(78 days)
The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.
The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.
The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.
The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
The quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.
Here's an analysis of the On Call Vivid Pro Blood Glucose Monitoring System's acceptance criteria and the study proving it meets them, based on the provided text:
Acceptance Criteria and Device Performance for On Call Vivid Pro Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the device's accuracy was evaluated against the requirements of EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."
The key performance criterion mentioned in the conclusion is "accuracy requirements per EN ISO 15197". While the document doesn't explicitly list the detailed accuracy thresholds from this standard, it states that the system meets these requirements.
Table: Acceptance Criteria (Referenced Standard) and Device Performance (Study Conclusion)
| Performance Metric | Acceptance Criteria (from EN ISO 15197:2003) | Reported Device Performance |
|---|---|---|
| Accuracy | Meets requirements of EN ISO 15197:2003 | Meets the accuracy requirements per EN ISO 15197 and is comparable to a YSI Model 2300 STAT PLUS reference. It demonstrated comparable blood glucose readings between lay persons and trained laboratory technicians. |
Note: The specific numerical accuracy criteria (e.g., error grid analysis outcomes, percentage of results within a certain margin of a reference method) for EN ISO 15197:2003 are not provided in this summary but are the underlying benchmark mentioned.
Other performance characteristics evaluated as part of non-clinical tests (though specific acceptance values aren't typically stated as "acceptance criteria" but rather as "specifications" for these types of devices in 510k summaries):
- Repeatability precision
- Intermediate precision
- Linearity
- Interfering agents
- Hematocrit effect
- Temperature effect evaluation (blood & control solution)
- Low battery effect
- Altitude effect
- Sample volume
- Humidity effect
- Simulated shipping study (test strip & control solution)
- Control value assignment
- Meter testing
- Software validation testing
- Electromagnetic compatibility and electrical safety testing
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Tests: The document states "Clinical studies were conducted with lay persons and trained laboratory technicians". It does not specify the exact number of participants (sample size) for these clinical studies.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, as it's a 510(k) submission to the US FDA, and the company is based in San Diego, California, it's highly probable the clinical studies were conducted in the United States. The study is prospective, as it explicitly mentions "Clinical studies were conducted" to evaluate the system's accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Reference Method: The ground truth was established by the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade reference instrument for glucose measurement, widely considered a "gold standard" in blood glucose monitoring studies.
- Number of "Experts" for Ground Truth: While the YSI 2300 STAT PLUS is an automated instrument, its operation and validation would typically be performed by trained laboratory technicians. The document implicitly refers to these "trained laboratory technicians" as performing the reference measurements, stating "compared to the YSI Model 2300 STAT PLUS... per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System." The number of these technicians isn't specified, but their qualification is "trained laboratory technicians."
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned. The comparison is directly between the result from the On Call Vivid Pro system and the established reference device (YSI Model 2300 STAT PLUS).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a typical MRMC comparative effectiveness study, as understood in the context of radiology or image interpretation where human readers interpret cases with and without AI assistance, was not conducted.
- Instead, this study compared the device's performance against a reference standard (YSI Model 2300 STAT PLUS) and evaluated the comparable results between "lay persons" (users of the device) and "trained laboratory technicians" (who often run the reference method). The focus was on the device's accuracy and ease of use for its intended users, not on improving human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the accuracy study comparing the On Call Vivid Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS effectively represents a standalone performance evaluation of the device.
- The device, an electrochemical enzymatic assay, inherently provides an algorithmic output (the glucose reading) based on the electrochemical reaction on the test strip and the meter's calculation. Its performance is assessed independently of further human interpretation or intervention to correct its reading beyond its basic operation. The study evaluated "the system accuracy of the On Call Vivid Pro Blood Glucose Monitoring System."
7. Type of Ground Truth Used
- The ground truth used was a reference laboratory instrument's measurement (YSI Model 2300 STAT PLUS). This is a highly accurate and established method for quantifiable analyte measurement.
8. Sample Size for the Training Set
- The document does not specify a separate "training set" sample size or discuss how a training set was used. For a blood glucose monitoring system like this, the "development" or "training" of the system would typically involve extensive engineering, chemical formulation, and calibration efforts during the design phase, rather than a distinct "training set" of patient data as might be seen for AI/ML algorithms that learn from data. The clinical studies described are for validation (test set), not training.
9. How the Ground Truth for the Training Set Was Established
- Given that a specific "training set" for an AI/ML algorithm isn't described for this device, a method for establishing its ground truth is not applicable in this context. The development of the system's internal algorithms (e.g., for converting electrical current to glucose concentration) would be based on fundamental electrochemical principles, extensive laboratory testing with known glucose concentrations, and calibration against reference methods during the device's engineering and manufacturing process.
§ 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.