(90 days)
AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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.
AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. 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.
AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. 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.
AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.
The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately.
It is intended for over-the counter home use by diabetics to monitor their blood glucose levels or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.
The provided document describes a 510(k) summary for the AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System. The modification pertains to the wireless upload of glucose readings; therefore, the core performance of the glucose measurement itself likely relies on previously established data or adherence to recognized standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the manufacturer certifies the device complies with ISO 15197:2003 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus." This standard outlines performance requirements for blood glucose meters.
While the document states compliance with ISO 15197:2003, it does not provide a specific table of acceptance criteria from ISO 15197 or the detailed reported device performance against those criteria. It merely makes a general declaration of compliance. To fully answer this, the specific ISO 15197:2003 criteria (e.g., accuracy within certain percentage or mg/dL for different glucose ranges) and the AgaMatrix Jazz Wireless™ device's performance data against those criteria would be needed, but they are not included in this document.
What is present in the document:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| ISO 15197:2003 Compliance | Device certified to comply with ISO 15197:2003. (Specific numerical criteria and performance data are not provided in this document.) |
| Intended Use Performance | "The system performs as intended and raises no new safety of effectiveness issues." |
| Technological Characteristics | "Has the same intended uses, with similar technological characteristics as the predicate device." |
| Risk Management | Complies with ISO 14971:2000. |
| Electrical Safety | Complies with IEC 61010-1 and IEC 61010-2-101. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 61000-4-3. |
2. Sample size used for the test set and the data provenance
The document states "Based upon the testing and comparison to the predicate device". However, it does not specify the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way image analysis or clinical diagnosis might use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for a test set.
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
This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document indicates that the device itself performs the measurement. The "testing" mentioned implies standalone performance studies were conducted to demonstrate compliance with ISO 15197:2003. However, specific details of such standalone testing (e.g., protocol, metrics, results) are not provided, beyond the general statement of compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer). The document does not explicitly state the type of ground truth used, but this is the standard practice for demonstrating accuracy of blood glucose meters against a known, highly accurate method.
8. The sample size for the training set
The document does not provide any information about a "training set." This term is typically associated with machine learning or AI algorithms. While the device likely has internal algorithms for glucose measurement, the document does not discuss a separate training phase or associated sample sizes.
9. How the ground truth for the training set was established
As no training set is discussed, no information is provided on how its ground truth might have been established.
§ 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.