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The Gmate® mini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh or calf. The Gmate® mini Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.

The Gmate® mini Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gnate® mini Blood Glucose Monitoring System is NOT intended for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).

The Gmate® Blood Glucose Test Strips are for use with the Gmate® mini Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.

The Gmate® STEP Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® STEP Blood Glucose Monitoring System is intended to be used by a single person and should not be shared with any other person.

The Gmate® STEP Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gnate® STEP Blood Glucose Monitoring System is NOT intended for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).

The Gmate® STEP includes a pedometer feature that allows the user to count the number of steps they take.

The Gmate® Blood Glucose Test Strips are for use with the Gmate® STEP Blood Glucose Monitoring System only for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.

The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® mini Blood Glucose Monitoring System and the Gmate® STEP Blood Glucose Monitoring System are intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current, calculates your blood glucose level, and displays your blood glucose test result.

The provided text describes the Gmate® mini Blood Glucose Monitoring System and Gmate® STEP Blood Glucose Monitoring System, their intended use, and substantial equivalence to a predicate device. It also briefly mentions that non-clinical and clinical tests were performed to establish performance, functionality, and reliability. However, the document does not contain specific acceptance criteria, reported device performance metrics (like sensitivity, specificity, accuracy percentages, etc.), sample sizes for test or training sets, data provenance, details about experts or adjudication methods, or results of MRMC studies. The text only states that the devices "met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide numerical details for most of your questions based solely on the provided text.

Here's what can be inferred or stated based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 100 persons with diabetes and healthcare professionals (for the clinical performance evaluation testing).
• Data Provenance: Not explicitly stated, but clinical testing was conducted "at a clinic center." The manufacturer is based in the Republic of Korea. It's unclear if the study was retrospective or prospective, but the description of clinical performance evaluation suggests a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The clinical performance evaluation involved "healthcare professionals at a clinic center," but their specific role in establishing ground truth (e.g., as experts) is not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, this device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study involving human readers improving with AI is not applicable nor mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, the device underwent "system accuracy," "precision," "linearity," "interference," "hematocrit," "altitude," and "temperature/humidity" testing, which are standalone algorithm/device performance evaluations without human intervention in the measurement process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for the clinical performance evaluation was established by comparing the device's results to those obtained using the YSI 2300 Glucose Analyzer, a laboratory instrument. This is considered a highly accurate laboratory reference method for glucose measurement.

8. The sample size for the training set:

• Not specified. The document describes performance evaluation (testing), but does not detail a separate training set for algorithm development.

9. How the ground truth for the training set was established:

• Not specified, as no training set details are provided.

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