(106 days)
The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus.
GlucoSure Star consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.
Here's an analysis of the acceptance criteria and study information for the GlucoSure Star Blood Glucose Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly states that "Results met pass/fail performance criteria" without detailing the specific criteria or the exact performance values achieved. Based on the "Functional and Safety Testing" section, the evaluation methods were linear regression analysis, Clarke Error Grid analysis, and bias analysis. While the document asserts the results met criteria, the specific numerical targets for these analyses are not mentioned.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific Pass/Fail Performance Criteria for Linear Regression Analysis | "Results met pass/fail performance criteria." |
| Specific Pass/Fail Performance Criteria for Clarke Error Grid Analysis | "Results met pass/fail performance criteria." |
| Specific Pass/Fail Performance Criteria for Bias Analysis | "Results met pass/fail performance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text only mentions "Clinical testing was done with persons with diabetes."
- Data Provenance: Not explicitly stated. It indicates "Clinical testing was done with persons with diabetes." The submitter is from Taiwan, ROC, which might imply the study was conducted there, but this is not confirmed. The study was retrospective or prospective is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The text states, "Professional fingertip meter results were compared with AST results collected both by professionals and by persons with diabetes." This implies healthcare professionals were involved in collecting data and establishing comparison points, but their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
4. Adjudication Method
- Adjudication Method: Not explicitly stated. The study involved comparing professional fingertip meter results with AST results. It doesn't describe a process of multiple experts independently reviewing and then adjudicating discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is typically for evaluating human reader performance with and without AI assistance for interpretative tasks. The GlucoSure Star is a blood glucose monitoring system, and its evaluation focuses on the accuracy of its quantitative measurements against a reference.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in essence. The study's purpose was to verify the proper performance of the device itself (GlucoSure Star) for Alternate Site Testing (AST). While humans (professionals and persons with diabetes) collected the samples and operated the device, the core evaluation was the accuracy of the device's measurements compared to a reference method (professional fingertip meter results). The "algorithm" here is the device's inherent measurement capability.
7. Type of Ground Truth Used
- Ground Truth Type: Clinical comparison to a predicate/reference method. The study used "Professional fingertip meter results" as the comparison/reference point for the Alternate Site Testing (AST) results from the GlucoSure Star. This is a common approach for establishing the accuracy of new blood glucose monitoring systems against established, accepted methods.
8. Sample Size for the Training Set
- Sample Size: Not applicable/not stated. The provided text describes a clinical validation study for the device, not a study for an AI algorithm that typically requires a training set. The GlucoSure Star appears to be a traditional medical device (blood glucose meter) rather than an AI-powered diagnostic system requiring a training phase in the AI sense.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. As mentioned above, this device does not appear to be an AI algorithm with a training set.
§ 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.