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The Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System / Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, 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 this system 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,

Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system consists of a monitor 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.

The system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8" (24 ~35 cm) for am.

Above systems offer wireless communication function which is able to transfer the test result to other devices, such as PC.

Here's a breakdown of the acceptance criteria and study information for the Clever Chek TD-3250C / TD-3250D / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System, extracted from the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical "acceptance criteria" for the blood glucose or blood pressure measurements in a table format with corresponding "reported device performance." Instead, it generally states that "The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use" and "Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system demonstrate satisfactory performance and are suitable for their intended use."

However, for similar devices, the FDA typically requires performance standards for glucose meters to establish accuracy within certain limits compared to a reference method (e.g., ISO 15197 standards for blood glucose monitoring systems). For blood pressure monitors, accuracy is usually assessed against a reference standard or by comparison with a sphygmomanometer against established protocols (e.g., AAMI, BHS, ESH protocols).

Given the lack of specific numerical criteria and performance data in this summary, it's not possible to generate the requested table directly from the provided text. The submission relies on the general finding of "satisfactory performance" to demonstrate substantial equivalence to the predicate device.

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

• Blood Glucose:

  • Sample Size: Not specified in the provided text. The document only mentions "clinical settings by healthcare professionals and lay users."
  • Data Provenance: Not explicitly stated. The submitter is TaiDoc Technology Corporation from Taiwan, but the location of the clinical studies is not mentioned. The studies are referred to generally as being "in the laboratory and in clinical settings." It is not specified if the studies were retrospective or prospective.

• Blood Pressure:

  • Sample Size: Not specified in the provided text. The document only mentions "clinical settings by healthcare professionals and lay users."
  • Data Provenance: Not explicitly stated. Similar to the blood glucose analysis, the location of the studies is not specified, nor whether they were retrospective or prospective.

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

This information is not provided in the 510(k) summary. The document does not detail how the ground truth for either glucose or blood pressure measurements was established, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

• Was it done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically done for diagnostic imaging devices where human readers interpret images, sometimes with and without AI assistance. The described device is a blood glucose and blood pressure monitoring system, which does not involve human interpretation of complex data in the same way.
• Effect Size of AI vs. absence of AI: Not applicable, as no such study was performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device itself is a standalone measurement system (meter and strips for glucose, cuff and monitor for blood pressure). The performance studies mentioned (in laboratory and clinical settings) inherently assess the algorithm's performance in generating the readings. However, the summary does not explicitly define a "standalone study" in the context of an AI algorithm separate from the device's operational use, as the device's core function is to produce quantitative measurements directly. The studies were designed to evaluate the system's accuracy in direct measurement.

7. Type of Ground Truth Used

The specific type of ground truth used is not explicitly stated in the summary. For blood glucose monitoring systems, ground truth is typically established using laboratory reference methods (e.g., YSI glucose analyzer). For blood pressure monitors, ground truth is usually established via a validated sphygmomanometer or another accepted reference standard. Since the summary only mentions "performance studies" and "clinical settings," it's implied that some form of comparative or reference measurement was used, but the specifics are absent.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document describes the device's technology but does not discuss machine learning or AI models with distinct "training sets" in the context of their development. The device relies on electrochemical and oscillometric methods, which are established physical measurement principles, not typically "trained" in the same way an AI algorithm designed for image interpretation would be.

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

This information is not provided as the concept of a "training set" in the context of an AI algorithm is not discussed for this device.

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