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Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 15 and above, in a home care environment.

Both models of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. All measurements are performed using the oscillometric method. The display unit and the measurement cuff are interconnected by tubing. Both models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitty to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and pushbutton controls. Model HD-2000F includes a memory function.

The provided 510(k) summary for the Jawon Medical Co., Ltd. Models HD-1000S and HD-2000F Noninvasive Blood Pressure Measurement System outlines the acceptance criteria and the study conducted to prove the device meets these criteria.

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document states "clinical studies" were conducted. However, it does not specify the exact sample size (number of patients or measurements) used for the clinical test set.
   • Regarding data provenance, the document does not explicitly state the country of origin or whether the studies were retrospective or prospective. However, clinical studies conducted for regulatory approval are almost always prospective.

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

   • The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical studies. For blood pressure monitors, ground truth often involves comparison to a reference standard method (e.g., auscultation by trained observers) rather than expert consensus on images.

3. Adjudication Method for the Test Set:

   • The document does not specify any adjudication method used for the test set. For blood pressure devices compliant with ANSI/AAMI SP10, the standard defines the methodology for comparison and statistical analysis against a reference method.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images. For a non-invasive blood pressure measurement system, the "reader" is the device itself, and the comparison is against an established reference measurement method.

5. Standalone Performance:

   • Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the primary measurement accuracy. The clinical studies evaluated the device's ability to measure blood pressure against a reference method. The device's operation is automatic and relies solely on its internal algorithm to determine blood pressure readings.

6. Type of Ground Truth Used:

   • The implied ground truth for the blood pressure measurement accuracy is comparison to a reference standard, likely auscultation. The ANSI/AAMI SP10-1992 standard typically dictates that the device's readings are compared against simultaneous measurements taken by trained observers using a validated reference method (e.g., mercurial sphygmomanometer with a stethoscope) to establish accuracy.

7. Sample Size for the Training Set:

   • The document does not provide information on the sample size used for any training set. This is a regulatory filing for a medical device; while algorithm training is a prerequisite, the filing focuses on the validation of the final device.

8. How the Ground Truth for the Training Set Was Established:

   • The document does not provide information on how the ground truth for any training set was established.

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