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510(k) Data Aggregation

    K Number
    K193371

    Validate with FDA (Live)

    Device Name
    FreeStyle Libre 2 Flash Glucose Monitoring System
    Manufacturer
    Abbott Diabetes Care Inc.
    Date Cleared
    2020-06-12

    (190 days)

    Product Code
    QLG,NBW
    Regulation Number
    862.1355
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    K171941,DEN170088
    Predicate For
    K201761,K202145,K211102
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

    The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

    The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

    Device Description

    The FreeStyle Libre 2 Flash Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 2 System or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. The FreeStyle Libre 2 System consists of two primary components: a sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User-initiated RFID scanning provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may use the sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alerts and alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the studies conducted for the FreeStyle Libre 2 Flash Glucose Monitoring System, based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance Criteria CategorySpecific Criteria/MetricReported Device Performance (Adult)Reported Device Performance (Pediatric 6-17)Reported Device Performance (Pediatric 4-5)
    Accuracy (Overall)Percent of iCGM values within 20% of YSI reference90.2% (95% LCL: 88.7%)90.3% (95% LCL: 88.1%)85.4% (95% LCL: 80.3%) (SMBG as comparator)
    Accuracy (Point/Percent, iCGM Range < 70 mg/dL / <54 mg/dL / 54-69 mg/dL)% within 15 mg/dL89.0% (<70mg/dL), 85.9% (<54mg/dL), 89.5% (54-69mg/dL)82.7% (<70mg/dL), 71.9% (<54mg/dL), 86.4% (54-69mg/dL)N/A (SMBG used for 4-5)
    Accuracy (Point/Percent, iCGM Range 70-180 mg/dL / 181-250 mg/dL / >250 mg/dL)% within 15%75.9% (70-180mg/dL), 89.1% (181-250mg/dL), 94.0% (>250mg/dL)78.0% (70-180mg/dL), 86.0% (181-250mg/dL), 92.2% (>250mg/dL)N/A (SMBG used for 4-5)
    Accuracy (Point/Percent, YSI Range < 70 mg/dL / <54 mg/dL / 54-69 mg/dL)% within 15 mg/dL95.3% (<70mg/dL), 91.1% (<54mg/dL), 94.7% (54-69mg/dL)94.9% (<70mg/dL), 93.9% (<54mg/dL), 96.5% (54-69mg/dL)N/A (SMBG used for 4-5)
    Accuracy (Point/Percent, YSI Range 70-180 mg/dL / 181-250 mg/dL / >250 mg/dL)% within 15%76.5% (70-180mg/dL), 87.9% (181-250mg/dL), 90.9% (>250mg/dL)74.3% (70-180mg/dL), 86.6% (181-250mg/dL), 90.2% (>250mg/dL)N/A (SMBG used for 4-5)
    PrecisionMean Coefficient of Variation (Mean %CV)5.7%5.8%4.8%
    Low Glucose Alarm (e.g., 70 mg/dL)True Alarm Rate86.0%80.3%N/A
    False Alarm Rate14.0%19.7%N/A
    Correct Detection Rate89.3%93.5%N/A
    Missed Detection Rate10.7%6.5%N/A
    High Glucose Alarm (e.g., 200 mg/dL)True Alarm Rate99.2%98.0%N/A
    False Alarm Rate0.8%2.0%N/A
    Correct Detection Rate97.1%98.0%N/A
    Missed Detection Rate2.9%2.0%N/A
    Sensor Stability (MARD)Mean Absolute Relative Difference (MARD) throughout wear duration9.9% (Beginning), 8.5% (Early Middle), 8.8% (Late Middle), 9.1% (End)10.7% (Beginning), 8.0% (Early Middle), 9.7% (Late Middle), 10.2% (End)N/A
    Sensor LifeSurvival Rate by Day 1471.1%78.1%N/A
    Glucose Reading AvailabilityCapture Rate over wear durationRanges from 98.1% to 98.6%Ranges from 94.6% to 96.0%N/A
    Reportable Range40 to 400 mg/dLSupported by clinical study data (display 'LO' or 'HI' outside range)Supported by clinical study data (display 'LO' or 'HI' outside range)Supported by clinical study data (display 'LO' or 'HI' outside range)
    Ascorbic Acid InterferenceMax average sensor bias after 3x1000mg dosesLess than 20 mg/dL (after second and third 1000mg doses)Not explicitly stratified by age for this study, assumed adults.N/A

    Study Information

    1. Sample Size and Data Provenance:

      • Clinical Accuracy Studies (Study 1 & Study 2):
        • Study 1 (Adults): 146 subjects (91.1% Type 1, 8.9% Type 2 diabetes, all requiring insulin).
        • Study 2 (Pediatric): 139 subjects (98.6% Type 1, 1.4% Type 2 diabetes, all requiring insulin).
        • Age Groups in Study 2 (for YSI comparison): 77 pediatric subjects for <70 mg/dL range, 124 for 70-180 mg/dL and >180 mg/dL range. Specific breakdown for 4-5 and 6-17 years where YSI was used.
        • Age Groups in Study 2 (for SMBG comparison): 8 pediatric subjects (4-5 years old) only had SMBG as comparator.
        • Data Provenance: Prospective, multi-center studies conducted at five (adult) and four (pediatric) centers in the United States.
      • Ascorbic Acid Interference Study: 60 subjects (adults, age 18 and older) with diabetes, across 4 sites.
      • Precision Study (from Clinical Studies):
        • Adults (18+): 146 subjects, 26,791 paired readings.
        • Pediatric 4-5 years: 7 subjects, 248 paired readings.
        • Pediatric 6-17 years: 130 subjects, 10,623 paired readings.

    2. Number of Experts and Qualifications for Ground Truth:

      • The document implies that the ground truth for glucose values was established using a "laboratory glucose reference" (YSI) analyzer. While YSI analyzers are highly accurate, the document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It refers to the YSI as the comparator method, which is a laboratory instrument, not human experts. For pediatric subjects aged 4-5 years, Self-Monitoring Blood Glucose (SMBG) tests were used as the comparator method.

    3. Adjudication Method for the Test Set:

      • Not applicable in the traditional sense of medical image adjudication. The "ground truth" was established by a laboratory reference method (YSI for most cases, SMBG for some pediatric cases). There's no indication of an adjudication process involving multiple human readers to resolve discrepancies in ground truth measurements. The comparison is between the device and the reference instrument.

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

      • No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. The FreeStyle Libre 2 is a standalone diagnostic device that measures glucose directly, so its performance is compared against a reference standard (YSI, SMBG), not human interpretation with or without AI.

    5. Standalone (Algorithm Only) Performance:

      • Yes, the studies primarily assessed standalone performance. The device automatically provides continuous glucose measurements. The "iCGM glucose values" are the output of the algorithm. The intent is for the device to replace blood glucose testing for treatment decisions, which is a standalone use case. Human interpretation of trends and patterns is part of the overall management, but the device's accuracy itself is assessed in a standalone manner against the reference.

    6. Type of Ground Truth Used:

      • Laboratory Reference and Self-Monitoring Blood Glucose (SMBG):
        • For adult subjects and pediatric subjects aged 6-17 years, the primary ground truth was established by YSI glucose measurements. YSI (Yellow Springs Instrument) is a common laboratory method considered a highly accurate reference for glucose.
        • For pediatric subjects aged 4-5 years, the ground truth was established by SMBG (Self-Monitoring Blood Glucose) tests.

    7. Sample Size for the Training Set:

      • The document mentions "clinical evaluation" and "pivotal clinical studies" but does not explicitly state the sample size of a training set specifically for algorithm development or machine learning. The provided clinical studies (Study 1 and Study 2) describe the test sets used for performance evaluation, not necessarily for training the algorithm. CGM devices typically use complex calibration algorithms developed with extensive internal data that is not always detailed in 510(k) summaries.

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

      • As the document does not provide details on a specific training set or its size, it also does not elaborate on how the ground truth for such a set was established. We can infer that similar high-accuracy laboratory reference methods (like YSI) would have been used during the development and calibration phases of the device, prior to the validation studies described in the submission.
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