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    K Number
    K132929
    Device Name
    SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    SD BIOSENSOR, INC.
    Date Cleared
    2015-08-05

    (687 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K100398
    Predicate For
    K153201
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

    The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

    SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.

    The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.

    SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

    Device Description

    SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology.

    SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes:

    • SD GlucoNavii® Mentor NFC Blood Glucose Meter
    • SD GlucoNavii® Mentor NFC Blood Glucose Test Strips
    • SD Glucose Check Strip
    • SD Glucose Control Solution - Level M
    • 3V Battery Type CR2032
    • User Instruction Guide
    • Quick Guide
    • Test Strip Package Insert
    • Control Solution Package Insert
    • Carrying Case
    • Lancing Device, Lancet

    SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes:

    • SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter
    • SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips
    • SD Glucose Check Strip
    • SD Glucose Control Solution Level M
    • 3V Battery Type CR2032
    • User Instruction Guide
    • Quick Guide
    • Test Strip Package Insert
    • Control Solution Package Insert
    • Carrying Case

    Optional software accessory

    • GlucoNavii® DMS
    • GlucoNavii®

    A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.

    The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

    AI/ML Overview

    The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format usually expected for complex medical imaging devices or AI-driven diagnostic tools. This submission is for a Blood Glucose Monitoring System, which falls under a different regulatory pathway.

    However, based on the non-clinical and clinical tests performed, I can extract information related to "System Accuracy" and "User Performance Studies" as the closest equivalent to acceptance criteria and the studies performed.

    Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document mentions that "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." ISO 15197 is an international standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus. It defines minimum requirements for system accuracy.

    While the exact numerical acceptance criteria from ISO 15197 are not explicitly listed in the document, it's a common standard for blood glucose meters. The document states that "The study results support that SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalence to other predicate devices in the market" and that the testing "met all relevant standards requirements." This implies compliance with ISO 15197.

    Based on typical ISO 15197:2013 (or earlier versions like 2003, which might have been relevant in 2015) standards for system accuracy:

    Acceptance Criteria (Typical ISO 15197)Reported Device Performance (Implied)
    For glucose concentrations < 100 mg/dL (5.55 mmol/L): Minimum 95% of results shall fall within ±15 mg/dL (±0.83 mmol/L) of the reference method.The document states, "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." It also concludes that "testing met all relevant standards requirements." This implies that the device achieved at least 95% of results within ±15 mg/dL of the reference method for glucose concentrations below 100 mg/dL, in accordance with ISO 15197.
    For glucose concentrations ≥ 100 mg/dL (5.55 mmol/L): Minimum 95% of results shall fall within ±15% of the reference method.Similarly, for glucose concentrations at or above 100 mg/dL, the device is implied to have achieved at least 95% of results within ±15% of the reference method, as required by ISO 15197.
    For the combined range: 99% of all individual glucose measurement results shall fall within zone A and B of the Consensus Error Grid.The document does not explicitly state CEG results, but compliance with ISO 15197 likely indicates adherence to this aspect as well, where 99% of results would fall within clinically acceptable ranges (Zone A and B) on the Consensus Error Grid. The statement "User performance studies were performed to demonstrate that lay consumers could obtain accurate results using the SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems" further supports the device's ability to produce clinically relevant and safe results when used by target users.

    2. Sample size used for the test set and the data provenance

    The document does not specify the exact sample size for the system accuracy or user performance studies. It only mentions that "System accuracy evaluations... were performed according to ISO 15197" and "User performance studies were performed."

    • Sample Size: Not specified in the provided text.
    • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Studies for regulatory submissions are typically prospective clinical studies.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    The concept of "experts establishing ground truth" is not directly applicable in the same way for a blood glucose monitoring system as it would be for diagnostic imaging or AI.

    For blood glucose meters, the "ground truth" (reference method) is typically established by a central laboratory reference method (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar) which is regularly calibrated and precisely measures glucose concentrations in blood samples. These reference methods are highly accurate and do not rely on a panel of human experts for interpretation.

    • Number of experts: Not applicable in the context of ground truth for a blood glucose meter. The ground truth is established by a validated laboratory reference instrument.
    • Qualifications of those experts: Not applicable.

    4. Adjudication method for the test set

    Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies in their interpretations to establish a final ground truth. This is not applicable to blood glucose measurement system accuracy where the reference method provides a definitive numerical value.

    • Adjudication method: Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    MRMC studies and the concept of "human readers improve with AI vs without AI assistance" are relevant for AI-driven diagnostic tools that augment human interpretation, such as in radiology or pathology. This is not applicable to a standalone blood glucose monitoring system, which provides a numerical measurement directly to the user.

    • MRMC study: Not applicable.
    • Effect size of human reader improvement with/without AI: Not applicable.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    A blood glucose monitoring system, by its nature, is a standalone device in terms of its measurement algorithm. The device measures glucose and displays a result. There isn't typically a "human-in-the-loop" influencing the measurement itself, beyond proper sample application and adherence to instructions. The "System Accuracy" and "User Performance" studies evaluate the device's standalone performance (its algorithm and hardware together) and its performance when used by a lay user, respectively.

    • Standalone performance: Yes, the "System Accuracy" assessment is essentially a standalone performance evaluation against a reference method. The "User Performance Studies" validate that lay users can obtain accurate results, implying the device's performance is robust even with typical user interaction.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The ground truth for blood glucose monitoring systems is established using a laboratory reference method (e.g., a highly accurate and calibrated glucose analyzer like a YSI instrument). This is considered the gold standard for glucose measurement in such studies.

    • Type of ground truth: Laboratory reference method.

    8. The sample size for the training set

    The concept of a "training set" and "testing set" is primarily relevant for machine learning or AI models. While the device likely undergoes extensive internal calibration and development (which could be considered analogous to "training"), the document does not refer to a distinct "training set" in the context of an AI algorithm. For a traditional electrochemical biosensor, the "training" involves optimizing the design, chemical reagents, and electronics using a range of known glucose concentrations during development.

    • Sample size for the training set: Not specified, and likely not applicable in the AI/ML sense.

    9. How the ground truth for the training set was established

    As above, the concept of a "training set ground truth" is not directly applicable to this type of device in the same way as AI. The "ground truth" during development and calibration would be established using glucose solutions or blood samples with precisely known glucose concentrations determined by highly accurate laboratory reference methods.

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