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KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

KD-5917, KD-5915 and KD-5031 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is ,a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

It is designed and manufactured according to ANSI/AAMI SP10-manual, electronic or automated sphygmanometers.

The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-5917 is 60 times, the memory capability of KD-5915 is 2 X 60 times, the memory capability of KD-5031 is 3×30 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-5915 and KD-5031 also have the function of averaging the last three measurements, KD-5915 also has the voice function.

This submission pertains to the KD-5917, KD-5915, and KD-5031 Fully Automatic Electronic Blood Pressure Monitors. The primary study used to demonstrate effectiveness is the conformance to the AAMI SP10:2002 standard for sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary explicitly states that the devices conform to AAMI SP10:2002 in section 8.0 "Performance summary." This standard outlines the specific acceptance criteria for accuracy (mean difference and standard deviation of differences).

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

The 510(k) summary does not specify the sample size for the test set used to demonstrate conformance to AAMI SP10:2002. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). Conforming to AAMI SP10 typically involves a prospective clinical study with a specified number of subjects.

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

The 510(k) summary does not provide details on the number of experts used or their qualifications for establishing ground truth. For AAMI SP10, ground truth measurements are typically taken simultaneously by trained observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer with stethoscope).

4. Adjudication Method for the Test Set

The 510(k) summary does not describe an adjudication method. In the context of AAMI SP10, ground truth is typically established by multiple trained observers, and differences between their readings are addressed through a standardized protocol, often involving reconciliation or averaging. However, the exact method for this specific submission is not detailed.

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

The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. Blood pressure monitors are standalone measurement devices.

6. Standalone Performance

Yes, a standalone performance assessment was done. The conformance to the AAMI SP10:2002 standard is a standalone assessment of the device's accuracy and performance against an established reference without human-in-the-loop interaction for the measurement itself. The device is a "Fully Automatic Electronic Blood Pressure Monitor," implying its operation without continuous human interpretation during the measurement process.

7. Type of Ground Truth Used

The ground truth used for the AAMI SP10 standard typically involves simultaneous measurements by trained human observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer). This is a form of expert reference measurement, but not necessarily "expert consensus" in the sense of multiple experts independently reviewing and agreeing on a singular pathology.

8. Sample Size for the Training Set

The 510(k) summary does not provide information on a training set. For a blood pressure monitor, the algorithm for oscillometric measurement is typically developed and refined using a large dataset of pressure waveforms and corresponding auscultatory readings. This development process isn't usually described as a "training set" in the same way as for AI/ML algorithms. The 510(k) focuses on the validation of the final device.

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

Since no specific "training set" is described for this device, information on how its ground truth was established is not provided in the summary. However, in general, for oscillometric blood pressure monitors, the algorithms are developed using data where ground truth is established through simultaneous auscultatory measurements by trained personnel.

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