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KD-7920 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 wrist. The cuff circumference is limited to 14cm-25cm.

KD-7920 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

The provided text describes the submission of a 510(k) premarket notification for the "7920 Fully Automatic Electronic Blood Pressure Monitor." This document focuses on demonstrating that the new device is substantially equivalent to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-invasive blood pressure measurement system. The primary acceptance criteria for such a device are accuracy for systolic and diastolic blood pressure, and pulse rate. The document references compliance with ISO 81060-2 for clinical accuracy, which sets specific criteria for these measurements.

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

The document states that "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2."

• Sample Size for Test Set: The specific sample size for the clinical test set is not explicitly stated in the provided text. However, ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic distribution, often involving both sexes and different age/BP ranges) and a certain number of measurements per subject for statistical validity.
• Data Provenance: The document does not specify the country of origin for the clinical test data. It is also not explicitly stated whether the study was retrospective or prospective, but clinical investigations for device approval are typically prospective.

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

The document references ISO 81060-2 for clinical accuracy. In such studies, ground truth for blood pressure is typically established by at least two independent, trained observers (experts) using a standardized auscultatory method (e.g., mercury sphygmomanometer calibrated against a reference) and adhering strictly to established protocols.

• Number of Experts: ISO 81060-2 typically requires two trained observers.
• Qualifications of Experts: The standard requires observers to be appropriately trained and certified in the auscultatory technique, demonstrating proficiency and inter-observer reliability before participating in the study. While specific qualifications like "radiologist with 10 years of experience" are not relevant for blood pressure measurement, the emphasis is on rigorous training and demonstrated competency in the reference measurement method.

4. Adjudication Method for the Test Set

For clinical blood pressure validation studies according to ISO 81060-2, the adjudication method generally involves:

• Simultaneous measurements: The device and the two expert observers take measurements simultaneously or in very rapid succession.
• Blinding: The observers are typically blinded to each other's readings and often to the device's readings. The device is also "blinded" if possible (e.g., automated capture without immediate display to the subject).
• Comparison of observer readings: The two observers' readings are compared. If they differ by more than a pre-defined threshold (e.g., 4 mmHg for SBP/DBP), a third observer or a re-measurement/adjudication process might be triggered, or the data point might be discarded. This helps ensure the reliability of the reference standard.

The specific adjudication method (e.g., 2+1, 3+1) is not detailed in the provided text, but it would have followed the requirements of ISO 81060-2 which mandates stringent protocols for reference measurements.

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

• No MRMC comparative effectiveness study was done. This device is a fully automatic electronic blood pressure monitor, which does not involve human readers interpreting diagnostic images or data in the same way an AI-assisted diagnostic tool would. The performance is assessed in standalone mode against a reference standard.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was done. The clinical test described as "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2" is a standalone evaluation. This involved comparing the device's measurements directly against the auscultatory reference standard performed by trained observers, without any human-in-the-loop assistance for the device itself.

7. Type of Ground Truth Used

• The ground truth used for the clinical accuracy study was expert consensus auscultatory measurements. This method involves trained medical professionals (the two observers described in point 3) listening to Korotkoff sounds and recording the systolic and diastolic pressures, serving as the gold standard for non-invasive blood pressure measurement in validation studies.

8. Sample Size for the Training Set

• The document does not provide any information regarding a separate "training set" sample size. This type of medical device (an oscillometric blood pressure monitor) relies on an established algorithm (stated as "Amplitude (Same as K092510)") rather than requiring a continuously updated, large-scale machine learning training set in the way a modern AI diagnostic algorithm might. The algorithm would have been developed and refined using historical data, but the specific size of that foundational dataset is not mentioned or typically required for this type of submission.

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

• Similar to the above, information on how a "training set ground truth" was established is not provided. The device's algorithm is stated to be the same as the predicate device (K092510). This implies that the underlying algorithm was previously validated and established. The design principle is based on "oscillometric and silicon integrates pressure sensor technology," which uses physical principles and signal processing to derive blood pressure values, rather than being a learnable AI model from a labelled training dataset in the contemporary sense. Any initial development of such an algorithm would have involved comparisons to reference measurements, but specific details are not in this document.

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