(57 days)
The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.
Digital Automatic Wrist Blood Pressure Monitor MD3200 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 wrist 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 document describes the Digital Automatic Wrist Blood Pressure Monitor MD3200 and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily assessed against accuracy values for blood pressure and pulse rate measurements.
| Acceptance Criteria (Standard ISO 81060-2:2013, likely) | Reported Device Performance |
|---|---|
| Blood Pressure Measurement Accuracy: ± 3 mmHg | ± 3 mmHg |
| Pulse Rate Measurement Accuracy: ± 5 % of the reading | ± 5 % of the reading |
Note: The document explicitly states that the device's accuracy for BP measurement is ± 3 mmHg and for pulse rate measurement is ± 5% of the reading. It also mentions compliance with ISO 81060-2:2013 for clinical accuracy, which is the standard outlining these accuracy requirements.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients (45 males and 55 females)
- Data Provenance: The document does not explicitly state the country of origin but mentions the study was conducted to insure clinical accuracy in accordance with ISO 81060-2:2013. The nature of the study (patients invited for measurements) indicates it was prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: The document does not specify the number of experts but states that the "Standard auscultation method was used as the reference blood pressure monitor". This implies trained medical professionals (e.g., doctors, nurses, or technicians certified in blood pressure measurement) would have performed the auscultation.
- Qualifications of Experts: Not explicitly stated, but implicitly, they would be qualified to perform the auscultation method accurately.
4. Adjudication Method for the Test Set
- The document states: "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 implies a direct comparison method where readings from the device are compared to the reference standard (auscultation) taken at the same time or in alternating sequences. There's no mention of an "adjudication" process in the typical sense of multiple experts independently reviewing and then resolving discrepancies. The auscultation itself serves as the ground truth.
5. 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, an MRMC comparative effectiveness study was not done. This study concerns a standalone blood pressure monitoring device. It does not involve human readers interpreting images or data, nor does it involve AI assistance in that context. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The device itself is an "Automatic Wrist Blood Pressure Monitor," implying it operates autonomously to measure and display blood pressure and pulse rate. The clinical test evaluated the accuracy of this device's measurements against a reference standard (auscultation) in a clinical setting, without a human "in the loop" to interpret the device's readings and make a diagnosis. The device generates the readings directly.
7. The Type of Ground Truth Used
- The ground truth used was expert measurement/reference standard, specifically the "Standard auscultation method." Auscultation by a trained professional is considered the 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 size. Blood pressure monitors like this typically do not involve machine learning models that require a distinct training set in the same way an AI diagnostic tool would. The device's calibration and algorithm development would have occurred during its engineering phase, likely using internal testing data, but this is not discussed in terms of a "training set" for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided in the document.
§ 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).