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The AG-608N single Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N single Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The AG-608N 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-608N 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-1000N single Test Strips are for use with the AG-608N single Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N single Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly and that you are doing the test correctly. These solutions contain a known range of glucose, as indicated on the bottles.

The AG-608N MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The AG-608N 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 diabetes control program. The system is only used with single-use lancing devices.

The AG-608N 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-1000N MULTI Test Strips are for use with the AG-608N MULTI Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh.

The AG-608N control solutions are intended for use with the AG-608N MULTI Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

AG-608N Single Blood Glucose Monitoring System and AG-608N MULTI Blood Glucose Monitoring System measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. Your meter measures the current, calculates the blood qlucose level, and displays the result. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

Here's an analysis of the AG-608N Single and AG-608N Multi Blood Glucose Monitoring System, focusing on its acceptance criteria and the study that proves its performance, based on the provided FDA 510(k) files:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the AG-608N Single and AG-608N MULTI Blood Glucose Monitoring System conforms to ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.

While the specific numeric acceptance criteria for bias, precision, and accuracy as defined by ISO 15197 are not explicitly detailed in the provided text, the standard itself outlines these requirements. For instance, the 2003 version of ISO 15197 (which would likely be applicable around the 2011 submission date) typically requires:

• Accuracy: For glucose concentrations < 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference value. For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L), at least 95% of results must be within ±20% of the reference value.
• Precision (repeatability/intermediate precision): Coefficients of variation (CVs) for within-day and between-day measurements should be within specified limits, generally less than 5% for higher glucose concentrations and within specified mg/dL values for lower concentrations.

The document doesn't provide the detailed reported performance data against these specific numeric criteria. It only states that "Non-clinical test and the clinical test are done according to the above standard." Without the actual performance tables, we cannot list the specific reported device performance values.

However, based on the statement that the device "conforms to" ISO 15197, we can infer that the device's performance met the general accuracy and precision requirements of that standard.

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

• Sample Size for Test Set: The document explicitly states that "Non-clinical test and the clinical test are done according to the above standard," referring to ISO 15197. However, it does not specify the sample size used for these tests. ISO 15197 typically mandates a minimum number of subjects (e.g., 100 for accuracy evaluation) and a specific number of blood samples over a range of glucose concentrations for evaluating performance claims. Without the detailed study report, the exact sample size is unknown from this document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the submitter's address (Tianjin, P.R. China), it is highly probable the studies were conducted in China. The statement about "clinical test" suggests a prospective study, but this is not explicitly confirmed.

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

• The document does not specify the number of experts used to establish ground truth or their qualifications.
• For blood glucose monitoring systems, the "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) operated by trained laboratory personnel, rather than clinical experts for individual measurements. While these personnel are experts in operating the reference method, they are not medical experts in the sense of a radiologist interpreting images.

4. Adjudication Method for the Test Set:

• The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the performance evaluation of a blood glucose monitoring system where the ground truth is established by a quantitative laboratory reference method. The reference method provides a definitive numerical value, eliminating the need for expert consensus or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. MRMC studies are typically employed for diagnostic imaging devices where human interpretation plays a significant role and the AI's impact on human performance is being assessed.
• This device is a standalone in vitro diagnostic system for direct glucose measurement. Its performance is evaluated against a laboratory reference method, not in conjunction with human readers or interpreters in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes, a standalone performance study was done. The entire evaluation of the AG-608N system, as described by its conformity to ISO 15197, inherently involves testing the device's accuracy and precision as a standalone unit. The system measures glucose and displays a result directly; there is no "human-in-the-loop" interpretation in the measurement process itself, beyond physically performing the test. The "clinical test" refers to testing the device on actual patient samples, with the device running as an algorithm only to produce results compared to a reference standard.

7. The Type of Ground Truth Used:

• The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., a YSI Glucose Analyzer). This method is considered the gold standard for accurately measuring glucose concentration in blood samples. While not explicitly stated as "YSI," the adherence to ISO 15197 implies such a high-accuracy laboratory method was used.

8. The Sample Size for the Training Set:

• The document does not provide any information regarding a training set sample size. Blood glucose monitoring systems like the AG-608N generally operate on electrochemical principles rather than machine learning algorithms that require a distinct training phase in the same way an AI image analysis system would. Therefore, the concept of a "training set" for the device's core measurement algorithm is likely not applicable in the same context. Any "training" would be related to calibration and quality control during manufacturing.

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

• As a training set in the AI/machine learning sense is not applicable, the question of how ground truth for it was established is also not applicable. The device's fundamental operational parameters and calibration are established through rigorous quality control procedures and calibrations against certified glucose standards, not through a "training set" of patient data.

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