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AgaMatrix JAZZ™ 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.

AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZTM Blood Glucose Test Strips 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.

AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter 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.

AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix JazzTM 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.

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 AgaMatrix Jazz™ Blood Glucose Monitoring System is certified to comply with ISO 15197:2003, which sets out criteria for in vitro diagnostic test systems for blood glucose monitoring for self-testing in managing diabetes mellitus. The 510(k) summary provided does not explicitly state specific acceptance criteria values (e.g., accuracy percentages) or the device's reported performance against such criteria in a table format. It states that the device "performs as intended and raises no new safety or effectiveness issues," implying it meets the standards of ISO 15197:2003 and is comparable to a predicate device.

Here is the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to compliance with ISO 15197:2003 as the primary standard for performance. However, specific numerical acceptance criteria (e.g., accuracy percentages within a certain range) and the device's reported performance against these criteria are not explicitly detailed in the provided text. The submission states: "The manufacturer of the Jazz™ Blood Glucose Monitoring System certifies that the device complies with the following: ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus."

Without further details from the full ISO 15197:2003 document or a more detailed performance summary, a specific table cannot be generated.

2. Sample size used for the test set and the data provenance:
Not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (blood glucose monitoring system). Ground truth is typically established through reference laboratory methods.

4. Adjudication method for the test set:
Not applicable.

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 standalone diagnostic device, not an AI-assisted interpretation system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the device is a standalone blood glucose monitoring system, and its performance would have been evaluated independently.

7. The type of ground truth used:
While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established using a reference laboratory method (e.g., a YSI analyzer) to measure blood glucose levels.

8. The sample size for the training set:
Not applicable for this type of device. The system likely uses fixed algorithms and calibration rather than a machine learning model that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable (as there's no stated training set for a machine learning algorithm).

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