LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991075
    Device Name
    ATLAST GLUCOSE CONTROL SOLUTION
    Manufacturer
    AMIRA MEDICAL, INC.
    Date Cleared
    1999-05-10

    (40 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K982076,K944459
    Why did this record match?
    Device Name :

    ATLAST GLUCOSE CONTROL SOLUTION

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

    For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.

    Device Description

    The AtLast Glucose Control Solution is an aqueous control. The control is intended to be used with the Atl.ast Blood Glucose System (AtLast System, K982076) for quality control purposes by the end-user (diabetic consumer). The AtLast System is an over-the-counter (OTC) combination blood sampler and glucose meter that provides blood glucose measurements on samples obtained from various body sites including the forearm, the upper arm, the thigh and the finger tip.

    AI/ML Overview

    This document describes the AtLast™ Control Solution, an aqueous glucose control solution intended for use with the AtLast Blood Glucose System for quality control purposes.

    Here's an analysis of the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state pre-defined acceptance criteria for the AtLast™ Control Solution. It only describes the study conducted and the conclusion drawn from it.

    Acceptance Criteria (Not Explicitly Stated)Reported Device Performance
    Presumably, sufficient precision across glucose levels to ensure accurate quality control and functionality of the AtLast Blood Glucose System."The data indicate good performance for all glucose levels." (Based on precision studies)

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

    • Sample Size for Test Set: Each level of glucose control was assayed:
      • with three AtLast systems.
      • in triplicate (3 measurements per system per level per day).
      • over 20 days.
      • This resulted in a total of 60 measurements per level, per meter (3 systems * 3 measurements/day/system * 20 days = 180 total measurements per level across the three systems, or 60 measurements per level for each individual meter).
    • Data Provenance: The document does not specify the country of origin of the data. It is a prospective study as it describes a specific experimental setup to generate data for evaluation.

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

    This section is not applicable as the device is a control solution for a glucose meter. Ground truth in this context would likely refer to the verified concentration of glucose in the control solution itself, which is inherently part of its manufacturing specification, rather than requiring expert interpretation of diagnostic images or clinical cases. The "ground truth" for the performance evaluation would be the expected glucose concentration of the control solution against which the meter readings were compared for precision.

    4. Adjudication Method for the Test Set

    This section is not applicable. As a control solution, there is no "adjudication" in the sense of reconciling differing expert opinions or classifications. The evaluation focuses on statistical precision and accuracy against a known target value.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The AtLast™ Control Solution is an in-vitro diagnostic control.

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

    The study described evaluates the performance of the AtLast Glucose Control solutions in conjunction with the AtLast Blood Glucose System. While the blood glucose meter itself has an "algorithm" to measure glucose, the study's focus is on the control solution's ability to demonstrate consistent results when used with the meter and test strips. It is not an evaluation of an artificial intelligence algorithm in a standalone capacity.

    7. The Type of Ground Truth Used

    The ground truth for evaluating the control solution's performance would be the assigned target value (known glucose concentration) of each level of the control solution. The study focused on the precision of the measurements obtained using the control solution with the AtLast system, which implicitly relies on the control having a known and stable glucose concentration.

    8. The Sample Size for the Training Set

    This section is not applicable. The AtLast™ Control Solution is a diagnostic control, not an AI/ML algorithm that requires a training set. The "data" mentioned in the document refers to performance evaluation data generated through laboratory testing, not data used to train a model.

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

    This section is not applicable for the same reasons as point 8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1