(207 days)
The Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable CUFF (22-32cm) is wrapped around the upper arm at medical facilities or at home, it's supplied for OTC use.
The arm-type electronic blood pressure monitor uses fuzzy logic intelligence to detect both upper and lower pressure value simultaneously. The personalized optimal inflation level determines the result of each measurement. This equipment is composed of a main body and a cuff. The main body is composed of a central processing unit, a pressure sensor, an air pump, a solenoid valve, a uniform speed vent valve, a PCB board, and an LCD liquid crystal display.
The provided text describes the regulatory clearance of a Digital Blood Pressure Monitor (Model: YB-800) and includes information about its performance testing. I will extract the requested information based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document refers to the ISO 81060-2:2018 standard for clinical validation of automated non-invasive sphygmomanometers. For this standard, the acceptance criteria for accuracy are typically:
- Mean difference: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
- Standard deviation of differences: ≤ 8 mmHg for both systolic and diastolic blood pressure.
The document states: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018." This confirms the device met these criteria.
| Metric (Standard: ISO 81060-2: 2018) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | ||
| Mean Difference (Systolic) | ≤ ±5 mmHg | Met (Not over the limits) |
| Standard Deviation (Systolic) | ≤ 8 mmHg | Met (Not over the limits) |
| Mean Difference (Diastolic) | ≤ ±5 mmHg | Met (Not over the limits) |
| Standard Deviation (Diastolic) | ≤ 8 mmHg | Met (Not over the limits) |
| Pulse Rate Accuracy | ||
| Static Pressure | ± 3 mmHg (Bench test reference) | ± 3 mmHg |
| Pulse Rate | ± 5% (Bench test reference) | ± 5% |
Note: The "Static Pressure" and "Pulse Rate" accuracy in the comparison table of the 510(k) summary (Table 1, page 5) refers to the technical specification of the device, not necessarily the clinical accuracy determined by ISO 81060-2 which focuses on differences compared to a reference measurement.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 85 adult subjects (41 females, 44 males).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical data" testing the device, implying a prospective study specifically for this clearance.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. ISO 81060-2, which was used for validation, requires comparison to reference blood pressure measurements (e.g., auscultation by trained observers), but the specific details of these observers are not provided in this summary.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the clinical validation study. For ISO 81060-2, it typically involves comparing the device's readings to those obtained by multiple trained observers (e.g., two observers) using a standardized method, with an agreed-upon difference or resolution process if discrepancies occur. However, the specific method (e.g., 2+1, 3+1) is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study typically assesses human readers' performance with and without AI assistance, which is not relevant for a standalone blood pressure monitor.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Clinical data" section explicitly states: "YB-800 was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard evaluates the accuracy of automated non-invasive blood pressure monitors on their own, without human intervention in the measurement process (beyond positioning the cuff and starting the device).
7. Type of Ground Truth Used
The ground truth used for the clinical validation was established by reference blood pressure measurements as mandated by the ISO 81060-2:2018 standard. This standard requires "simultaneous determination of blood pressure by a reference method (e.g. auscultation by trained observers) and by the automated measurement type under test."
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This type of information is typically relevant for machine learning algorithms where data is split into training, validation, and test sets. For a traditional medical device like a blood pressure monitor, the "clinical data" described generally serves as the primary validation/test set for regulatory submission.
9. How Ground Truth for the Training Set Was Established
As no training set is described, this question is not applicable. The clinical validation focused on the performance against reference measurements in a test population.
§ 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).