(28 days)
Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with arm circumference of 22- 42cm.
The Arm-Type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-35, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension. Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-35 will display an irregular heartbeat symbol " (♥) " if an irregular heartbeat was detected during the measurement process. It can display average results in three ways.
The provided text describes the Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35. Here's a breakdown of the acceptance criteria and the study information:
Acceptance Criteria and Reported Device Performance
The device's performance is assessed against the accuracy requirements of ISO 81060-2:2013-05-01, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
| Acceptance Criteria (Standard Reference: ISO 81060-2:2013) | Reported Device Performance |
|---|---|
| Defined accuracy requirements of ISO 81060-2:2013-05-01 | Clinical tests were performed, and the device "comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." (Specific quantitative performance metrics like mean difference and standard deviation are not provided in this document, but the statement indicates compliance with the standard's outlined accuracy thresholds.) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the clinical test set.
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, the clinical validation study would inherently be prospective in nature.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the provided text. ISO 81060-2 typically requires measurements from trained observers using mercury sphygmomanometers or an equivalent calibrated standard device as the reference (ground truth).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated in the provided text. ISO 81060-2 specifies a protocol for obtaining reference blood pressure measurements, often involving multiple observers.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The clinical tests were performed to validate the accuracy of the automated device itself, which operates without human intervention during the measurement process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitor validation studies is typically established by trained observers using a calibrated reference method, such as a mercury sphygmomanometer or an equivalent standard. This is an implied requirement of ISO 81060-2.
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The sample size for the training set:
- This is not applicable as the device is a standalone blood pressure monitor based on oscillometric technology and does not involve machine learning algorithms that require a separate training set. The "training" in this context refers to the development and calibration of the device's internal algorithms, not a data-driven machine learning training set.
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How the ground truth for the training set was established:
- Not applicable for the reason stated above. The device's internal algorithms are based on established physiological principles and engineering design, not a machine learning training process with an external ground truth dataset.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).