(100 days)
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series is for use by medical professional or home user. The WBPM22 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.
Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series is a non-invasive measuring device and utilizes the oscillometric methodology to measure the blood pressure reading. The key components of device are: a pressure sensor, a electric valve and an electronic control module together with an electric pump. The electric pump inflate (and deflate) the inflatable cuff automatically according to our designed architecture.
The acceptance criteria and study proving adherence are detailed below for the Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series.
1. Table of Acceptance Criteria and Reported Device Performance
The clinical performance of the WBPM22 Series was assessed against the ISO 81060-2:2009 standard for non-invasive sphygmomanometers. The reported performance refers to the findings from the clinical test conducted.
| Metric (Criterion based on ISO 81060-2:2009) | Acceptance Criteria | Reported Device Performance (Summary from Clinical Test) |
|---|---|---|
| Blood Pressure Measurement Accuracy | Mean difference between device and reference measurement (mean of multiple readings) should be $\le \pm$ 5 mmHg for both systolic and diastolic pressure. | |
| Standard deviation of the difference between device and reference measurement should be $\le$ 8 mmHg for both systolic and diastolic pressure. | (Specific values for mean difference and standard deviation are not provided in the summary, but the report states "Testing to insure clinical accuracy of the device in accordance with ISO 81060-2:2009 as documented in Clinical Test report" implying compliance.) | |
| Pulse Rate Measurement Accuracy | Not explicitly stated as an acceptance criterion in the provided text, but implied as a measurement capability. | The device measures and displays pulse rate. |
Note: The provided 510(k) summary only states that the testing was conducted "in accordance with ISO 81060-2:2009" and that no differences in technology raised safety or effectiveness concerns. It implies that the acceptance criteria from this standard were met, but does not provide specific numerical results for mean difference and standard deviation. The predicate device's accuracy is stated as "± 3 mmHg or 2% of reading", and the new device maintains this specification. While this is a general accuracy claim, the clinical study specific criteria would be those of ISO 81060-2.
2. Sample Size and Data Provenance
- Sample Size for Test Set: 100 patients (49 males and 51 females).
- Data Provenance: The country of origin of the data is not explicitly stated, but the submission is from "GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED" in China, suggesting the study may have been conducted there. The study appears to be a prospective clinical accuracy study based on its design ("patients were invited for the study," "blood pressure measurements were repeated alternatively").
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated, but for a study following ISO 81060-2 standards, typically two trained observers (often physicians or nurses) are used for the auscultatory reference measurements. The text mentions "Standard auscultation method was used as the reference blood pressure monitor," which implies human operators obtaining these reference readings.
- Qualifications of Experts: Not explicitly stated. However, standard auscultation for blood pressure, especially in a clinical study for device validation, would typically be performed by trained healthcare professionals.
4. Adjudication Method
The adjudication method for establishing ground truth is not explicitly mentioned. However, ISO 81060-2 typically involves multiple auscultatory measurements and may include reconciliation or averaging between observers if more than one is used to minimize bias and establish a robust reference. The text states "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2:2009," which details a specific protocol for data collection, but not explicitly how discrepancies between human readings (if two observers were involved) would be handled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This clinical study was designed to assess the standalone accuracy of the device against a reference standard (auscultation), not to evaluate the improvement of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical test describes evaluating the "clinical accuracy of the device in accordance with ISO 81060-2:2009," where the device's measurements are compared directly to a "standard auscultation method" used as a reference. This is a direct measure of the algorithm's (and device's) accuracy without human interpretation or intervention in the measurement process after initiation.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus / reference method. Specifically, the "standard auscultation method" was employed as the reference blood pressure measurement. This is considered the 'gold standard' for non-invasive blood pressure measurement in many clinical contexts and for validation studies.
8. Sample Size for Training Set
The document does not explicitly mention a training set or its sample size. This type of submission (510(k) for a blood pressure monitor) is for a medical device that relies on an established oscillometric methodology rather than a machine learning or AI algorithm that would typically require a separate training set for model development. The "device" in this context is a physical product with an embedded algorithm. The clinical test described is a validation or test set evaluation for the final device, not a training activity.
9. How Ground Truth for Training Set Was Established
As there is no mention of a distinct training set for an AI/ML model, the establishment of ground truth for a training set is not applicable based on the provided document. The device uses an "oscillometric methodology" which is a well-established principle for blood pressure measurement, not a novel AI requiring a separate data-driven training phase in the context of this 510(k) summary.
§ 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).