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KD-556 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.

KD-556 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. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 2×60 times. If any irregular heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.

The KD-556 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. This standard sets forth the accuracy requirements for such devices.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the KD-556 conforms to the AAMI SP10 standard, which implies that a study was conducted according to the standard's requirements. These requirements would typically specify sample sizes for clinical validation.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. For blood pressure monitors, ground truth is typically established by trained technicians using a reference sphygmomanometer (e.g., mercury sphygmomanometer) following a specific protocol outlined in standards like AAMI SP10.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. In the context of blood pressure monitor validation, "adjudication" in the sense of expert consensus for image interpretation is not directly applicable. Instead, the validation involves direct comparison of the device's readings against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and it is not applicable for this type of device. The KD-556 is a standalone blood pressure monitoring device; its performance is measured against a reference standard, not against human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was implicitly done. The document states that the device "conforms to the following standards: AAMI SP10:2002, A1:2003, and A2:2006." The AAMI SP10 standard outlines rigorous clinical validation protocols for automated sphygmomanometers, which inherently involve testing the device's accuracy without human intervention influencing the measurement process itself beyond proper application.

7. The Type of Ground Truth Used

The ground truth used for blood pressure monitors following the AAMI SP10 standard is typically a reference measurement obtained by trained observers using a directly auscultated sphygmomanometer (e.g., mercury sphygmomanometer) or an equivalent validated reference device. This involves simultaneous or near-simultaneous measurements by the test device and the reference device on research subjects.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. For a device like a blood pressure monitor, the "training set" concept is usually associated with machine learning algorithms. While the device uses an "oscillometric and silicon integrate pressure sensor technology," it's likely pre-calibrated and validated against established standards rather than being "trained" in the typical AI sense.

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

As no training set is mentioned in the provided text, the method for establishing its ground truth is not applicable or provided. The accuracy of this device is primarily established through its adherence to the AAMI SP10 standard, which governs the clinical validation process.

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