(352 days)
The GAL-1C 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 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-1C Blood Glucose Test Strips are to be used with the GAL-1C Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
The GAL-1C blood glucose meter and GAL-1C test strips used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions for quality control testing
The GAL-1C Blood Glucose Monitoring System is intended for quantitative measurement of glucose in fresh capillary whole blood samples. The acceptance criteria and details of the studies conducted are as follows:
1. Table of Acceptance Criteria & Reported Device Performance:
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the GAL-1C Blood Glucose Monitoring System against a pre-defined standard (e.g., ISO 15197). Instead, it states that "Results demonstrate substantial equivalence to the predicate device meter, test strips, and control solutions." and "Clinical and non-clinical testing demonstrated that the GAL-1C system performs in a substantially equivalent manner to that of the predicate system."
However, the non-clinical and clinical testing sections list various parameters that were evaluated, which implicitly serve as performance indicators contributing to the substantial equivalence claim. Since quantitative acceptance criteria are not explicitly stated, I will list the areas of testing performed.
| Acceptance Criteria (Implied) | Reported Device Performance and Study Type |
|---|---|
| Non-Clinical Testing: | |
| Software Verification and Validation | Conducted: Software verification and validation results demonstrated substantial equivalence. |
| Software Integration | Conducted: Software integration results demonstrated substantial equivalence. |
| Linearity | Conducted: Linearity results demonstrated substantial equivalence. |
| Lo/Hi Detection | Conducted: Lo/Hi detection results demonstrated substantial equivalence. |
| Drop Testing | Conducted: Drop testing results demonstrated substantial equivalence. |
| EMC and Electrical Safety | Conducted: EMC and Electrical Safety results demonstrated substantial equivalence. |
| Strip Non-interchangeability (new vs. predicate) | Conducted: Verification of strip noninterchangeability between new and predicate devices results demonstrated substantial equivalence. |
| Precision | Conducted: Precision results demonstrated substantial equivalence. |
| Interferences | Conducted: Interferences results demonstrated substantial equivalence. |
| Minimum Sample Volume | Conducted: Minimum sample volume results demonstrated substantial equivalence. |
| Altitude | Conducted: Altitude results demonstrated substantial equivalence. |
| Hematocrit | Conducted: Hematocrit results demonstrated substantial equivalence. |
| Humidity and Temperature | Conducted: Humidity and temperature results demonstrated substantial equivalence. |
| Control Solution Qualification | Conducted: Control solution qualification results demonstrated substantial equivalence. |
| Environmental Conditions Testing | Conducted: Environmental conditions testing results demonstrated substantial equivalence. |
| Test Strip Shelf Life and Use Life | Conducted: Test strip shelf life and use life results demonstrated substantial equivalence. |
| Control Solution Shelf Life and Use Life | Conducted: Control solution shelf life and use life results demonstrated substantial equivalence. |
| Battery Life Testing | Conducted: Battery life testing results demonstrated substantial equivalence. |
| Disinfection Effectiveness (accuracy post-disinfection) | Conducted: Disinfection testing showed that the system remained accurate after multiple disinfections to simulate a lifetime of treatments. |
| Disinfectant Material Ability to Inactivate Hepatitis B | Conducted: Evaluation was done to demonstrate the ability of the selected disinfectant material to inactivate Hepatitis B. |
| Clinical Testing: | |
| Accuracy (Healthcare Professionals) | Conducted: An accuracy study was performed with blood testing by healthcare professionals. Results demonstrated substantial equivalence. |
| User Performance (Self-testing at Finger, Palm, Forearm) | Conducted: A User Performance study was conducted with self-testing at finger, palm, and forearm sites. Results demonstrated substantial equivalence. |
| Ease-of-Use and Ease-of-Understanding of User's Manual (User Study) | Conducted: A User Study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual. Results demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size used for the clinical accuracy study or the user performance study. It only mentions that an "accuracy study was performed" and a "User Performance study was conducted."
The country of origin for the data and whether the studies were retrospective or prospective are not specified in the provided 510(k) summary. Given the submitter's location (Hsinchu, CHINA (TAIWAN)), it's plausible the studies were conducted there, but this is not confirmed.
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):
For the accuracy study, it states "An accuracy study was performed with blood testing by healthcare professionals." The number of healthcare professionals and their specific qualifications are not specified. For glucose monitoring systems, "healthcare professionals" typically refer to phlebotomists, nurses, or lab technicians performing comparative measurements against a gold standard laboratory method. The document does not mention "experts" in the sense of adjudicators for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe an adjudication method for establishing ground truth, as it relates to expert consensus for image interpretation. For glucose meters, the "ground truth" is typically established by a laboratory reference method (e.g., YSI analyzer) against which the device's readings are compared.
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 this device. The GAL-1C Blood Glucose Monitoring System is a self-testing blood glucose meter, not an imaging device that would typically involve human readers or AI assistance. No MRMC study was mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a blood glucose monitoring system, and its "standalone" performance refers to the device itself providing a reading. The accuracy study (performed by healthcare professionals) and user performance study (self-testing) both evaluate the device's standalone performance in producing glucose measurements. The "algorithm" in this context is the internal processing of the meter to convert the electrochemical signal from the test strip into a glucose reading. Therefore, the accuracy data from these studies represent the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For blood glucose meters, the ground truth is typically established by a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose measurements from venous plasma or whole blood. While not explicitly stated, this is the standard ground truth for such devices. The statement "An accuracy study was performed with blood testing by healthcare professionals" implies a comparison to a more accurate reference method.
8. The sample size for the training set:
Blood glucose monitoring systems like the GAL-1C historically do not use "training sets" in the context of machine learning algorithms that require large datasets for model development. While the system has "meter software," the development process of such software typically involves engineering design, calibration, and verification/validation, rather than machine learning training. Therefore, no "training set" in the machine learning sense is referenced or implied.
9. How the ground truth for the training set was established:
As there is no mention of a machine learning "training set," the method for establishing its ground truth is not applicable and therefore not described. The ground truth for the calibration of the device and test strips would have been established through controlled laboratory experiments using reference methods.
§ 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.