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510(k) Data Aggregation

    K Number
    K081715

    Validate with FDA (Live)

    Device Name
    FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2008-12-17

    (182 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FORA TD-4244 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

    The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

    The FORA TD-4244 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

    Device Description

    Not Found

    AI/ML Overview

    The FDA 510(k) summary for the FORA TD-4244 Blood Glucose Monitoring System (K081715) provides some information about device performance but does not include a detailed study description with all the requested elements. However, I can extract the available information to construct a response.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document refers to the ISO 15197:2003 standard, which defines accuracy criteria for blood glucose monitoring systems.

    Acceptance Criteria (ISO 15197:2003)Reported Device Performance (FORA TD-4244)
    For Glucose Concentrations < 75 mg/dL (4.2 mmol/L): Minimum 95% of results must be within ± 15 mg/dL (0.83 mmol/L) of the reference method.For glucose concentration < 75 mg/dL: 98.2% of results were within ± 15 mg/dL.
    For Glucose Concentrations ≥ 75 mg/dL (4.2 mmol/L): Minimum 95% of results must be within ± 20% of the reference method.For glucose concentration ≥ 75 mg/dL: 98.0% of results were within ± 20%.
    Combined Accuracy: Minimum 95% of results must meet the respective criteria (both < 75 mg/dL and ≥ 75 mg/dL).98.1% of results met the criteria, satisfying the requirement to have at least 95% of results within the specified accuracy ranges for both categories.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size for Test Set: 100 participants.
    • Data Provenance: The document states "Clinical study results: The study was performed by collecting fingerstick blood samples from 100 participants." This implies a prospective clinical study. The country of origin for the data is not explicitly mentioned but can be inferred to be China (Taiwan) based on the manufacturer's address.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

    • This information is not provided in the given document. For blood glucose meters, the "ground truth" (reference method) is typically established by laboratory-grade analyzers, not human experts in the traditional sense.

    4. Adjudication Method for the Test Set:

    • This information is not applicable as the ground truth is established by a reference method, not by expert consensus requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human-Reader Improvement with AI vs. without AI Assistance:

    • This information is not applicable as the device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would involve human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    • Yes, the performance data presented is for the standalone device (FORA TD-4244 Blood Glucose Monitoring System) against a reference laboratory method. Human intervention is limited to sample collection and device operation, not interpretation of an algorithm's output.

    7. The Type of Ground Truth Used:

    • The ground truth was established using a reference laboratory method. The specific name of the reference method is not explicitly stated in the provided text, but for glucose monitoring systems, a common reference is a YSI 2300 STAT Plus Glucose & Lactate Analyzer or similar laboratory photometric methods.

    8. The Sample Size for the Training Set:

    • This information is not provided. Blood glucose meters are typically calibrated during manufacturing, and a "training set" in the context of machine learning is not directly applicable to traditional medical devices like this. The ISO 15197 study describes a validation study, not a training process.

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

    • This information is not provided and is generally not applicable in the context of device calibration versus machine learning model training.
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