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This blood pressure monitor is designed to measure blood pressure (diastolic and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

The KOROT P3 Accurate is a digital monitor intended for use in measuring blood pressure and pulse rate in adults with upper arm circumference ranging from 22cm (9-inch to 20-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The KOROT P3 Accurate may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.

Blood pressure is the measurement of pressure of blood vessels. Blood vessels. Blood pressure can be measured by direct or indirect measurement supports indirect measurement using cuff. This equipment tracks and analyzes the blood flow oscillations under the pressure using the highest to the lowest pressure as shown by the figure below when the minute pressure speed is determined by the heartbeat. This equipment adopts Oscillometric method and automated auscultation method using a cuff for blood pressure measurement. In case of Oscilometric method, the device determines the systolic, diastolic and pulse rate on the blood flow oscillations measured through the cuff. On the other hands, in case of Auto auscultation method that combines the accuracy of auscultation, which is regarded as the gold standard for blood pressure measurement. To measure the blood pressure, wap the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the Korotkoff sound signal and the pressure sensor signal, which you can catch with the sensor attached to the cuff, to measure the systolic blood pressure. The Automated Auscultation applied to KOROT P3 Accurate combines the accuracy of the auscultation method staffs hear directly with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement.

Here's a detailed breakdown of the acceptance criteria and study information for the KOROT Blood Pressure Monitor (KOROT P3 Accurate), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KOROT P3 Accurate are aligned with the ISO 81060-2:2018 standard for non-invasive sphygmomanometers. The study aims to demonstrate that the device's measurements are within specified limits compared to a reference measurement.

Note on "Implied": The provided document is a 510(k) clearance letter and a summary. It confirms that "the totality of the clinical data...supported the device's claim of being applicable," indicating that the device met the performance requirements of ISO 81060-2:2018. However, the exact numerical performance values (e.g., mean difference and standard deviation) are not explicitly stated in this high-level summary. These details would typically be found in the full clinical study report submitted to the FDA.

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

• Sample Size:
  • The document mentions "additional clinical data were collected for the extra range of the upper arm circumference," specifically for the range of 42 to 52 cm.
  • It also states that "the totality of the clinical data from 22 to 52 cm supported the device's claim." This implies the original clinical data for 22-42 cm was combined with the new data.
  • The exact number of subjects for the additional test set (42-52 cm) is not specified.
  • The exact total number of subjects across the entire 22-52 cm range is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin).
• Retrospective or Prospective: Not explicitly stated, but clinical validation studies for medical devices are typically prospective to gather new data under controlled settings.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. For blood pressure monitor validation studies (like ISO 81060-2), ground truth is typically established by two trained observers using a reference sphygmomanometer (mercury sphygmomanometer or an equivalent standard) simultaneously, following very strict protocols for auscultation. While not explicitly stated here, it is standard practice for such studies.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. However, in studies validating blood pressure devices against a reference method (auscultation), the widely accepted standard involves:

• Two trained observers providing independent readings.
• If there's a significant discrepancy between the two observers' readings (e.g., > 4 mmHg), a third trained observer may be invoked, or the measurement might be discarded and re-taken. This is often referred to as a "2+1" or similar method, ensuring high accuracy for the ground truth.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
  • MRMC studies are typically for diagnostic imaging interpretation (e.g., radiologists interpreting images with and without AI assistance).
  • This device is a blood pressure monitor, and its validation involves comparing its numerical output to a reference standard (auscultation), not comparing interpretations by multiple human readers of complex cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was performed.
  • The KOROT P3 Accurate is a device that autonomously measures and reports blood pressure and pulse rate (using oscillometric and automated auscultation methods).
  • The clinical validation studies comparing its readings directly against a reference standard (human auscultation) are by definition standalone performance assessments of the device itself.
  • There is no "human-in-the-loop" AI interpretation component for this type of device.

7. Type of Ground Truth Used

The ground truth used for this device's validation is likely expert auscultatory measurements using a reference sphygmomanometer (e.g., mercury sphygmomanometer or a validated electronic reference device) according to the ISO 81060-2 standard. This is the gold standard for non-invasive blood pressure measurement validation.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" sample size. Blood pressure monitors often rely on established algorithms for oscillometric measurement, which might be developed using extensive physiological data, but this is distinct from "training data" in the machine learning sense for tasks like image classification. If the device uses adaptive algorithms that learn from patient data over time (unlikely for a basic BP monitor), that information is not disclosed here.

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

As no specific training set and its size are mentioned, the method for establishing its ground truth is also not provided. Given the nature of a blood pressure monitor, the core algorithms are likely based on well-established physiological models and signal processing, rather than a machine learning "training set" with ground truth in the typical AI context.

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