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KD-5905 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-5905 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 irreqular heartbeat is detected, it can be shown on the LCD. The RCC (radio controlled clock) function can automatically receive the radio clock signal to adjust the clock accurately.

Acceptance Criteria and Study Details for Andon Health Co., Ltd. KD-5905 Fully Automatic Electronic Blood Pressure Monitor

The provided document describes the KD-5905 Fully Automatic Electronic Blood Pressure Monitor, which is substantially equivalent to the KD-5902. The performance summary explicitly states that the KD-5905 monitor conforms to the AAMI SP10:2002 standard for manual, electronic, or automated sphygmomanometers, including its amendments.

1. Acceptance Criteria and Reported Device Performance

The general acceptance criteria for blood pressure monitors, as per ANSI/AAMI SP10, typically involve a comparison of the device's readings against a reference method (e.g., auscultation by trained observers). The standard specifies accuracy requirements for both systolic and diastolic blood pressure measurements.

While the document states conformance to AAMI SP10, it does not explicitly list specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) or the precise reported device performance results from an accuracy study. The document only mentions that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."

Hypothesized Acceptance Criteria (based on common AAMI SP10 requirements):

Since the document states conformance to the AAMI SP10 standard, it implies that the device successfully met these types of criteria during its testing. However, the specific numerical results are not provided in this summary.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the sample size (number of subjects) used for the performance testing that demonstrated conformance to AAMI SP10.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that "Andon Health Co., Ltd." is located in Tianjin, P.R. China, it is plausible that the testing was conducted in China. The nature of performance testing for blood pressure monitors is typically prospective, as it involves taking active measurements from subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

For blood pressure monitor validation studies conforming to AAMI SP10, the ground truth (reference measurements) is established by human observers using a standardized method (e.g., auscultation with a mercury sphygmomanometer).

• Number of Experts: AAMI SP10 usually requires at least two independent trained observers for simultaneous auscultatory measurements to establish the reference values.
• Qualifications of Experts: These observers typically need to be trained medical professionals (e.g., physicians, nurses, or trained technicians) who have demonstrated proficiency in taking blood pressure measurements according to standardized protocols and who are blinded to the device's readings. The document does not explicitly state the number or qualifications of the experts who established the ground truth.

4. Adjudication Method (Test Set)

• Adjudication Method: For AAMI SP10-compliant studies, the reference blood pressure is typically determined by taking the average of the two trained observers' readings, provided they are within a specified agreement range (e.g., 4 mmHg for systolic and diastolic). If their readings differ significantly, a third observer or a predefined adjudication process might be used, but the document does not explicitly describe the adjudication method beyond conforming to the AAMI SP10 standard. Based on AAMI SP10, it's typically a consensus or averaging of two observers.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this summary. This type of study is more common for diagnostic imaging AI systems and is not typically relevant for standalone blood pressure monitors. The device is intended for direct measurement rather than aiding human interpretation or diagnosis of complex cases.

6. Standalone Performance Study

• Standalone Study: Yes, the described performance testing (conformance to AAMI SP10) constitutes a standalone performance study of the algorithm and device. The device itself (KD-5905) directly measures and displays blood pressure and pulse rate without requiring human interpretation or intervention in the measurement process. The AAMI SP10 standard assesses the accuracy of the device's output against a reference method, which is a standalone evaluation of the device's performance.

7. Type of Ground Truth Used

• Ground Truth Type: The ground truth used for blood pressure monitor validation studies adhering to AAMI SP10 is expert auscultation (expert consensus). This involves simultaneous measurements taken by trained human observers using a validated reference method (e.g., a mercury sphygmomanometer).

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Blood pressure monitors based on oscillometric principles are typically designed and calibrated based on physiological models and empirical data, but they don't usually involve "training sets" in the same way as machine learning algorithms that learn from labeled data. The core technology and algorithms are established during product development, prior to formal regulatory performance testing.

9. How Ground Truth for Training Set Was Established

As there is no explicit training set mentioned or implied for this type of device, the method for establishing its ground truth is not applicable in the context of this document. The device's underlying algorithms are developed and refined during R&D based on engineering principles and general physiological data, not typically through a formal "training set" with established ground truth in the context of a regulatory submission.

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