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The Easy2Check blood glucose and blood pressure monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8".

This system offers wireless communication function which is able to transmit the test result to other devices, such as PC.

PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor. The system measures glucose in fresh capillary whole blood and measures non-invasively the systolic and diastolic blood pressure and pulse rate. It has wireless communication function.

The provided document is an FDA 510(k) clearance letter for the "PMP Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor". It does not contain a detailed study description with specific acceptance criteria and performance data. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information is typically found in the 510(k) summary or the full 510(k) submission, which is not provided in these snippets. The document focuses on the FDA's regulatory decision, not on the detailed technical performance data of the device itself beyond its intended use.

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