(205 days)
The upper arm blood pressure monitor is used for non-invasive measurement and monitoring for adult's arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.
Digital Automatic Blood Pressure Monitor MD2300 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
The acceptance criteria for the Digital Automatic Blood Pressure Monitor MD2300, and the study proving its adherence to these criteria, can be summarized as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (based on ISO 81060-2:2013) | Reported Device Performance (MD2300) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Mean difference: ≤ ± 5 mmHg | Achieved (as per clinical test report) |
| Standard Deviation: ≤ 8 mmHg | Achieved (as per clinical test report) | |
| Pulse Rate Measurement Accuracy | ± 5% of the reading | Achieved (as per device specifications) |
Note: The specific numerical values for mean difference and standard deviation from the clinical test report are not provided in the document, but the document states that the testing was done "in accordance with ISO 81060-2:2013." This standard specifies the acceptance criteria for accuracy of non-invasive sphygmomanometers. Therefore, it is inferred that the device met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 patients (49 males and 51 females).
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: Prospective, as patients were "invited for the study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts. However, it mentions that the "Standard auscultation method was used as the reference blood pressure monitor." This method typically involves trained medical professionals. The ISO 81060-2:2013 standard requires that reference measurements be taken by a trained observer.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for disagreements between ground truth measurements. It states that "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013." This standard has specific requirements for the comparison of measurements between the test device and the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the accuracy of the device against a standard auscultation method, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical test described focused on the standalone performance of the Digital Automatic Blood Pressure Monitor MD2300 in measuring blood pressure and pulse rate, without a human-in-the-loop component for interpretation or assistance beyond the standard operation of the device.
7. The Type of Ground Truth Used
The ground truth used was expert measurements via the standard auscultation method. This is considered a gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The study described focuses on the validation of the device's accuracy. As a non-AI driven device (it uses an oscillometric methodology, not machine learning that would require a distinct training phase), the concept of a "training set" as understood in AI/ML contexts does not directly apply here.
9. How the Ground Truth for the Training Set Was Established
As no separate training set is explicitly mentioned or relevant for this type of device based on the provided information, how its ground truth was established is not applicable. The device's operation is based on established physical principles of oscillometry, not on learning from a 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).