(430 days)
The MyGlucoHealth Wireless 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 glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).
The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930).
The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
Here's a breakdown of the acceptance criteria and the study information for the MyGlucoHealth Wireless System, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
The provided document refers to the ISO 15197:2003 standard, which outlines requirements for blood glucose monitoring systems. While the specific numerical acceptance criteria from this standard are not explicitly listed in detail within the summary, the summary states that "All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate."
A key aspect of performance for blood glucose monitoring systems is accuracy. Although a detailed table of performance against specific accuracy thresholds (e.g., within X% of a reference method) is not present in this summary, the substantial equivalence claim implies that its performance is comparable to the predicate device, which would have met such criteria.
Note: For a complete understanding of the device's accuracy against ISO 15197:2003, one would typically need to refer to the full test report or the specific performance data submitted with the 510(k) application, which is not fully included here. However, the mention of the standard indicates the type of criteria the device aims to meet.
| Acceptance Criteria Category (Implied by ISO 15197:2003, and by "substantial equivalence") | Reported Device Performance (Summary) |
|---|---|
| Accuracy of glucose measurement (within defined limits) | Demonstrated "safety and effectiveness" and "substantial equivalence to the predicate." |
| Repeatability/Precision | Implied to meet acceptable standards for blood glucose meters. |
| Interference with common substances | Implied to meet acceptable standards for blood glucose meters. |
| System operating conditions (temperature, humidity) | Meets specified operating range: 10-40°C (50-104°F), 10-90% humidity. |
| Hematocrit range | 20-60% |
| Test range | 10-600 Mg/dL |
| Test time | 3 seconds |
| Sample Volume | 0.3 uL |
| Cleaning and Disinfection Robustness (for re-use) | No change in functional performance or visual materials after 156 cleaning/disinfection cycles (simulating 3 years of use). |
| Disinfection Efficacy against pathogens | Demonstrated complete inactivation of duck hepatitis B virus with Caviwipes XL. |
Study Information
The document describes non-clinical testing and clinical testing.
2. Sample size used for the test set and the data provenance:
- Non-Clinical Testing:
- Cleaning Validation Test (Robustness): 3 different meters were tested.
- Cleaning Validation Test (Efficacy): The sample size for materials tested for disinfection efficacy is not specified, but it was performed by an outside testing laboratory.
- Clinical Testing (Human Factor testing): The sample size is not specified in the provided summary.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the clinical (human factors) study, or the non-clinical testing. However, given it's for FDA submission, it's generally expected to be prospective for human factors and laboratory-controlled for non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. For a blood glucose meter, the "ground truth" for accuracy assessments is typically established by comparative measurements against a well-established laboratory reference method (e.g., YSI analyzer), rather than expert consensus on individual readings.
- For the human factors testing, the definition of ground truth (e.g., successful task completion) would be based on predefined criteria, not expert assessment of individual readings.
4. Adjudication method for the test set:
- Not applicable in the context of this summary. Blood glucose meter performance is determined by quantitative comparison to reference methods, not subjective interpretation requiring adjudication among experts. For human factors, task completion or error rates would be measured against predefined success/failure criteria.
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:
- This is not applicable to a blood glucose monitoring system like the MyGlucoHealth Wireless System. MRMC studies are typically used for imaging diagnostics where human readers interpret medical images, often with AI assistance. This device is a standalone in vitro diagnostic (IVD) device for quantitative measurement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the core performance evaluation of the MyGlucoHealth Wireless System is a standalone evaluation. The device itself measures glucose concentration and displays a numerical result. The "algorithm" here refers to the electrochemical principles and calibration within the test strip and meter to convert a biochemical reaction into a glucose reading. The system's accuracy is assessed directly against a reference method.
7. The type of ground truth used:
- For glucose measurement accuracy: Typically, a laboratory reference method (e.g., YSI glucose analyzer) is used as the ground truth. This is implied by the adherence to ISO 15197:2003, which requires comparison to a traceable reference measurement procedure.
- For cleaning/disinfection efficacy: Specific laboratory standards for viral inactivation are used.
- For human factors: Predefined criteria for task completion and user comprehension are typically used to establish ground truth.
8. The sample size for the training set:
- This information is not explicitly provided. For a traditional electrochemical blood glucose meter, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, using a variety of samples during development and manufacturing to establish its operating characteristics.
9. How the ground truth for the training set was established:
- Not applicable in the machine learning context. For this type of device, ground truth for calibration and development would be established through precise laboratory measurements using reference methods and well-characterized samples over a range of glucose concentrations, hematocrit levels, and interfering substances.
§ 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.