Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683

• K Number: K222926
• Device Name: Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
• Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd.
• Date Cleared: 2023-05-05 ( 221 days)
• Product Code: DXN
• Regulation Number: 870.1130
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K193627
• Predicate For: K241590

Intended Use

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.

Device Description

The Arm Blood Pressure Monitor (model: 111, B1681, B1683) are battery-powered or DC powered, automatic, non-invasive blood pressure system and intended to be use in hospital environment or at home. The Arm Blood Pressure Monitor (model: 111, B1682, B1683) are intended for use in adult patient population with arm circumference ranging from 22 cm to 32 cm. These devices are powered by 4 x AA batteries or an AC adaptor (output:5V DC). The device arm cuff inflates using an integral pump and deflates via an electric valve. During deflation, the arm cuff pressure is monitored and pulse waveform data is extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 280 mmHg, and the pulse rate range from 40 to 199 beats/min. When the device detected irregular rhythms, " W " will display on screen. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2x99 readings can be stored in memory.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Arm Blood Pressure Monitor are related to its clinical accuracy, as measured against a reference standard. The standard used is ISO 81060-2:2018.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ISO 81060-2:2018, Criterion 1)	Reported Device Performance (Mean Difference ± Standard Deviation)
Systolic Blood Pressure (SBP)
Mean difference ≤ ±5 mmHg	1.0 mmHg
Standard deviation ≤ 8 mmHg	3.1 mmHg
Diastolic Blood Pressure (DBP)
Mean difference ≤ ±5 mmHg	0.9 mmHg
Standard deviation ≤ 8 mmHg	3.4 mmHg

Additional Acceptance Criteria (from ISO 81060-2:2018, Criterion 2):

Acceptance Criteria (from ISO 81060-2:2018, Criterion 2)	Reported Device Performance (Standard Deviation)
Systolic Blood Pressure (SBP)
Standard deviation ≤ 6.96 mmHg	2.4 mmHg
Diastolic Blood Pressure (DBP)
Standard deviation ≤ 6.96 mmHg	2.6 mmHg

Study Details Proving Acceptance Criteria

The study conducted was a clinical accuracy study conforming to ISO 81060-2:2018.

• 1. Sample size used for the test set and the data provenance:

  • Sample Size: A total of 86 subjects participated in the study.
  • Data Provenance: The study was conducted at Wanxiang Xintian Community Health Serve Center, Xixiang Street, Bao'an District, Shenzhen City, China by Shenzhen Cihai Hospital. The subjects' race was reported as Asian, and ethnicity as "Not Hispanic or Latino." The study is prospective as it describes the procedure for data collection during the study.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • The document implies the use of multiple observers (referred to as "observers" in the procedure steps b, g, and k) to determine blood pressure using the reference sphygmomanometer.
  • Their specific qualifications are not explicitly stated beyond being "observers" using a mercury sphygmomanometer, which implies training in its use for accurate blood pressure measurement.

• 3. Adjudication method for the test set:

  • The document does not explicitly describe an adjudication method for reconciling differences between observers if multiple readings were taken for the ground truth. The procedure indicates that observers "determine the subject's blood pressure," suggesting a single ground truth per measurement instance.

• 4. 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:

  • No, an MRMC comparative effectiveness study was not done. This study is for a standalone automated blood pressure monitor and does not involve human readers' interpretation or AI assistance in that context.

• 5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Yes, a standalone study was done. The device itself is an "Arm Blood Pressure Monitor" and determines blood pressure using its internal software (oscillometric method), without human interpretation required for the blood pressure values. The study directly compares the device's output to a reference standard (mercury sphygmomanometer).

• 6. The type of ground truth used:

  • The ground truth used was expert measurements via a reference sphygmomanometer (mercury sphygmomanometer). This is a recognized standard for blood pressure measurement.

• 7. The sample size for the training set:

  • The document does not specify a separate training set size. The reported study is a clinical validation study for the device's accuracy against a gold standard, in accordance with ISO 81060-2:2018. For a medical device like a blood pressure monitor, the "training" (algorithm development) would typically occur prior to this clinical validation, and the data for that is not usually disclosed in this type of submission. The 86 subjects represent the test set for clinical accuracy.

• 8. How the ground truth for the training set was established:

  • As no specific training set is outlined in this document, the method for establishing its ground truth is not provided. However, it can be inferred that developers would use similar reference methods (like mercury sphygmomanometry) during the development and calibration phases of the device.

Regulation Number and Section

§ 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).