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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-48cm.

Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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.

Here's a breakdown of the acceptance criteria and the study information for the "Fully Automatic Electronic Blood Pressure Monitor," based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The provided document states that the new device models (KD-5811A, KD-5811V, and KD-5815) have the same pressure and pulse rate accuracy as the predicate device (KD-5811, K210770). The predicate device's performance aligned with these criteria. The specific methods used to measure and verify these performances against the acceptance criteria are detailed in the study section.

Study Information

The document refers to a "clinical test report" for a previously cleared device (KD-5961, K083246) as a reference, stating that the subject devices (KD-5811A, KD-5811V, KD-5815) share the same algorithm and design principle. The acceptance criteria for accuracy were verified by meeting ISO 81060-2.

Here's the breakdown of the study details based on the provided text, recognizing that details for KD-5961 are referenced rather than presented explicitly for the current submission:

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

• Test Set Sample Size: Not explicitly stated for the referenced clinical test report of KD-5961 or for the current submission. The document only mentions that accuracy was verified by meeting ISO 81060-2 criteria.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

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

• Not specified. The ISO 81060-2 standard typically involves trained observers for reference measurements, but the exact number and qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

• Not specified. ISO 81060-2 outlines procedures for reference measurements and statistical analysis for accuracy, but specific adjudication methods like 2+1 or 3+1 are not mentioned.

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

• No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which typically implies standalone operation without human-in-the-loop assistance in the measurement itself. The comparison is between automated devices and a reference standard (likely auscultation) as per ISO 81060-2.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the reference device KD-5961, as implied by the statement: "Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." This standard specifically assesses the performance of automated non-invasive sphygmomanometers without human assistance.

7. Type of Ground Truth Used

• The ground truth used would be the reference measurements obtained through a validated method, as prescribed by ISO 81060-2. For blood pressure monitors, this typically involves simultaneously comparing the device's readings to those obtained by skilled observers using a standardized auscultatory method (e.g., mercury sphygmomanometer) on the same subjects.

8. Sample Size for the Training Set

• Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The "algorithm" mentioned (amplitude) refers to the computational method used to derive blood pressure values from oscillometric pulses.

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

• Not applicable, as there is no training set in the AI/ML context for this type of device. The device's "algorithm" (amplitude) is based on established oscillometric principles and likely calibrated during manufacturing based on engineering specifications and potentially clinical validation data.

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