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Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.

The Jawon Model HD-303S is a compact, automatic sphygmomanometer intended for measurement of blood pressure at the wrist. The method of operation is the oscillometric method. The control unit and the cuff are physically integrated into a single wrist-mounted unit. The system is microprocessor controlled and includes an air pump; fuzzy logic to regulate inflation, deflation, and measurement operations; circuitry to detect and process minute pressure oscillations; a six-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the previous eight measurement results; and two pushbutton controls.

Acceptance Criteria and Device Performance for Jawon Model HD-303S Noninvasive Blood Pressure Measurement System

This document outlines the acceptance criteria and the study that demonstrates the Jawon Model HD-303S Noninvasive Blood Pressure Measurement System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the Jawon Model HD-303S was evaluated against the ANSI/AAMI Standard SP10-1992. This standard sets the accuracy criteria for automated sphygmomanometers. While the specific numerical criteria for systolic and diastolic blood pressure accuracy are not explicitly listed in the submission, the summary confirms full compliance.

2. Sample Size and Data Provenance for the Test Set

The 510(k) summary explicitly states: "The measurement performance of the Jawon system has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992."

• Sample Size for Test Set: The exact number of subjects or measurements in the clinical studies is not specified in the provided text. ANSI/AAMI SP10-1992 typically requires a minimum of 85 subjects for clinical validation.
• Data Provenance: The country of origin of the data is implied to be Korea where Jawon Medical Co., Ltd. is located, but not explicitly stated. The studies are prospective clinical studies, as they were conducted to evaluate the device against a standard as part of its premarket submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

The 510(k) summary does not specify the number or qualifications of experts used to establish the ground truth for the test set. However, a clinical study conducted in accordance with ANSI/AAMI SP10-1992 would typically involve at least two trained observers (often physicians or trained technicians) for auscultatory reference measurements performed simultaneously for comparison with the automated device. These observers would be specifically trained and certified for blood pressure measurement according to the standard's requirements.

4. Adjudication Method for the Test Set

The 510(k) summary does not explicitly state the adjudication method used. However, for clinical validation against ANSI/AAMI SP10-1992, the standard prescribes a specific method for establishing reference blood pressure. This typically involves simultaneous auscultatory measurements by two trained observers, with agreement criteria between their readings. If there is significant disagreement, a third observer might be involved, or the measurement might be discarded. This aligns with a form of expert consensus, often a "2+1" model if a third adjudicator is needed for discrepancies.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or indicated. This type of study, comparing human readers with and without AI assistance, is not applicable to a standalone blood pressure monitor. The device is intended to provide a direct measurement, not to assist human interpretation of complex medical images or data that traditionally involve multiple human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The summary states, "The measurement performance of the Jawon system has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992 and found to comply fully with the accuracy criteria established in the standard." This refers to the algorithm-only performance of the device in measuring blood pressure.

7. Type of Ground Truth Used

The ground truth used for the clinical studies in accordance with ANSI/AAMI SP10-1992 is expert consensus auscultatory blood pressure measurements. In these studies, a trained observer (or multiple observers) uses a stethoscope and a mercury or aneroid sphygmomanometer as the reference standard to manually measure blood pressure. This manual measurement, often involving consensus between two observers, serves as the "truth" against which the automated device's readings are compared.

8. Sample Size for the Training Set

The 510(k) summary does not provide specific details about a separate "training set" sample size. The device uses "fuzzy logic to regulate inflation, deflation, and measurement operations" and "a pressure measurement algorithm designed to detect, filter, process, and store pressure readings." While such algorithms are typically developed and refined using data (a training set), the submission focuses on the clinical validation using a separate test set as required by ANSI/AAMI SP10. The training data would have been internal and proprietary during the device's development phase.

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

Similar to point 8, the 510(k) summary does not explicitly describe how the ground truth for any internal training set was established. However, for the development of a blood pressure measurement algorithm, the ground truth for training data would almost certainly be established through expert auscultatory blood pressure measurements on subjects, similar to the method used for the validation test set. This data would be used to refine and optimize the fuzzy logic and measurement algorithms to accurately correlate oscillating pressure waves with systolic and diastolic blood pressure.

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