(71 days)
GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.
The GlucoBalance Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. The subject device consists of a data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. It should be noted that the software does not recommend any medical treatment or medication dosage level.
The provided text describes the 510(k) submission for the GlucoBalance Data Management Software. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a definitive study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally refers to "appropriate functional characteristics" and "ease of operation by in-home users." | "demonstrate appropriate functional characteristics" |
| "demonstrated the systems ability to be easily operated by in-home users." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "consumer studies" but does not give a sample size.
- Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is data management software, not a diagnostic tool where expert ground truth would typically be established for classification tasks. The "ground truth" here would likely be the accurate transfer and display of blood glucose data, validated against the meter's internal memory or direct meter readings.
4. Adjudication method for the test set
- Not applicable/Not specified. Given the nature of the device (data management software), an adjudication method as typically applied in diagnostic image analysis or similar fields is unlikely to be relevant or detailed here.
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
- No MRMC comparative effectiveness study was done or reported. This device is data management software, not an AI-powered diagnostic tool, so this type of study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "performance testing to demonstrate appropriate functional characteristics" and "validation of the systems hardware (the data transfer cable) and software" likely represent standalone testing of the device's ability to transfer, store, and display data correctly. The "consumer studies" for ease of operation would involve human interaction but not in the sense of "human-in-the-loop performance" for a diagnostic algorithm.
7. The type of ground truth used
- The ground truth would be the accurate representation of blood glucose data as recorded by the blood glucose meters. This would involve comparing the data downloaded and displayed by the GlucoBalance software against the raw data stored in the connected blood glucose meters, or potentially against manual readings/logs. This is an accuracy assessment of data transfer and display, not a clinical outcome or pathology ground truth.
8. The sample size for the training set
- Not applicable/Not specified. This is software for data management, not a machine learning model that requires a training set in the conventional sense. Software development involves testing, but not typically "training sets" as understood in AI/ML contexts.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document states that the device underwent "Safety Testing: performance testing to demonstrate appropriate functional characteristics." This included:
- Validation of the system's hardware (the data transfer cable).
- Validation of the software.
- Consumer studies "that demonstrated the systems ability to be easily operated by in-home users."
The conclusion drawn from this testing was that "The GlucoBalance Data Management Software is substantially equivalent to the Camit Data Management System from Roche Diagnostics Corp. (K001907)." This implies that the performance in these unspecified tests was deemed sufficient to meet the FDA's requirements for substantial equivalence.
In essence, the provided document offers a high-level summary of testing but lacks the granular details typically present in a full study report to address all your specific questions.
§ 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.