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510(k) Data Aggregation
(41 days)
AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. The meter is a portable, battery-operated instrument.
The provided text describes the AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System, which states that it complies with ISO 15197:2003. This standard specifies the requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. While the summary states compliance, it does not explicitly provide a table of acceptance criteria or reported device performance against specific targets from ISO 15197. Therefore, the following information is based on the general understanding of ISO 15197 for blood glucose meters, as the specific performance data is not detailed in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
As specific performance data against ISO 15197:2003 criteria is not provided in the document, a general representation based on the standard's requirements for accuracy is used.
| Performance Characteristic | Acceptance Criteria (from ISO 15197:2003 for glucose values ≥ 4.2 mmol/L (75 mg/dL) and < 4.2 mmol/L (75 mg/dL)) | Reported Device Performance |
|---|---|---|
| Accuracy (System) | For glucose values ≥ 4.2 mmol/L (75 mg/dL):- 95% of all measured glucose values shall fall within ±20% of the YSI reference measurement.For glucose values < 4.2 mmol/L (75 mg/dL):- 95% of all measured glucose values shall fall within ± 0.83 mmol/L (± 15 mg/dL) of the YSI reference measurement. | Stated to comply with ISO 15197:2003. (Specific data not provided in the document) |
| Precision (Repeatability) | Coefficient of variation (CV) ≤ 5% for glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), and standard deviation (SD) ≤ 0.28 mmol/L (5 mg/dL) for glucose concentrations < 4.2 mmol/L (75 mg/dL). | Stated to comply with ISO 15197:2003. (Specific data not provided in the document) |
2. Sample Size Used for the Test Set and Data Provenance
The document states compliance with ISO 15197:2003, which typically requires a minimum number of subjects and blood samples for accuracy evaluation. However, the exact sample size used for the test set in the study confirming compliance and the data provenance (e.g., country of origin, retrospective or prospective) are not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. For blood glucose monitoring systems, ground truth is typically established by a laboratory reference method (e.g., YSI analyzer) operated by trained laboratory personnel, rather than expert clinicians.
4. Adjudication Method for the Test Set
Not applicable. For blood glucose meter accuracy studies, ground truth is typically a reference laboratory measurement, not subject to clinical adjudication.
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
Not applicable. This is a blood glucose monitoring system, which does not involve human readers interpreting medical images or data that would typically be evaluated in an MRMC study with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a standalone blood glucose monitoring system. Its performance is evaluated intrinsically, meaning the system's output (blood glucose reading) is directly compared to a reference method, without human intervention as an interpretive step.
7. The Type of Ground Truth Used
Based on the nature of blood glucose monitoring systems and the reference to ISO 15197, the ground truth used for evaluating device performance would be laboratory reference measurements, typically from a highly accurate and precise instrument like a YSI glucose analyzer, applied to the same blood samples as tested by the device.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. Blood glucose meters are typically calibrated during manufacturing rather than "trained" with data in the way an AI algorithm would be. The design and manufacturing process would be validated against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of machine learning for an algorithm is not relevant to this type of device. Calibration and validation for blood glucose meters rely on precisely prepared glucose solutions and comparison to reference methods.
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