(221 days)
This Upper Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.
The Upper Arm Blood Pressure Monitor, including ZK-B869, ZK-B869, ZK-B872 and ZK-B876, can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 32cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The initial inflation pressure of the cuff is zero pressure. When start the device, the cuff will be inflated and deflated. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve, LCD screen and arm cuff. The ZK-B868 is powered by 4 AA dry batteries (DC 6V), other models are powered by 4 AAA dry batteries (DC 6V). The device has a memory function that automatically stores some sets data of the latest measurements. It can also display the latest measurement result. Additionally, the device also can read the data through voice broadcast function. The four models have the same intended use, working principle, measuring range, accuracy, cuff, conformance standard; only in appearance and power supply have some difference.
This document describes the 510(k) summary for the "Upper Arm Blood Pressure Monitor" (Models: ZK-B868, ZK-B869, ZK-B872, ZK-B876) by ShenZhen ZhengKang Technology Co., Ltd. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to blood pressure measurement accuracy.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document mentions compliance with the standard ISO 81060-2 (Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type). This standard sets widely accepted accuracy criteria for blood pressure monitors.
While the document doesn't explicitly present a table of acceptance criteria and reported performance in a single table, it states the device "passed" the performance testing according to ISO 81060-2.
The Accuracy section within the comparison table (page 5) lists the following for the targeted device, which are the inherent performance characteristics the device aims to meet:
| Parameter | Targeted Device (Claimed Accuracy) |
|---|---|
| Pressure | ±3mmHg (±0.4kPa) |
| Pulse Rate | ±5% |
These values are consistent with the requirements of ISO 81060-2. The statement that the performance testing was "performed to, and passed" these standards implies that the device achieved these accuracies within the limits defined by ISO 81060-2.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for the clinical validation according to ISO 81060-2. It also does not specify the country of origin of the data, nor whether the study was retrospective or prospective.
ISO 81060-2 typically requires a prospective study with a specific number of subjects (usually 85 subjects with specific blood pressure ranges) for clinical validation. However, these specific details are not present in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For a blood pressure monitor, the "ground truth" (or reference measurement) is typically established by trained observers (often physicians or nurses) using a standardized auscultatory method, with the accuracy verified against a mercury sphygmomanometer or highly accurate validated electronic device.
The document does not specify the number of experts or their specific qualifications used to establish the ground truth for the clinical validation. ISO 81060-2 mandates specific procedures for reference measurements, involving two trained observers, but these details are not stated here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set. For clinical validation of blood pressure monitors, the ISO 81060-2 standard outlines a specific methodology for collecting simultaneous reference measurements from two trained observers, and if there are significant discrepancies, a third observer might be involved. However, this level of detail is not present in the provided text.
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
This section is not applicable to this device. The device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently a "standalone" automated measurement system. Its performance, as validated against ISO 81060-2, represents its algorithm-only performance in measuring blood pressure and pulse rate. The study is a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood pressure measurement is established through:
- Simultaneous auscultatory measurements by trained observers using a reference sphygmomanometer (mercury or a highly accurate validated electronic device). This is the standard method prescribed by ISO 81060-2.
While the document doesn't explicitly state "auscultatory measurements," the reference to ISO 81060-2 implies this methodology for ground truth establishment.
8. The sample size for the training set
This device is a hardware product with embedded software/firmware for an established measurement principle (oscillometric). It is not an AI/ML device that undergoes "training" in the typical sense of a deep learning model. Therefore, the concept of a "training set" as it applies to AI/ML is not relevant here, and no information on a training set size is provided.
9. How the ground truth for the training set was established
As explained above, there is no "training set" in the AI/ML context for this type of device. The accuracy of the device is assessed through clinical validation against established ground truth measurements from human observers, as per ISO 81060-2, not "trained" on a dataset.
§ 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).