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The GLUCOCARD 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

The ReliOn Micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

The GLUCOCARD 01-mini Blood Glucose Monitoring System and ReliOn Micro Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.

This document describes the 510(k) premarket notification for the GLUCOCARD 01-mini Blood Glucose Monitoring System and the ReliOn Micro Blood Glucose Monitoring System, which are intended for quantitative measurement of glucose in fresh capillary whole blood samples.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state the quantitative acceptance criteria for system accuracy in a table format, nor does it provide detailed numerical results of the device's performance against such criteria. It generally states that a "clinical study was done with persons with diabetes to evaluate system accuracy."

However, glucose monitoring systems like this are typically evaluated against standards like ISO 15197 for accuracy. A common acceptance criterion for blood glucose meters, as per ISO 15197, often includes:

• 95% of results falling within ±15 mg/dL of the reference method for glucose concentrations < 100 mg/dL.
• 95% of results falling within ±15% of the reference method for glucose concentrations ≥ 100 mg/dL.

Without the full study report, specific reported performance values against these criteria are not available in this document.

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

• Sample Size: The document mentions "A clinical study was done with persons with diabetes to evaluate system accuracy and to assess ease of use." However, it does not specify the sample size for this clinical study.
• Data Provenance: The document states that the clinical study was conducted with "persons with diabetes," implying real-world data collection. It doesn't specify the country of origin, but the submitting company is ARKRAY Factory, Inc. from Japan, with a US contact. It also doesn't explicitly state if the study was retrospective or prospective, but clinical studies for device accuracy are typically prospective.

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

The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the test set. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., an automated analyzer calibrated to a recognized standard) rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

As the ground truth is established by a laboratory reference instrument, there isn't typically an "adjudication method" in the sense of expert review or consensus for the test set results directly. The device's readings are compared against the reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for medical imaging or diagnostic interpretation tasks where human readers evaluate cases, often with and without AI assistance, to measure the impact of the AI on reader performance. For a blood glucose monitoring system, the device directly outputs a quantitative measurement, and human "readers" are not involved in interpreting the results in a diagnostic imaging sense.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the system accuracy evaluation is inherently a standalone performance study. The GLUCOCARD 01-mini and ReliOn Micro Blood Glucose Monitoring Systems are intended to provide a quantitative glucose measurement directly. The clinical study mentioned evaluates the system's ability to accurately measure glucose without human interpretation influencing the measurement itself. The "human-in-the-loop" aspect for a blood glucose meter primarily involves the user performing the test correctly and interpreting their own results, not in aiding the device's measurement.

7. Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method that is highly accurate and traceable to an international standard. While not explicitly stated in this summary, it is standard practice for glucose meter validation to compare the device's readings against a clinical laboratory analyzer.

8. Sample Size for the Training Set

The document does not provide any information about a "training set." This device is a blood glucose meter, not an AI/machine learning algorithm that requires a training set in the typical sense for image recognition or predictive modeling. The device's performance is determined by its electrochemical measurement technology, calibration, and manufacturing consistently.

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

Since there is no "training set" in the context of an AI/machine learning model for this medical device, there is no ground truth established for a training set. The device itself is calibrated during manufacturing to known glucose concentrations using reference methods.

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