(42 days)
The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model BP-410 and BP-420, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
YA HORNG BP-410 and BP-420 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Here's an analysis of the provided information to describe the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details regulatory compliance and mentions performance standards but does not explicitly list specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference, standard deviation) or present a table of reported device performance in those terms.
Instead, it refers to:
- AAMI/ANSI SP10: This is the primary standard governing automated sphygmomanometers. Meeting this standard means the device's accuracy falls within internationally recognized benchmarks for blood pressure measurement.
- General Safety (EN 60601-1:1990+A1+A2+A11+A12+A13): This ensures electrical and mechanical safety.
- Performance (EN 1060-1:1995, EN 1060-3:1997): These are European standards specific to non-invasive sphygmomanometers, covering both general requirements and specific requirements for electro-mechanical blood pressure measuring systems.
- EMC Conformity (EN 60601-1-2: 1993): Ensures electromagnetic compatibility.
Given the available information, a table would look like this:
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance (Reported) |
|---|---|---|
| Blood Pressure Accuracy | AAMI / ANSI SP10 | PASSED |
| EN 1060-1:1995, EN 1060-3:1997 | PASSED | |
| Electrical Safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASSED |
| EMC Conformity | EN 60601-1-2: 1993 | PASSED |
| Cuff Sizing | Limited to 5.3" - 8.5" (Wrist Circumference) | Intended Design Limitation |
| Intended Use Population | Adult individual, over age 18 | Intended Use Limitation |
2. Sample Size for the Test Set and Data Provenance
The document states: "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10". While it indicates that a clinical test was performed to meet the AAMI/ANSI SP10 standard, it does not specify the sample size used for this test.
- Sample Size for Test Set: Not specified in the provided documents. (AAMI SP10 typically requires a minimum of 85 subjects with specific blood pressure ranges).
- Data Provenance: Not specified. The company is based in Taiwan, so it is possible the study was conducted there, but this is not confirmed. It is also not specified if the data was retrospective or prospective, though clinical trials for AAMI SP10 are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth.
For AAMI SP10 testing, ground truth for blood pressure is established by trained observers (often nurses or physicians) using a mercury sphygmomanometer or auscultatory method, typically following a specific protocol to minimize bias (e.g., sequential simultaneous measurements).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used. In AAMI SP10, blood pressure measurements are taken by two trained observers blinded to each other's readings, and the average or difference between their readings is typically used as the reference. Discrepancies beyond a certain point might require a third observer, but this specific method is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
The document describes a standalone clinical performance test against a standard (AAMI/ANSI SP10) to determine accuracy, rather than a study comparing human readers with and without AI assistance for interpretation. The device is an automatic blood pressure monitor, which directly provides readings, not an imaging or diagnostic AI tool that assists human interpretation.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done.
The "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" and compliance with "EN 1060-1:1995, EN 1060-3:1997" refer to studies performed on the device itself (the algorithm and hardware working together) to measure its accuracy against reference measurements. This is a standalone performance assessment of the device's ability to measure blood pressure without human interpretation beyond reading the displayed values.
7. Type of Ground Truth Used
The ground truth used for performance testing to AAMI/ANSI SP10 and EN 1060 standards is typically expert auscultatory measurements (manual blood pressure readings taken by trained clinicians using a reference device like a mercury sphygmomanometer). This could be considered a form of "expert consensus" in how multiple readings by experts are handled.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is typical for a traditional medical device (like a blood pressure monitor) that relies on fixed algorithms derived from physiological principles and extensive validation rather than machine learning models that require a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for this type of device, this information is not applicable and not provided. The device's algorithm would have been developed based on established oscillometric principles and then validated through testing against human reference measurements.
§ 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).