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

The Gmate® Origin Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Gmate® Origin Glucose Monitoring System 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® Origin Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, palm, thigh or calf.

The Gmate® Origin Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® Origin 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® Origin 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 Gmate® Origin Blood Glucose Monitoring System do not require coding or calibration and uses 1 CR2032 (Lithium Ion Battery). Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds countdown to display the test result.

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 ar electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level.

The document provided describes the Gmate® Origin Blood Glucose Monitoring System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose meters typically follow ISO 15197 standards. While the specific numerical thresholds for each criterion are not explicitly stated in this document, it refers to "pre-determined Pass/Fail Criteria" and meeting "all the reliability requirements and performance claims." The performance is compared against the YSI 2300 Glucose Analyzer as a reference.

Note: The document states that the device "met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria." However, the exact numerical acceptance limits and detailed results (e.g., percentage within ±15% or ±20% of reference) are not provided in this summary.

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

• Sample Size for Test Set: 100 persons.
• Data Provenance: The study involved 100 persons with diabetes and healthcare professionals "at a clinic center." The manufacturer's address includes "Republic of Korea" and "New York, NY, USA." Without further detail, it's not definitively clear if the clinical testing was conducted in Korea, the USA, or both. The study appears to be prospective as it involved measurements "obtained by patients with those obtained using the YSI 2300 Glucose Analyzer."

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

The document mentions that the test set data was collected from "100 persons with diabetes and healthcare professionals at a clinic center." The ground truth was established by comparing the device readings to results from a "YSI 2300 Glucose Analyzer, a laboratory instrument." The YSI 2300 is a highly accurate laboratory reference method for glucose measurement, and its calibration and operation would typically be performed by trained laboratory technicians or clinical staff, who could be considered experts in reference glucose measurement. However, the exact number and specific qualifications of the experts directly involved in establishing the "ground truth" (i.e., operating the YSI analyzer and interpreting its results for the study) are not specified.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Instead, it directly compares the Gmate® Origin readings to the laboratory reference standard (YSI 2300 Glucose Analyzer). Adjudication methods are more commonly used in studies involving subjective interpretations (e.g., medical imaging) to resolve discrepancies between readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or designed for this device. This type of study focuses on the diagnostic accuracy of human readers with and without AI assistance, which is generally not applicable to a blood glucose monitoring system that provides a direct numerical reading. The study focuses on the accuracy of the device itself compared to a reference standard.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "clinical performance evaluation testing included system accuracy, user performance, and alternative-site blood glucose measurement." These evaluations assessed the Gmate® Origin system's performance by comparing its readings directly with those obtained from the YSI 2300 Glucose Analyzer. This is a standalone evaluation of the algorithm/device as it functions independently to provide a glucose reading.

7. Type of Ground Truth Used

The type of ground truth used was a laboratory reference method – specifically, the YSI 2300 Glucose Analyzer. This is considered a highly accurate and reliable method for determining blood glucose concentration.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It primarily describes the performance evaluation studies. For devices like blood glucose meters with electrochemical principles, extensive "training data" in the AI/machine learning sense is not typically a primary component of their development and validation as it would be for pattern recognition or image analysis algorithms. Instead, their development relies on chemical and electrochemical engineering, and their validation on analytical performance studies. If there were any internal calibration or algorithm refinement using data, that information is not disclosed in this summary.

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

As noted above, information about a "training set" in the context of machine learning (and its associated ground truth) is not provided. The development and validation of this device likely relied on standard analytical chemistry and engineering principles, with performance validated through clinical and non-clinical studies against a laboratory reference.

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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, 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 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 jack of the Apple/Android 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/Android device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently with Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4th generation, iPad, and iPad2) and now with the following Android devices: Samsung Galaxy S3, S4, and S5; 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/Android device.

Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for accuracy. However, it does state an overall conclusion: "The results demonstrated that the Gmate® SMART met all the reliability requirements and performance claims." and "Based on the comparisons completed of the clinical and non-clinical tests performed, the devices passed all of the tests based on pre-determined Pass/Fail Criteria."

To infer the acceptance criteria for accuracy, we typically refer to ISO 15197 for blood glucose monitoring systems. While not directly stated, the study implies adherence to these standards by mentioning "FDA Guidance Documents and CLSI reference standards." The YSI 2300 Glucose Analyzer is the widely accepted reference method for accuracy in these types of studies. The performance is reported as meeting "all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: "Glucose levels were measured on 100 persons with diabetes and healthcare professionals at a clinic center."
• Data Provenance: The document does not explicitly state the country of origin where the clinical study took place. It mentions Philosys, Inc. has a New York Office and a Seoul Office (South Korea). It also states "clinical tests... were performed in accordance with FDA Guidance Documents and CLSI reference standards," which suggests the study was designed to meet US regulatory requirements. The study appears to be prospective as it involves performance evaluations on individuals, rather than analyzing existing datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• The ground truth was established using the YSI 2300 Glucose Analyzer, a laboratory instrument.
• The document mentions "healthcare professionals at a clinic center" were involved in measuring glucose levels, but it doesn't specify the number or specific qualifications of these professionals for establishing the ground truth. Their role was likely to operate the YSI 2300 and collect samples, not to interpret or adjudicate results in the way an "expert" would for image-based diagnostics.

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

• No adjudication method (like 2+1 or 3+1 consensus) is described. This is expected for a blood glucose monitoring system where the YSI 2300 Glucose Analyzer itself serves as the objective reference standard, not human interpretation.

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 MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices (e.g., radiology AI) where human readers make diagnoses. The Gmate® SMART is a quantitative measurement device, not an interpretative one in the sense of an MRMC study.

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

• Yes, a standalone performance evaluation was done. The device's accuracy was assessed by comparing its glucose readings directly against a laboratory reference instrument (YSI 2300 Glucose Analyzer). While users operate the device, the core performance being evaluated is the algorithm/system's ability to accurately measure glucose, independent of human interpretive bias. The study also included "user performance" which might incorporate human interaction, but the primary accuracy assessment is standalone.

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

• The ground truth used was reference laboratory measurement from a YSI 2300 Glucose Analyzer. This is considered a highly accurate and objective standard for glucose concentration.

8. The sample size for the training set:

• The document does not provide information about a training set. This is common for this type of device, where analytical and clinical performance studies are conducted, rather than machine learning model training in the typical sense. The device's underlying measurement principle is electrochemical, not a learned algorithm requiring a separate training set.

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

• As no training set is mentioned or implied, this question is not applicable based on the provided text.

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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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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

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