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KD-525E 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-30cm.

KD-525E Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data.

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

Acceptance Criteria and Device Performance Study (K070395)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not specified in the provided text. The document only mentions "Clinical tests were performed."
• Data Provenance: Not specified. It's not mentioned if the data was collected retrospectively or prospectively, nor the country of origin.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified. The document only states "Clinical tests were performed."
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. For blood pressure monitors, the "ground truth" is typically established by comparing the device's readings against a reference method (e.g., auscultation by trained observers) as outlined in standards like ANSI/AAMI SP10. The text does not detail the specific methodology used for establishing reference measurements or any adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this submission. This type of study is more relevant for diagnostic imaging AI systems where human interpretation is a key component. This device is a standalone blood pressure monitor.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, the described "Clinical tests" evaluate the standalone performance of the KD-525E Fully Automatic Electronic Blood Pressure Monitor. The device itself is an automated system; its performance directly reflects the algorithm's capability. The comparison is against the accuracy requirements of ANSI/AAMI SP10-2002.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for evaluating the accuracy of the blood pressure monitor would have been established using a reference measurement method as defined by the ANSI/AAMI SP10-2002 standard. This typically involves simultaneous or closely timed measurements by trained observers using a mercury sphygmomanometer (or another validated reference) via auscultation. The standard specifies statistical comparisons between the automated device readings and these reference measurements.

8. Sample Size for the Training Set

• Sample Size: Not applicable/not specified. As an oscillometric blood pressure monitor, this device likely uses a pre-programmed algorithm based on general physiological principles for measuring blood pressure, rather than "training" on a specific dataset in the way a modern AI/machine learning model would. Therefore, a "training set" in that context is not relevant.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable. For the reason stated above, there isn't a "training set" in the common AI/ML sense with associated ground truth for this type of device. The algorithm's development and validation would rely on established oscillometric principles and calibration against precise pressure measurements.

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