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The AG-6081 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.

The AG-6081 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-6081 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6081 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 Single meters and AGS-1100 Single test strips.

The AG-6951 Single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 Single Blood Glucose Monitoring System is to be used by a single person and should not be shared.

The AG-6951 Single Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AG-6951 Single Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 Single Blood Glucose Test Strips are for use with the AG-6951 Single Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 Single meters and AGS-1100 Single test strips.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

The AG-6081 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6081 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.

The AG-6081 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6081 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6081 MULTI meters and AGS-1100 MULTI test strips.

The AG-6951 MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The AG-6951 MULTI Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program.

The AG-6951 MULTI Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly).

The AGS-1100 MULTI Blood Glucose Test Strips are for use with the AG-6951 MULTI Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AGS-1100 Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the AG-6951 MULTI meters and AGS-1100 MULTI test strips.

This system contains a speaking function that provides audible test results for users with impaired vision. The audible function does not provide complete instructions for all functions of the meter or for performing a glucose test.

AG-6081 and AG-6951 Single Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.

While AG-6081 and AG-6951 MULTI Blood Glucose Monitoring System (BGMS) consist of blood glucose meter, MULT! use test strips, Auto-disabling Lancing device and the control solutions.

The four blood Glucose Monitoring system AG-6081 Single, AG-6951 Single, AG-6081 MULTI and AG-6951 MULTI are all based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. All of them use the same technological characteristics for testing with their predicate device. Only the appearance is different from their predicate device, and the new devices can test the blood glucose at the alternative site: the palm, the forearm, the upper arm, the calf and the thigh.

More over, AG-6951 Single and AG-6951 MULTI Blood Glucose Monitoring Systems have a voice function, which is also different from their predicate device.

This document describes the AG-6081 Single, AG-6081 MULTI, AG-6951 Single, and AG-6951 MULTI Blood Glucose Monitoring Systems (BGMS). These devices are intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The document focuses on comparing the new devices to a predicate device (AG-606 Blood Glucose Monitoring System, K073030) and claims conformity to relevant standards, but provides very limited details about the specific studies.

Here's an attempt to answer your questions based on the provided text, while acknowledging the severe limitations in the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the devices conform to the following standards:

• ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
• FDA Draft Guidance Document-Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems: October 24, 2006
• CLSI/NCCLS Guideline, EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second edition

However, the specific "acceptance criteria" (e.g., accuracy percentages, bias limits) from these standards and the "reported device performance" in relation to these criteria are not explicitly provided in the text. The document only states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," implying that the devices met the performance requirements referenced in these standards without detailing the actual results.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. There is no mention of the number of samples, participants, or the type of study (retrospective or prospective) used for performance evaluation. The country of origin of the data is also not specified, though the submitter is based in Tianjin, China.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The text does not detail any expert involvement in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader, multi-case comparative effectiveness study with human readers and AI assistance is not applicable to this type of medical device (blood glucose monitoring system). These devices are standalone measurement tools and do not involve human interpretation of complex images or data that AI would assist with in the usual sense of an MRMC study.

6. Standalone Performance Study

Based on the claim of conformity to ISO 15197 and FDA guidance for blood glucose monitoring systems, a standalone performance study would have been conducted. ISO 15197 specifies accuracy requirements for glucose meters, which are assessed by comparing meter readings to a reference method (e.g., laboratory analyzer). While the document states "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," the detailed results of such a standalone study are not explicitly presented.

7. Type of Ground Truth Used

For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., hexokinase method on a clinical chemistry analyzer) to measure blood glucose concentrations. The device's readings are then compared against these highly accurate reference values. This is implied by the nature of such devices and the standards cited, but not directly stated in the provided text.

8. Sample Size for the Training Set

This information is not applicable as blood glucose monitoring systems of this type (electrochemical biosensors) are not typically "trained" in the machine learning sense. Their performance is inherent to their design and manufacturing, rather than learned from a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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