(106 days)
The FORA G30 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm. the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA G30 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
FORA G30 Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided documentation is a 510(k) summary for the FORA G30 Blood Glucose Monitoring System. It describes the device, its intended use, and states that performance studies were conducted. However, it does not provide specific acceptance criteria or detailed results of those studies. The document confirms that the device was found to have "satisfactory performance" and be "suitable for its intended use" based on laboratory and clinical settings studies, but it lacks the quantitative data to fill out your requested table and answer many specific questions.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | "demonstrates satisfactory performance" and "meets its intended use." Specific quantitative performance metrics (e.g., accuracy percentages, bias, precision) are not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not specified.
- Data provenance: "studied in the laboratory and in clinical settings". The country of origin is not explicitly stated for the studies themselves, but the submitter is from Taiwan. It's not specified if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified. The studies involved "healthcare professionals and lay users," but the role of experts in establishing ground truth is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not specified.
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:
- MRMC comparative effectiveness study: Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: The device itself is standalone in the sense that it provides a direct measurement. The performance studies would inherently assess the algorithm (meter and test strips) without human intervention in the result generation process. However, the document doesn't explicitly refer to "standalone performance" in the context of an algorithm separate from the device's main function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Not explicitly stated. For a blood glucose monitoring system, the ground truth would typically be established by a reference laboratory method (e.g., YSI analyzer) for comparison, but this is not specified in the provided text.
8. The sample size for the training set:
- Sample size for training set: Not specified. The document mentions "performance studies" but does not differentiate between training and test sets or their sizes.
9. How the ground truth for the training set was established:
- How ground truth for training set was established: Not specified.
§ 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.