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The DUO-CARE blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.

Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.

The system includes optional accessory software that is installed on the users' computers for data management purposes.

DUO-CARE Genexel-Sein Blood Glucose & Pressure Monitor system combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Genexel-Sein, Inc has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30 days. Control Solution is sold separately from the kit.

DUO-CARE adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

This 510(k) summary (K080853) is for a "BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL DUO-CARE." It describes a combined device for measuring blood glucose and blood pressure. The summary focuses on substantiating equivalence to a predicate device (K052108) rather than providing detailed acceptance criteria and study results for its own performance.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not available in the provided document. The document states "This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison," implying that the safety and effectiveness are established by demonstrating substantial equivalence to the predicate, rather than through a new, independent performance study with its own acceptance criteria detailed in this summary.

Here's the information that can be extracted or deduced from the provided text, with many fields explicitly marked as "Not provided" due to the nature of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states, "This device is safe and effective as the predicate device cited above." It does not provide specific acceptance criteria or performance numbers for the DUO-CARE device itself. The claim of safety and effectiveness relies on its "substantial equivalence" to the predicate device (K052108), meaning its performance characteristics are presumed to be similar enough to be considered safe and effective for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: Not provided.
• Data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. The summary describes a medical device, not an AI or image-based diagnostic system where expert ground truth interpretation of a test set would be a primary method of validation for this type of 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a direct measurement device (blood glucose and blood pressure monitor), not an AI-assisted diagnostic tool that would involve human "readers."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable for a combined blood glucose and blood pressure monitor in the context of this 510(k) submission. The device is intended for direct measurement. While it has optional software for data management, the primary "performance" is the measurement itself, which is inherently "standalone" in its function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated for the DUO-CARE device. For blood glucose and blood pressure monitors, ground truth is typically established by comparing device readings to a highly accurate laboratory reference method or a clinically validated reference device. This 510(k) relies on the substantial equivalence to a predicate device, which would have undergone such validation.

8. The sample size for the training set

• Not applicable. This is a measurement device, not an AI model requiring a training set in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable.

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