(137 days)
The Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
The Blood Pressure Monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
Acceptance Criteria and Study for Blood Pressure Monitor (RAK series)
The provided document describes the acceptance criteria and the study that proves the Blood Pressure Monitor (RAK series) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Blood Pressure Monitor are based on various international standards, primarily IEC 80601-2-30: Medical electrical equipment – Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, and ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. These standards define the accuracy requirements for blood pressure measurement devices.
| Acceptance Criteria (Standard Reference) | Specific Requirement | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Mean error of differences (device vs. reference) | Not over the limits of ISO 81060-2:2018 |
| (ISO 81060-2:2018) | Standard deviation of differences (device vs. reference) | Not over the limits of ISO 81060-2:2018 |
| Absolute difference for individual subject (within 5 mmHg) | Implicitly met if mean error & SD are within limits | |
| Blood Pressure Measurement Range | 25-255 mmHg | 25-255 mmHg (verified by IEC 60601-1 and IEC 80601-2-30) |
| Heart Rate Measurement Range | 40-199 bpm | 40-199 bpm |
| Heart Rate Accuracy | ± 5% | ± 5% |
| Electrical Safety | Compliance with IEC 60601-1: 2005+AMD1 (2012) +AMD2 (2020) | Device complies |
| EMC | Compliance with IEC 60601-1-2: 2014/AMD1:2020 | Device complies |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device complies (Cytotoxicity, Skin Sensitization, Irritation) |
| Usability | Compliance with IEC 60601-1-6:2010+A1:2013+A2:2020 | Device complies |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015 +A1:2020 | Device complies |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 adult subjects were used for the clinical validation.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It also does not specify if the study was retrospective or prospective, but clinical validation studies for device clearance are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document refers to a "clinical test" for validation in accordance with ISO 81060-2:2018. This standard typically requires concurrent or sequential measurements by a trained observer using a standard reference sphygmomanometer (e.g., mercury sphygmomanometer). However, the specific number of experts (e.g., clinicians, technicians) involved in establishing the ground truth measurements for the test set and their qualifications are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the clinical test set. ISO 81060-2:2018 outlines specific protocols for obtaining reference blood pressure measurements, often involving multiple observers and an agreed-upon method for handling discrepancies, but the specific details for this study are not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs without AI assistance. The device in question is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical validation, in accordance with ISO 81060-2:2018, evaluates the accuracy of the algorithm and device against a reference standard without human-in-the-loop assistance. The results state that "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018," indicating direct measurement of the device's accuracy.
7. Type of Ground Truth Used
The ground truth used for the clinical validation was established by concurrent or sequential measurements using a reference manometer (as per ISO 81060-2:2018 methodology). This is a gold standard for blood pressure validation studies, effectively functioning as an "expert consensus" on the true blood pressure readings, established by highly trained personnel following a strict protocol.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This is typical for medical devices that are validated directly against established performance standards using a test set, rather than being developed using machine learning models that require distinct training and testing datasets. The device's underlying algorithm is likely based on established oscillometric principles and refined through engineering, not trained on a large dataset in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, information on how its ground truth was established is not applicable or provided.
§ 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).