(318 days)
The GAL-1F Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring blood glucose levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-1F Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring blood glucose levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancets. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The GAL-1F blood glucose monitoring system consists of the GAL-1F meter and GAL-1F Test Strips. It is used for testing of blood glucose by self-testers at home. The GAL-1F Pro blood glucose monitoring system consists of the GAL-1F Pro meter and GAL-1F Pro Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The GAL-1F and GAL-1F Pro systems are identical other than trade names and details of product labeling.
Here's an analysis of the acceptance criteria and study information for the GAL-1F Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, based on the description of the clinical testing, the implied acceptance criterion is substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Substantial equivalence to the predicate device (GAL-1E and GAL-1E Multi) | Demonstrated substantial equivalence to the predicate device. |
| Ease-of-Use | Substantial equivalence to the predicate device | Demonstrated substantial equivalence to the predicate device. |
| Ease-of-Understanding (of instructions for use) | Substantial equivalence to the predicate device | Demonstrated substantial equivalence to the predicate device. |
Study that Proves Device Meets Acceptance Criteria:
The study referenced is an "accuracy user study" and an "Ease-of-Use and Ease-of-Understanding (of the instructions for use) questionnaire." The conclusion states that "Clinical and non-clinical testing show that the GAL-1F / GAL-1F Pro Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for accuracy user study: 114 self-testers and an unspecified number of professional tests. 106 unaltered samples were tested by self-testers.
- Data Provenance: The document (specifically the 510(k) Summary) lists the submitter's address as "Hsinchu, 30078 CHINA (TAIWAN)". This suggests the studies were likely conducted in Taiwan. The study is referred to as "clinical testing," which typically implies prospective data collection for the purpose of a regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. This is generally not applicable to blood glucose measurements, where the reference method provides a definitive numerical value.
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 as the device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or classification system that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone blood glucose monitoring system. The accuracy user study assesses the system's performance (meter + test strip + user interaction) against a reference, which inherently represents its "standalone" performance in its intended use environment.
7. The Type of Ground Truth Used
For the accuracy study, the ground truth for blood glucose levels would have been established by a laboratory reference method (e.g., YSI analyzer), though this is not explicitly stated in the provided text. The document refers to "unaltered samples" and "accuracy user study," which implies comparison against a highly accurate gold standard for glucose measurement.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. For a traditional blood glucose meter, the "training" (development and calibration) would involve a series of samples used to establish the meter's calibration curve. The size of this internal development dataset is not disclosed here. The provided data pertains to clinical validation/testing.
9. How the Ground Truth for the Training Set Was Established
As with the test set, if a "training set" were explicitly for calibrating the device, the ground truth would typically be established using a laboratory reference method for glucose measurement. However, as noted above, a distinct "training set" in the AI sense is not discussed for this type of device.
§ 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.