(231 days)
BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel. It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
BPA-002 Electronic Blood Pressure Monitor for Upper Arm 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 measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds. There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically
The provided text describes the Jinxinbao Electronic Co., Ltd, Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002. Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (from Accuracy row of the comparison table) | Reported Device Performance (from Accuracy row of the comparison table) |
|---|---|---|
| Pressure Accuracy | ±3mmHg | Pressure: ±3mmHg |
| Pulse Accuracy | ≤5% | Pulse: ±5% |
Study Information
The device BPA-002 is stated to be compliant with the SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/ (Manual, electronic or automated sphygmomanometers) standard for clinical testing. This standard outlines the requirements for validation of automated sphygmomanometers.
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Sample size used for the test set and the data provenance:
The document does not specify the exact sample size or the data provenance (e.g., country of origin, retrospective or prospective) for the clinical tests mentioned under "SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/". The AAMI SP10 standard generally requires a specific number of subjects (e.g., 85 subjects with specific blood pressure ranges) for validation, but these details are not provided in this submission summary. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number or qualifications of experts used to establish ground truth. For AAMI SP10 compliance, ground truth is typically established by trained human observers using auscultatory methods, but the specifics are not detailed here. -
Adjudication method for the test set:
The document does not describe the adjudication method used for the test set. For AAMI SP10 compliance, a specific protocol for comparing automated readings against human observers' readings (often involving multiple observers for auscultatory ground truth) is followed. -
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:
This device is a blood pressure monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The clinical test mentioned, "SP10:2002/(R) 2008&ANSI/AAMI SP10:2002/A1:2003/", specifically assesses the standalone performance of the automated blood pressure monitor without human intervention in the measurement process, beyond initial cuff placement. The device's algorithm performs the measurement and displays the result. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For blood pressure monitors validated against the AAMI SP10 standard, the ground truth for blood pressure measurements is typically established by trained human observers using auscultatory methods (e.g., stethoscope and manometer), often with a double-blinded or an agreed-upon protocol between multiple observers (expert consensus for the auscultatory readings). -
The sample size for the training set:
This document describes evaluation of a medical device, not a machine learning algorithm that requires a "training set" in the traditional sense. The device is based on oscillometric technology and validated against established standards. -
How the ground truth for the training set was established:
As there is no "training set" in the context of a machine learning algorithm as per the question, this is not applicable. The device's underlying principles are based on established oscillometric blood pressure measurement techniques rather than a trained AI model.
§ 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).