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GAL-1A Plus Blood Glucose Monitoring System: GAL-1A Plus Blood Glucose Monitoring System is comprised of the GAL-1A Plus Blood Glucose Meter, the GAL-1A Blood Glucose Test Strips. The GAL-1A Plus 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-1A Plus blood glucose monitoring system consists of the GAL-1A Plus meter and GAL-1A Test Strips. It is used for testing of blood glucose by self-testers at home.

This document describes a 510(k) premarket notification for the GAL-1A Plus Blood Glucose Monitoring System, which does not contain an AI/ML component. Therefore, the questions related to AI/ML specific criteria like "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for the training set" are not applicable.

Here's the available information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The provided text focuses on the substantial equivalence determination and does not detail specific quantitative acceptance criteria or corresponding performance data for the GAL-1A Plus Blood Glucose Monitoring System beyond the disinfectant performance. It states that "Disinfection performance (robustness of meter to multiple cleanings and disinfections) was conducted. Results demonstrate substantial equivalence to the predicate system." This implies the performance met the criteria for substantial equivalence regarding disinfection, but the numerical criteria and results are not provided.

2. Sample sized used for the test set and the data provenance

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set for clinical performance and no data provenance information for such a set. For the non-clinical disinfection performance, the sample size and data provenance are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical testing was conducted and the device does not have an AI/ML component.

4. Adjudication method for the test set

Not applicable, as no clinical testing was conducted and the device does not have an AI/ML component.

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, as the device does not have an AI/ML component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device does not have an AI/ML component.

7. The type of ground truth used

For the non-clinical disinfection performance, the "ground truth" would likely be a pre-defined standard or method for evaluating the robustness to cleaning and disinfection, which is not detailed but assumed to be met for substantial equivalence. For clinical performance, no ground truth was established as no clinical testing was performed.

8. The sample size for the training set

Not applicable, as no AI/ML component is mentioned or implied.

9. How the ground truth for the training set was established

Not applicable, as no AI/ML component is mentioned or implied.

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