(86 days)
GAL-1A Blood Glucose Monitoring System: The GAL-1A 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.
GAL-1A Blood Glucose Test Strips: The GAL-1A Blood Glucose Test Strips are to be used with the GAL-1A 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 GAL-1A blood glucose meter and GAL-1A test strips are used for testing of blood glucose by self-testers at home. Contrex Plus III Glucose Control Solutions are used for quality control testing of the system.
Here's a breakdown of the acceptance criteria and study information for the GAL-1A Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the device being "substantially equivalent" to a predicate device (GAL-1C Blood Glucose Monitoring System K102816). Specific numerical acceptance criteria for blood glucose accuracy are not explicitly stated in the provided documents but are inferred through the declaration of substantial equivalence based on non-clinical and clinical testing. For blood glucose monitoring systems, substantial equivalence often implies meeting the ISO 15197:2003 or later standards (or equivalent FDA guidance thresholds) for accuracy. However, without specific thresholds mentioned, we can only state that the device met the performance deemed substantially equivalent.
| Acceptance Criteria Category | Specific Criteria (Explicit/Inferred) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | - EMC and Electrical Safety compliant | "Results demonstrate substantial equivalence to the predicate system." |
| - Drop testing robust | "Results demonstrate substantial equivalence to the predicate system." | |
| - Disinfection performance (robustness to multiple cleanings and disinfections) sufficient | "Results demonstrate substantial equivalence to the predicate system." | |
| - Software verification and validation (functional and reliable) | "Results demonstrate substantial equivalence to the predicate system." | |
| - Linearity testing with validation of Lo/Hi detection accurate | "Results demonstrate substantial equivalence to the predicate system." | |
| Clinical Testing | - Ease-of-use (for self-testers) | "Results demonstrate substantial equivalence to the predicate system." |
| - Ease-of-understanding of User's Manual | "Results demonstrate substantial equivalence to the predicate system." | |
| Overall Performance | - Perform in a substantially equivalent manner to the predicate device (GAL-1C, K102816) | "Clinical and non-clinical testing demonstrated that the GAL-1A system performs in a substantially equivalent manner to that of the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the "user study" (clinical testing) or for the non-clinical tests (e.g., how many units were drop-tested, how many linearity measurements were taken, how many participants were in the user study). It only states "a user study was conducted."
- Data Provenance: The manufacturing company, Apex Biotechnology Corp., is located in China (Taiwan). It is highly probable that the testing, both non-clinical and clinical, was conducted in Taiwan or a region accessible to them, but this is not explicitly stated. The document doesn't specify if the data was retrospective or prospective, but clinical "user studies" are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" for glucose levels is typically established by a laboratory reference method (e.g., YSI analyzer) rather than human experts interpreting results. The user study focused on "ease-of-use" and "ease-of-understanding," which would be evaluated by the target user population rather than highly specialized experts.
4. Adjudication Method for the Test Set
This information is not provided. Given that the clinical study was primarily a "user study" for ease-of-use and understanding, and analytical performance (accuracy) is typically compared against a reference lab method, a traditional multi-expert adjudication method (like 2+1 or 3+1) is unlikely to have been applied in the context usually seen with diagnostic image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that would involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary evaluation of the device's core function (measuring blood glucose) is inherently a standalone performance assessment. The "GAL-1A meter uses the same test algorithm as the predicate meter," and its performance is compared to the predicate's established analytical accuracy through linearity testing. The "user study" then assesses the human-in-the-loop aspects of ease-of-use, but the core measurement is standalone.
7. The Type of Ground Truth Used
The ground truth for the analytical performance (glucose concentration measurement) would typically be established by a laboratory reference method (e.g., a YSI glucose analyzer) that is considered the gold standard for accurate glucose measurement. The documentation states "linearity testing with validation of Lo/Hi detection," which implicitly relies on comparison with such established reference values. For the user study, the "ground truth" for ease-of-use and understanding would be derived from user feedback and observational data.
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this device. The GAL-1A blood glucose meter uses an algorithm that is stated to be "the same test algorithm as the predicate meter." Blood glucose meters typically rely on electrochemical reactions and pre-calibrated algorithms, rather than machine learning models that require distinct "training sets" in the modern AI sense. The development of the algorithm for the predicate device would have involved calibration and validation data, but this wouldn't be referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a "training set" in the machine learning sense is not applicable here. The original algorithm for the predicate device would have been developed and calibrated using blood samples with glucose concentrations determined by a laboratory reference method, but the specifics of that process are not detailed for the GAL-1C device or its algorithm.
§ 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.