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The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

The CLEVER CHEK TD-3250™ blood glucose and blood pressure measurement system consists of a meter with arm cuff and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. Also, the system adopts the "oscillometric method" to as the measuring principle and provides the measurement of the systolic and diastolic blood pressure and heart rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the . The pressure sensor converts tiny alterations in arm cuff pressure to electrical signals, by analyzing those signals to determine the systolic and diastolic blood pressure and calculating pulse rate.

The provided 510(k) summary for the CLEVER CHEK TD-3250™ system describes performance studies in general terms ("The performance of the CLEVER CHEK TD-3250™ system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the CLEVER CHEK TD-3250™ system is suitable for its intended use."). However, it does not explicitly state specific acceptance criteria or provide detailed quantitative results from studies that prove the device meets these criteria.

Therefore, I cannot populate all sections of your request with specific details. Based on the information available, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified.
• Data Provenance: Studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." The country of origin is not explicitly stated for these studies, but the manufacturer is based in Taiwan.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size information regarding human readers with or without AI assistance. The device is a diagnostic system, not an AI-assisted diagnostic aid for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, the performance studies implicitly refer to the standalone performance of the device ("The performance of the CLEVER CHEK TD-3250™ system was studied..."). However, no specific details or results from these standalone tests are provided beyond a general statement of suitability.

7. The Type of Ground Truth Used

• Ground Truth Type: Not specified. For blood glucose, ground truth typically involves a laboratory reference method. For blood pressure, it typically involves a validated reference sphygmomanometer reading. These methods are not explicitly stated.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is described as utilizing an electrochemical method and an oscillometric method. There is no indication that it is an AI/machine learning-based device that would require a "training set" in the conventional sense.

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

• Ground Truth for Training Set: Not applicable (as above).

Summary of what is known:

• Device Type: Blood Glucose and Blood Pressure Measurement System.
• Measurement Methods: Electrochemical for glucose, oscillometric for blood pressure.
• Studies Conducted: "Laboratory and clinical settings by healthcare professionals and lay users."
• Overall Conclusion: "The CLEVER CHEK TD-3250™ system demonstrates satisfactory performance and is suitable for their intended uses."

Summary of what is NOT known from the provided text:

• Specific quantitative acceptance criteria for either blood glucose or blood pressure.
• Specific quantitative performance results (e.g., accuracy, precision, bias).
• Sample sizes for any of the studies.
• Details about the experts or ground truth establishment methods.
• Any information regarding AI/machine learning training sets or human-in-the-loop studies.

To get the specific details requested in your prompt, one would need to refer to the full 510(k) submission document, which often contains detailed study protocols and results in appendices. The provided "510(k) Summary" is, by nature, a high-level overview.

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