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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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To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement. The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750). The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.

This 510(k) premarket notification (K071523) by GENEXEL-SEIN, INC. for the Full Auto Wrist Digital Blood Pressure Monitor (Models BP1600, BP1650, BP1700, and BP1750) references substantial equivalence to a predicate device (K012054) rather than providing specific acceptance criteria and a standalone study for the new device. The provided text indicates that the performance of the new device is "Identical" to the predicate device. Therefore, the details about acceptance criteria, specific performance metrics, and the study proving compliance are derived from the overall claim of substantial equivalence and the listed characteristics.

Given the information provided, a direct table of acceptance criteria with reported device performance of the new device in a standalone study is not explicitly present. The submission relies on the established safety and effectiveness of the predicate device.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the "Performance" of the new device is "Identical" to the predicate device (510(k) # K012054). Therefore, the implied acceptance criteria would be those met by the predicate device, and the reported performance is that it matches the predicate. Specific numerical criteria are not provided for the new device in isolation.

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

The document does not describe a new, separate clinical study with a test set conducted for this 510(k) submission (K071523). Instead, it claims substantial equivalence based on the technological characteristics being identical or similar to the predicate device. Details on sample size or data provenance for a test set for the new device are therefore not provided. It's implied that the predicate device would have undergone such testing.

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

As no specific test set study for K071523 is described, there's no information about the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

Since no specific test set study for K071523 is described, there's no information about an adjudication method.

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

No MRMC study is mentioned for this device. Blood pressure monitors typically do not involve multi-reader multi-case studies, as their function is to provide an objective measurement.

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

The document does not describe a standalone performance study for the K071523 device. The basis for clearance is substantial equivalence to a predicate device, meaning its performance characteristics are considered to be effectively the same as the predicate, which would have undergone performance validation. The device itself is an automated measurement system, so "algorithm only" performance would be synonymous with its standalone performance.

7. Type of Ground Truth Used

For blood pressure monitoring devices, the "ground truth" for accuracy studies typically involves comparison against a reference standard, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or an invasive arterial line. However, the document does not specify the ground truth method for this submission, instead relying on the predicate device's validation.

8. Sample Size for the Training Set

This submission does not discuss a training set, as it is not a machine learning or AI-based device in the common sense that would require a distinct training and test set with ground truth labeling for its development. It's a medical device with an oscillometric measurement algorithm.

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

Not applicable, as this device does not describe a machine learning training set in the context typically seen for AI/ML devices.

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