performance of the software and its interaction with the meters, demonstrating its functionality without direct human interpretation of the output data for diagnostic purposes (though humans interact with the software interface). The user study also assesses the standalone user experience.

    6. Type of Ground Truth Used:

      • For Data Accuracy Transmission & Memory Rollover: The ground truth was based on the objective data values and flags directly from the compatible blood glucose meters and the designed functionality of memory management.
      • For User Study: The ground truth was subjective user feedback and ratings (ease of use, satisfaction).

    7. Sample Size for the Training Set:

      • This document does not describe the use of machine learning or AI algorithms with "training sets" in the conventional sense. The software functions as a data transfer and display tool, not a predictive or interpretive algorithm that requires a training set. Therefore, no training set sample size is mentioned.

    8. How Ground Truth for the Training Set Was Established:

      • Not applicable, as no training set (for machine learning) is relevant to the description of this device. The software's development would have been based on specifications and requirements for data handling and user interface, rather than a labeled training dataset.
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