(94 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 quickly and easily measure your systolic 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 MD2400 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Digital Automatic Wrist Blood Pressure Monitor MD2400:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure measurement devices are typically defined by international standards like ISO 81060-2. The document references this standard, indicating its use for clinical accuracy testing. The specific criteria are based on the statistical agreement between the device measurements and a reference standard (auscultation).
| Acceptance Criteria (Based on ISO 81060-2:2013) | Reported Device Performance |
|---|---|
| For all values (Systolic and Diastolic): | |
| Mean difference (device - reference) ≤ ± 5 mmHg | Not explicitly stated in the provided text, but implied to have met the standard. |
| Standard deviation of differences ≤ 8 mmHg | Not explicitly stated in the provided text, but implied to have met the standard. |
| For individual values (Systolic and Diastolic): | |
| Blood Pressure Measurement Accuracy: ± 3 mmHg | ± 3 mmHg |
| Pulse Rate Measurement Accuracy: ± 5% of reading | ± 5% of the reading |
Note: The document states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2013 as documented in Clinical Test report." This implies the device met the requirements of this standard, but the specific mean difference and standard deviation values are not directly presented in this summary.
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. It indicates it was a "Clinical Test" and mentions "One hundred patients... were invited for the study." This suggests it was likely a prospective clinical study specifically conducted for this device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established using the "Standard auscultation method." This method involves human observers, typically trained medical professionals.
- Number of Experts: Not explicitly stated, but typically at least two independent observers are required for auscultation in such studies to ensure accuracy and minimize observer bias, as per ISO 81060-2 standards.
- Qualifications of Experts: Not explicitly stated. However, for a clinical study adhering to ISO 81060-2, the observers performing auscultation would be medically trained individuals (e.g., physicians, nurses, or trained technicians) proficient in blood pressure measurement via auscultation.
4. Adjudication Method for the Test Set
The document mentions that measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2013."
- Adjudication Method: Not explicitly detailed. ISO 81060-2 often specifies a protocol for how repeated measurements are compared and how discrepancies between observers (if multiple were used) are handled, but this document does not provide those specifics. It's implied that the auscultation readings served as the reference, but the method for reconciling multiple auscultation readings (if applicable) is not given.
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
- This question is not applicable to this device. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The entire clinical accuracy test described is a standalone performance evaluation. The device (Digital Automatic Wrist Blood Pressure Monitor MD2400) was tested on its own to measure blood pressure, and its readings were compared against the reference method (auscultation) without direct human intervention in the device's measurement process.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus (Standard auscultation method). This is considered the clinical gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not mentioned. Blood pressure monitors like the MD2400, which rely on oscillometric principles, are generally calibrated using established physical models and reference measurements, rather than being "trained" on large datasets in the way an AI algorithm would be. The clinical study described is a validation study, not a training study. The device likely uses pre-programmed algorithms based on physiological models and empirical data from general populations to convert oscillometric waveforms into blood pressure readings.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable as there isn't a "training set" in the sense of a machine learning-based device. The underlying algorithms for oscillometric blood pressure measurement are developed and refined based on extensive physiological research, engineering principles, and empirical data from various populations. The "ground truth" for developing these algorithms would stem from studies correlating oscillometric waveforms with invasive arterial pressure measurements or highly accurate auscultatory methods over many years of research in the field of blood pressure monitoring.
§ 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).