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The Gmate® SMART Blood Glucose Monitoring System is intended 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® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of 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® SMART Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.

The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.

The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART 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 Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone iack of the Apple device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4tt generation, iPad, and iPad2), to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook 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 and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple device.

Acceptance Criteria and Study for Gmate® SMART Blood Glucose Monitoring System

This document describes the acceptance criteria and the study performed for the Gmate® SMART Blood Glucose Monitoring System, based on the provided 510(k) summary (K131230).

1. Acceptance Criteria and Reported Device Performance

The provided document states that the performance evaluations were conducted to establish the performance, functionality, and reliability characteristics of the Gmate® SMART Blood Glucose System, and "The devices passed all of the tests based on pre-determined Pass/Fail Criteria." However, the specific quantitative acceptance criteria (e.g., specific accuracy percentages for different glucose ranges) are not explicitly detailed in the provided text. It refers to compliance with ISO15197 and other reference standards, which would define these criteria.

Based on the general requirements of ISO 15197, for a blood glucose monitoring system, the acceptance criteria typically specify the percentage of results that must fall within certain accuracy ranges when compared to a laboratory reference method. A common set of criteria from ISO 15197:2003 (which was likely relevant in 2013/2014) is:

• For glucose concentrations < 75 mg/dL (4.2 mmol/L): at least 95% of the measured glucose values shall fall within ± 15 mg/dL (± 0.83 mmol/L) of the reference method values.
• For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): at least 95% of the measured glucose values shall fall within ± 20% of the reference method values.

Since the document states the device "passed all of the tests based on pre-determined Pass/Fail Criteria" and was performed in accordance with ISO15197, we infer that the device performance met the criteria of ISO15197. Without the exact quantitative data presented in the summary, we cannot create a detailed table of reported performance against specific numerical acceptance criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from the provided text. The document only broadly states that the device met the pre-determined Pass/Fail Criteria based on ISO15197.

2. Sample Size and Data Provenance for the Test Set

The 510(k) summary does not specify the exact sample size used for the clinical test set, nor does it explicitly state the country of origin or whether the study was retrospective or prospective. It generally refers to "Non-clinical and clinical tests."

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their specific qualifications. For blood glucose monitoring systems, the "ground truth" is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than expert consensus on visual interpretation.

4. Adjudication Method

The document does not mention an adjudication method, which is generally not applicable for performance studies of blood glucose meters where comparisons are made against a laboratory reference method rather than subjective expert interpretations.

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

An MRMC study is not relevant for this type of device (blood glucose monitoring system). Blood glucose meters are assessed for their accuracy in quantifying glucose levels, not for improved human interpretation or diagnostic capabilities with AI assistance. Therefore, no information on an MRMC study or effect size of AI assistance for human readers is provided or expected.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Non-clinical and clinical tests for the Gmate® SMART Blood Glucose System" evaluated the device's performance, functionality, and reliability. This would inherently be a standalone evaluation of the algorithm and device's measurement capabilities without human-in-the-loop performance being a primary metric. The system's ability to accurately measure glucose and display results on the connected Apple device constitutes its standalone performance.

7. Type of Ground Truth Used

The ground truth for the clinical performance evaluation (specifically system accuracy) would be laboratory reference method measurements of blood glucose. While not explicitly stated, this is the standard for evaluating blood glucose monitoring systems against ISO 15197. These reference measurements are typically obtained using highly accurate laboratory instruments (e.g., a YSI analyzer).

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of device development. Blood glucose monitors primarily use a fixed algorithm and calibration rather than machine learning models that require a distinct training set. The calibration and factory settings would be established during manufacturing based on extensive testing and quality control processes.

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

As noted above, the concept of a "training set" for a machine learning model is not explicitly detailed or indicated for this device. The device's underlying "algorithm" (the conversion of the electrochemical signal to a glucose reading) is based on established electrochemical principles and calibration. The ground truth for establishing and verifying this algorithm/calibration would be through laboratory reference method measurements using standard glucose solutions and blood samples across the device's measurement range, similar to how the clinical test set's ground truth is established.

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