(245 days)
Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
The Arm Blood Pressure Monitor, including XY-B01, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09, 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 with arm circumference of 220-320mm through oscillometric method. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The Arm Blood Pressure Monitor is composed of monitor unit and arm cuff. Of which, the main unit contains main control circuit board, air pump, deflation valve, LCD and shell. The seven models have the same intended use, working principle, measuring range, cuff, and conformance standard, except for appearance and power supply. The devices are powered by 4AA batteries (XY-B02) or 4AAA batteries (other models). The Arm Blood Pressure Monitor has a memory function that automatically stores 2*60 sets data of the latest measurements.
Based on the provided FDA 510(k) summary for the Arm Blood Pressure Monitor (XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09), here's a description of the acceptance criteria and the study that proves the device meets them:
Device: Arm Blood Pressure Monitor (XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
Purpose: Noninvasive Blood Pressure Measurement System
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the primary acceptance criteria are based on recognized international standards for non-invasive blood pressure monitors, specifically ISO 81060-2:2018 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers). The acceptance criteria and the device's performance against them are:
| Acceptance Criteria (Based on ISO 81060-2:2018) | Reported Device Performance (Clinical Test) |
|---|---|
| For systolic pressure, the mean error shall be +5 mmHg or less. | Mean error for systolic pressure: Not explicitly stated as one number, but the summary states "all data is not over the limits," implying it met this requirement. |
| For systolic pressure, the standard deviation shall be 8 mmHg or less. | Standard deviation for systolic pressure: Not explicitly stated as one number, but the summary states "all data is not over the limits," implying it met this requirement. |
| For diastolic pressure, the mean error shall be +5 mmHg or less. | Mean error for diastolic pressure: Not explicitly stated as one number, but the summary states "all data is not over the limits," implying it met this requirement. |
| For diastolic pressure, the standard deviation shall be 8 mmHg or less. | Standard deviation for diastolic pressure: Not explicitly stated as one number, but the summary states "all data is not over the limits," implying it met this requirement. |
Additionally, the device must comply with several other non-clinical standards for safety and performance:
- IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
- IEC 60601-1-11:2015 (Requirements for medical electrical equipment and systems used in the home healthcare environment)
- IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
- ISO 10993-10:2010 (Biological evaluation - irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation - in vitro cytotoxicity)
The "Performance Data" section states that the Arm Blood Pressure Monitor "comply with" these standards, indicating they met the acceptance criteria for these non-clinical aspects.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 120 subjects (55 female and 65 male).
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: The study was a prospective clinical test conducted to verify compliance with ISO 81060-2:2018.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test data. For blood pressure clinical validation studies following ISO 81060-2, ground truth is typically established by trained and certified medical professionals (e.g., physicians, nurses) using a reference sphygmomanometer (mercury sphygmomanometer or highly accurate oscillometric device) in a strict protocol.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. For blood pressure validation, ground truth readings are often taken by multiple observers, and the average or a specific methodology is used to minimize observer bias, but this is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study was not conducted. This device is a standalone measurement device, not an AI-assisted diagnostic tool where human readers assess cases. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical test described is essentially a standalone performance validation of the device's measurement algorithm. The study validates the accuracy of the device itself (analogous to "algorithm only" in this context) against a known reference standard, without human interpretation of complex outputs beyond reading the blood pressure values.
7. The Type of Ground Truth Used
The ground truth for the accuracy validation was established through comparison with reference measurements taken from the 120 subjects. This is standard for blood pressure device validation, where the device's readings are compared against simultaneously obtained, highly accurate reference blood pressure measurements (e.g., using a auscultatory method with a mercury sphygmomanometer or another validated reference device). The summary explicitly states the test was conducted to verify that the proposed device met the requirements of ISO 81060-2:2018, which outlines the methodology for establishing this ground truth.
8. The Sample Size for the Training Set
This document does not specify a separate "training set" because this device is a hardware medical device with an embedded algorithm for blood pressure measurement, rather than a machine learning model developed with a distinct training and test dataset. The performance "training" (i.e., design and calibration) is part of the engineering and manufacturing process, and the clinical test is the validation of the final product's performance.
9. How the Ground Truth for the Training Set Was Established
As noted above, there isn't a "training set" in the sense of a machine learning dataset. The "ground truth" used during the device's development, calibration, and internal testing phases would have been established through a rigorous process of clinical measurements and calibration against reference standards in a controlled environment, consistent with the principles of blood pressure measurement accuracy outlined in relevant standards.
§ 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).