(214 days)
The Globalcare GUS622 automatic Blood Pressure Monitor is indicated for the non-invasive measurement of diastolic and systolic blood pressures and pulse rate of adults by means of an inflatable cuff which is wrapped around the upper arm. The cuff circumference is limited to 22 to 42 cm.
The Globalcare GUS622 Blood Pressure Monitor is an automatic upper arm blood pressure monitor intended for non-invasive measurement or monitoring of adults' arterial blood pressure and pulse rate. The device is powered by batteries or by a mains-connected power supply. The Globalcare GUS622 Blood Pressure Monitor comprises the following parts: Blood pressure monitor main device x1, Upper arm cuff x1, 1.5 V LR03 AAA batteries x4, Storage bag x1, Instructions for use x1, 100-240Vac 50/60Hz power supply (optional) x1. None of the parts included with the device are supplied in a sterile condition. The Globalcare GUS622 Blood Pressure Monit is an electronic unit incorporating a screen that displays results and other information relevant to device operation. The device is powered by batteries or by a mains-connected power adapter, and is designed for home ('OTC') use. The clinical outputs from the GUS622 Blood Pressure Monitor are: Systolic pressure (mm Hg), Diastolic pressure (mm Hg), Pulse rate (1/min), Cardiac arrhythmia (Irregular heart beat (IHB)) symbol, Level of risk, Hemodynamic Rest Condition (HSD) indication. The device operates on the oscillometric method: pressure sensors on the cuff are used to capture pulse waves during constricted blood flow and the device then computes the results for display by means of an algorithm which analyses the pressures transmitted during arterial oscillations that occur during cuff deflation. Irregular heart beat (IHB) is detected by measuring the interval time between each heart beat and comparing these values with the average heart beat interval (heart beat per minutes shown on the display). If the difference between any heart beat interval and the average is higher or lower than 25 %, the device shows the cardiac arrhythmia (IHB) symbol on the display. The pulse rate is determined by calculating the frequency of the cuff, which are cardiac synchronous. The GUS622 is controlled by software which calculates the blood pressure (diastolic and pulse rate by the oscillometric method. To do this, it also controls the pneumatic components to inflate the cuff (with a pump), holds the cuff pressure, and then deflates the cuff (by means of a solenoid valve). The software collects the relevant data from the pressure sensor during deflation. The software also drives the LCD display, from which the user can read the result of the blood pressure and pulse rate measurements, and undertakes the Hemodynamic Rest Condition (HSD) detection calculations, and reports whether any irregular heart beat is occurring.
The provided document is a 510(k) summary for a blood pressure monitor, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects (such as training data, expert adjudication, MRMC studies, standalone algorithm performance, etc.) are not directly applicable to the information contained in this document.
However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, as described for a non-AI/ML medical device like a blood pressure monitor.
Here's the breakdown based on the provided text, focusing on the performance and validation of the Globalcare GUS622 Blood Pressure Monitor:
Acceptance Criteria and Device Performance for Globalcare GUS622 Blood Pressure Monitor
The acceptance criteria for this vital signs monitoring device are primarily based on established international standards for noninvasive sphygmomanometers, specifically ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards define the accuracy requirements for blood pressure measurements.
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (from Standards / Industry Norm) | Reported Device Performance (Table 1: Accuracy) |
|---|---|---|
| Blood Pressure | ||
| Pressure Accuracy | ±3 mmHg | ±3 mmHg |
| Pulse Rate | ||
| Pulse Rate Accuracy | ±5% | ±5% |
Note: The document explicitly states that the GUS622 has been tested and found to be in compliance with ISO 81060-2:2013 and EN 1060-3:1997+A2:2009 for clinical performance. These standards inherently define the accuracy requirements. The "Accuracy" row in Table 1 directly reflects the performance against these criteria.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states "Clinical performance: ISO 81060-2:2013". ISO 81060-2 specifies requirements for the clinical investigation of non-invasive sphygmomanometers, including patient population size. While the exact number of subjects for the clinical study is not explicitly stated in this 510(k) summary, compliance with ISO 81060-2:2013 implies that the study was conducted with a sufficient number of subjects (typically a minimum of 85 subjects with specific demographic distribution as per the standard).
- Test Set Sample Size: Not explicitly stated, but compliance with ISO 81060-2:2013 implies a sample size that meets the standard's requirements (typically a minimum of 85 subjects).
- Data Provenance: Not explicitly stated. Clinical studies for compliance with international standards are generally prospective. The manufacturer is Globalcare Medical Technology Co., Ltd in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For blood pressure monitors, the "ground truth" during clinical validation is typically established by trained observers (often two or more) taking simultaneous auscultatory measurements using a mercury reference sphygmomanometer, in accordance with the protocols outlined in standards like ISO 81060-2.
- Number of Experts: Not explicitly stated, but clinical validation for blood pressure monitors generally involves multiple trained observers. ISO 81060-2, for example, specifies the use of multiple observers (e.g., at least two) for reference measurements.
- Qualifications of Experts: Not explicitly stated, but they would be trained according to the requirements of the standard, typically involving specific training in auscultatory blood pressure measurement.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
For blood pressure monitor validation studies (e.g., under ISO 81060-2), ground truth is established through simultaneous measurements by multiple trained observers. The method is often a comparison of the device's readings against the average or reconciled readings from these observers.
- Adjudication Method: Not explicitly detailed, but ISO 81060-2 outlines procedures for agreement between observers and handling discrepancies, implying a form of "adjudication" through simultaneous, blinded measurements.
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
- N/A. This is a traditional medical device (blood pressure monitor), not an AI/ML device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone algorithm-driven device (it operates on the oscillometric method with a software algorithm). The performance data cited (compliance with ISO 81060-2) reflects the overall device performance, which is the standalone performance in this context. The human "in the loop" is the user taking the measurement, but the measurement itself is produced by the device's internal algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Paired and simultaneous (or sequential in close proximity) reference measurements taken by trained observers using a validated reference method (e.g., mercury sphygmomanometer) in a clinical setting. This is considered the "expert consensus" or "reference measurement" gold standard for blood pressure validation.
8. The sample size for the training set
- N/A. This information is for an AI/ML device's training data. For a traditional device like this, there isn't a "training set" in the AI/ML sense. The device's algorithm would have been developed and tested internally, but not based on a "training set" of patient data that is then distinct from a "test set" in the way an AI model is trained and validated.
9. How the ground truth for the training set was established
- N/A. See point 8.
§ 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).