(413 days)
The GlucoSure Link Blood Glucose Monitoring System is comprised of GlucoSure Link Blood Glucose Meter and GlucoSure Link Blood Glucose Test Strips.
The GlucoSure Link 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). This system is intended for self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of your diabetes control and should only be used by a single patient and not be shared. It is not intended to be used for the diagnosis or screening of diabetes or for use on neonates.
The GlucoSure Link blood glucose monitoring system consists of the GlucoSure Link meter, GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution. It is used for testing of blood glucose by self-testers at home. The GlucoSure Link Blood Glucose Test Strips and Contrex Plus glucose control solution are purchased separately.
The modified device of GlucoSure Link glucose meter is derived from the existing device of AutoSure Voice II meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile device and removed the voice Feature.
The glucose test strips and glucose control solution utilized in the GlucoSure Link Blood Glucose Monitoring System are the same as the AutoSure glucose test strips and Contrex Plus Glucose Control Solution, previously cleared in K102037.
The meter materials of GlucoSure Link glucose meter are the same as the AutoSure Voice II meter. Therefore, the disinfection performance (robustness of meter to multiple cleanings and disinfections) was previously cleared in K150396.
The provided text does not contain detailed information about acceptance criteria and the study proving the device meets these criteria in the context of advanced AI-driven medical devices. Instead, it is an FDA 510(k) summary for a blood glucose monitoring system, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific acceptance criteria.
Therefore, I cannot extract the information required by your prompts regarding AI performance metrics, expert consensus, MRMC studies, or training/test set details for an AI model.
However, I can extract information related to the device described in the document, which is a Blood Glucose Monitoring System. Here's what I can provide based on the given text:
Device: GlucoSure Link Blood Glucose Monitoring System
1. A table of acceptance criteria and the reported device performance:
The document mentions "linearity, precision, short sample detection, intermittent sampling, sample perturbation, temperature and humidity testing" as non-clinical testing conducted, and "method comparison and user studies for glucose" as clinical testing. It states that "results demonstrate substantial equivalence to the predicate system," but does not provide specific numerical acceptance criteria or performance metrics in a defined table format. For blood glucose monitoring systems, performance is typically evaluated against standards like ISO 15197, which define accuracy criteria (e.g., percentage of results within a certain deviation from a reference method). These specific numerical criteria and the device's performance against them are not detailed in this summary.
The document only broadly states:
- "Method comparison and user studies for glucose were conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system."
- "Accuracy at extreme glucose values were also evaluated." (No specific results provided)
- "Clinical and analytical testing demonstrated that the GlucoSure Link Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate."
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for either non-clinical or clinical testing. The document generally mentions "method comparison and user studies."
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given that the submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan, and the device is intended for "self-testing (outside the body, or In Vitro Diagnostic use) by people with diabetes at home," the studies would likely involve prospective collection of human blood samples in a clinical setting or by home users. However, the specific location and nature (retrospective/prospective) of the data collection are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device and the type of evaluation described. For blood glucose monitoring systems, the "ground truth" (reference measurement) is typically established using a highly accurate laboratory reference method (e.g., hexokinase or glucose oxidase methods on a spectrophotometer), not human expert review. The document does not mention human experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication processes (like 2+1 or 3+1 expert consensus) are typically used for subjective interpretations, such as image analysis for AI models. For a quantitative device like a blood glucose meter, the ground truth is a numerical measurement from a reference instrument.
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:
- Not applicable. This device is a blood glucose monitoring system, not an AI-driven image analysis or diagnostic tool that assists human readers. Therefore, an MRMC study and
measurement of human reader improvement with AI assistance are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The GlucoSure Link Blood Glucose Monitoring System itself performs the measurement. Its "algorithm" is the measurement methodology. The "standalone performance" is essentially the device's accuracy and precision compared to a reference method, which is generally what "method comparison" studies evaluate. The document indicates these studies were performed, showing "substantial equivalence."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood glucose measurements is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) that are highly accurate and precise. The document implies "method comparison" studies were done, which means the device's readings were compared against such a reference method.
8. The sample size for the training set:
- Not explicitly stated. For a blood glucose meter, "training" might refer to the initial development and calibration of the electrochemical system and algorithms. This information is typically part of the device's internal development process and not usually detailed as a "training set" sample size in an FDA 510(k) summary in the way it is for AI models.
9. How the ground truth for the training set was established:
- Similar to point 8, the "ground truth" for the development and calibration of the device would likely be established using laboratory reference methods to ensure the meter's internal algorithms accurately convert electrochemical signals into glucose readings.
§ 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.