(121 days)
The Prodigy Voice 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.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prodigy Voice 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.
This system contains speaker function which provides step by step instructions.
The provided text offers minimal details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The studies demonstrated that the performance of this system meets its intended use." However, it does not provide specific acceptance criteria (e.g., accuracy percentages, precision metrics, bias limits) nor detailed performance results to populate such a table.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." There is no mention of the country of origin or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not specified. The document only mentions "healthcare professionals" conducted studies.
4. Adjudication Method for the Test Set:
Not specified.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not mentioned or implied. The focus appears to be on the device's standalone performance rather than comparing human readers with and without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):
Yes, this was undoubtedly done. The "Performance Studies" section states, "The performance of Prodigy Voice Blood Glucose Monitoring System was studied in the laboratory and in clinical settings..." This implies the device was tested as a standalone system.
7. Type of Ground Truth Used:
While not explicitly stated, for a blood glucose monitoring system, the ground truth would typically be established by a reference method (e.g., a laboratory-grade blood glucose analyzer that is traceable to an international standard). The text mentions "quantitative measurement of glucose," which necessitates a highly accurate reference for comparison.
8. Sample Size for the Training Set:
Not specified.
9. How the Ground Truth for the Training Set Was Established:
Not specified.
Summary of Available Information from the Provided Text:
| Feature | Details from the Text |
|---|---|
| Acceptance Criteria & Reported Performance | - Acceptance Criteria: NOT SPECIFIED. The document only states "The studies demonstrated that the performance of this system meets its intended use." |
- Reported Device Performance: NOT DETAILED. No specific metrics (e.g., accuracy, precision) or numerical results are provided. |
| Test Set Sample Size | NOT SPECIFIED. |
| Data Provenance (Test Set) | "in the laboratory and in clinical settings by healthcare professionals and lay users." - Country of Origin: Not specified.
- Retrospective/Prospective: Not specified. |
| Number & Qualifications of Experts (Ground Truth - Test Set) | NOT SPECIFIED. Mentions "healthcare professionals" but no details on number, specialties, or experience. |
| Adjudication Method (Test Set) | NOT SPECIFIED. |
| MRMC Comparative Effectiveness Study | NO. Not mentioned or implied. |
| Standalone Performance | YES. Implied by "Performance Studies... in the laboratory and in clinical settings." |
| Type of Ground Truth Used | Reference Method (e.g., laboratory-grade glucose analyzer). While not explicitly named, the nature of glucose measurement requires a highly accurate and precise reference method for comparative ground truth. |
| Training Set Sample Size | NOT SPECIFIED. |
| How Ground Truth for Training Set Was Established | NOT SPECIFIED. |
Conclusion:
The provided 510(k) summary (a premarket notification for demonstrating substantial equivalence to a predicate device) is high-level. It confirms that performance studies were conducted and that the device met its intended use, which is sufficient for 510(k) clearance. However, it does not provide the detailed scientific and clinical evidence, including specific acceptance criteria, performance metrics, sample sizes, or ground truth methodologies that would typically be contained in the full submission to the FDA. The purpose of this summary is to briefly introduce the device and its regulatory status, not to serve as a comprehensive research paper.
§ 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.