(286 days)
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."
| Performance Metric | Acceptance Criteria (Inferred from regulatory standards) | Reported Device Performance |
|---|---|---|
| System Accuracy | Typically based on ISO 15197 (e.g., >95% of results within ±15 mg/dL or ±15% of reference for specific glucose ranges) | "Met all the reliability requirements and performance claims" and "passed all of the tests based on pre-determined Pass/Fail Criteria." |
| Precision | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Linearity | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Interference | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Hematocrit | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Altitude | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Temperature/Humidity | Not explicitly defined, but implied by "passed all of the tests" | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| User Performance | Successful completion of tests by users | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
| Alternate Site Testing | Successful completion of tests | "Evaluations... conducted to establish the performance, the functionality and the reliability characteristics" |
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.