Search Results

The WaveSense 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 of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.

The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The provided text describes a 510(k) premarket notification for the WaveSense Jazz Blood Glucose Monitoring System. The document focuses on establishing substantial equivalence to a predicate device (K072413), rather than presenting a de novo clinical study with detailed acceptance criteria and performance data as typically seen for novel devices, especially those incorporating AI.

Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving device performance (especially for an AI/ML context) is largely absent from this specific 510(k) summary. The document primarily discusses the intended use, technological comparison to a predicate, and the modifications made (new colors, new data management feature), implying that much of the performance data would have been established for the original predicate device.

However, I can extract the relevant information that is present and indicate where information is not available from the provided text.

Here's an attempt to answer based on the provided document, acknowledging its limitations for an AI/ML-centric request:

Acceptance Criteria and Device Performance (based on the provided 510(k) Summary for a Glucose Monitoring System)

It's crucial to understand that this 510(k) pertains to a Blood Glucose Monitoring System, which is a hardware-based diagnostic device, not an AI/ML-powered software or imaging device. Therefore, many of the typical questions regarding AI/ML clinical studies (MRMC, expert consensus for ground truth, training set details, etc.) are not applicable to this type of submission.

The "study" referenced in the provided text is primarily focused on verification and validation (V&V) of the modifications made to an existing predicate device, rather than a large-scale clinical trial to establish novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

For a Blood Glucose Monitoring System, acceptance criteria usually relate to accuracy standards (e.g., ISO 15197 for point-of-care testing), precision, and other analytical performance characteristics. The provided 510(k) summary does not explicitly list these numerical acceptance criteria or the specific performance results in a table. It instead states that "verification and validation results" were sufficient to establish substantial equivalence.

However, based on typical FDA requirements for Blood Glucose Monitoring Systems, the implicit acceptance criteria would relate to:

Ask a specific question about this device

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 JAZZ™ 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 WaveSense JAZZ™ 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 provided text is a 510(k) Summary for the AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System, dated August 17, 2007. It states the device's intended use and that it complies with ISO 15197:2003, but it does not contain information about specific acceptance criteria or a study proving the device directly meets acceptance criteria for accuracy with detailed performance metrics.

The document discusses the device's modification (no coding required), intended use, and compliance with various international standards, including ISO 15197:2003 ("In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus"). While compliance with ISO 15197 generally implies meeting certain accuracy standards, the specific performance data (e.g., mean absolute relative difference (MARD), percentages within certain error grids) are not present in this summary.

Therefore, I cannot fulfill all parts of your request based solely on the provided text.

Here's what I can provide based on the given information, along with explanations for the missing elements:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document states compliance with ISO 15197:2003. This standard sets performance requirements for blood glucose monitoring systems.
  • ISO 15197:2003 Acceptance Criteria (generally, not explicitly stated in the document, but implied by compliance):
    • For glucose concentrations

Ask a specific question about this device

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).

Ask a specific question about this device