(165 days)
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.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| System Accuracy | Demonstrated to meet reliability requirements and performance claims. |
| User Performance | Demonstrated to meet reliability requirements and performance claims. |
| Alternate-Site Blood Glucose Measurement | Demonstrated to meet reliability requirements and performance claims. |
| Precision | Passed test based on pre-determined Pass/Fail Criteria. |
| Linearity | Passed test based on pre-determined Pass/Fail Criteria. |
| Interference | Passed test based on pre-determined Pass/Fail Criteria. |
| Hematocrit | Passed test based on pre-determined Pass/Fail Criteria. |
| Altitude | Passed test based on pre-determined Pass/Fail Criteria. |
| Temperature/Humidity | Passed test based on pre-determined Pass/Fail Criteria. |
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.
§ 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.