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    K Number
    K982076
    Device Name
    AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    AMIRA MEDICAL, INC.
    Date Cleared
    1998-12-10

    (181 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K922888,K923048
    Why did this record match?
    Reference Devices :

    K922888, K923048

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

    The ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children).

    The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

    Device Description

    The ATLAST Blood Glucose Monitoring System measures the amount of glucose in capillary whole blood. When whole blood is applied to the ATLAST Test Strip, reagents on the Test Strip react with the blood and a color is formed, the intensity of which is measured by the ATLAST System. The ATLAST Blood Glucose Monitoring System consists of the following components: (1) a reflectance photometer which incorporates a lancing device ("ATLAST System"), (2) glucose reagent test strips ("ATLAST Test Strips") and calibration chip, and (3) sterile lancets ("ATLAST Lancets").

    AI/ML Overview

    The Amira Medical ATLAST Blood Glucose Monitoring System is a medical device intended for the quantitative measurement of glucose in whole blood for individuals with diabetes mellitus.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The provided document does not explicitly state specific numerical acceptance criteria (e.g., specific percentages within a certain glucose range based on an error grid). However, it outlines the general approach to evaluating performance and states that the device met these requirements.

    Acceptance Criteria (Inferred from text)Reported Device Performance
    Meets or exceeds performance requirements for intended clinical use."The System meets or exceeds the performance requirements for the intended clinical use of the device."
    Satisfies all performance specifications for safety and effectiveness."The results demonstrated that the ATLAST Blood Glucose Monitoring System satisfies all of its performance specifications, which are designed to ensure that the System is safe and effective for its intended use."
    Correlates well with laboratory blood glucose reference test method."The clinical data demonstrate that the performance of the ATLAST Blood Glucose Monitoring System correlates well with the laboratory blood glucose reference test method."
    Provides results within the range of clinically acceptable accuracy (based on Error Grid Analysis)."When the blood glucose test results were analyzed by the Error Grid Analysis of Clarke et al., the System provided results within the range of clinically acceptable accuracy."
    Substantially equivalent to a predicate device."The data also demonstrate that the ATLAST Blood Glucose Monitoring System's performance is substantially equivalent to that of a predicate device."
    Performs equivalently in the hands of diabetic lay users and trained technicians."The clinical data demonstrate that the ATLAST Blood Glucose Monitoring System performs equivalently in the hands of the diabetic lay user and when used by a trained technician."

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

    • Sample Size: The document does not specify the exact sample size for the "multi-center, subject controlled clinical study."
    • Data Provenance: The data was collected through a "multi-center, subject controlled clinical study." This indicates a prospective study where participants were actively recruited and data was collected specifically for the study. The country of origin is not explicitly stated, but the submission is to the US FDA, implying US-based or internationally recognized standards.

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

    • The document implies that a "laboratory reference method for measuring blood glucose levels" was used to establish ground truth.
    • It does not specify the number of experts or their qualifications for performing this reference method. It can be inferred that these would be licensed clinical laboratory professionals following standard laboratory procedures.

    4. Adjudication Method for the Test Set:

    • No explicit adjudication method is mentioned for reconciling discrepancies in the ground truth. The ground truth was established by a "laboratory reference method," which typically implies a single, highly accurate measurement serving as the definitive value.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

    • This device is a blood glucose monitoring system, not an imaging or diagnostic device that requires human "readers" or AI assistance in interpretation in the typical sense of an MRMC study.
    • The study compared the device's performance when used by lay users (diabetic patients) versus trained technicians. This is a comparison of user groups rather than a human-AI comparison.
    • Therefore, an MRMC comparative effectiveness study in the context of human readers improving with AI vs. without AI assistance was not applicable and not performed.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

    • The device is a standalone system. The "ATLAST System" measures glucose, and the results are directly displayed to the user.
    • Bench/Laboratory testing was performed to evaluate the system in isolation, and the clinical study evaluated the system's performance both by lay users and trained technicians.
    • While human interaction is required to obtain the blood sample and initiate the test, the measurement and calculation of glucose levels are performed solely by the device's internal algorithms. Therefore, a standalone performance evaluation of the "algorithm only" (as part of the finished device) was inherently performed.

    7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

    • The ground truth for the test set was established using a laboratory reference method for measuring blood glucose levels. This is considered a highly accurate and objective measure in clinical chemistry.

    8. The Sample Size for the Training Set:

    • The document does not provide information about a separate "training set" or its sample size. The description focuses on the performance testing carried out on the finished device. For a device like a blood glucose meter, the "training" (calibration) is typically done during the device's manufacturing and validation process, often using standardized solutions and internal quality control, not a separate clinical training set in the way AI algorithms are trained.

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

    • Since a separate "training set" as understood in AI/machine learning is not explicitly mentioned, the method for establishing its ground truth is also not described. Device calibration and internal validation would rely on established laboratory standards and methods for glucose concentration.
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