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

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.

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.

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.

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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.

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").

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.

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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