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Arm Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~36 cm.

The Arm Blood Pressure Monitor is a battery powered automatic non-invasive pressure monitor, powered by 4 x1.5V AAA battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function for data reviewing. The proposed Arm Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided text describes the 510(k) summary for an Arm Blood Pressure Monitor (models OB30, OB31, OB32, OB33). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information primarily focuses on the device's technical specifications and how it meets the requirements for a non-invasive blood pressure measurement system.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Arm Blood Pressure Monitor are primarily defined by adherence to recognized international standards, particularly ISO 81060-2 for clinical performance, and other IEC standards for safety and electromagnetic compatibility.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The clinical performance testing included 85 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the submitter's location in China (Yibin Junxin Electronics Technology Co., Ltd., SiChuan, China) and the application correspondent's location also in China (Share Info (Guangzhou) Medical Consultant Ltd., Guangzhou, China), it is highly probable that the study was conducted in China. The study was a prospective clinical performance test conducted to meet the ISO 81060-2 standard.
• Subject Demographics: Aged from 22 to 81, with 52.9% male and 47.1% female participants. The limb size distribution complied with clause 5.1.4 of ISO 81060-2.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not specify the number of experts or their qualifications. For blood pressure measurement device validation, the ground truth is typically established by trained clinical personnel using a reference standard device (e.g., a mercury sphygmomanometer) and following a strict protocol as outlined in ISO 81060-2.

4. Adjudication Method for the Test Set

• The document does not explicitly mention an adjudication method. In the context of blood pressure device validation (ISO 81060-2), ground truth derivation involves simultaneous or near-simultaneous measurements by trained observers using a reference method, against which the device's readings are compared. It's a direct comparison method rather than an "adjudication" in the sense of resolving disagreements between multiple independent expert interpretations, as would be common in imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. For a blood pressure monitor, the study evaluates the device's accuracy against a clinical reference standard, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, a standalone performance study was done. The clinical performance testing described is precisely a standalone performance evaluation of the device. The device itself performs the measurement using an oscillometric technique, and its readings are directly compared to a reference standard to assess its accuracy. There is no "human-in-the-loop" in the generation of the device's measured blood pressure values.

7. Type of Ground Truth Used

• The type of ground truth used was a clinical reference standard, as specified by ISO 81060-2. This typically involves simultaneous or sequential measurements by a trained observer using a validated reference method (e.g., a mercury sphygmomanometer with a Y-adapter or similar setup) against which the test device's readings are compared. It is a form of outcomes/measurement data validated against a gold standard in a clinical setting.

8. Sample Size for the Training Set

• The document does not specify the sample size for a training set. This device is a hardware product with embedded software and an algorithm for oscillometric blood pressure measurement. While the algorithm was developed, the document focuses on the validation test set (85 subjects) and compliance with standards. It does not provide details on the data used for the development or training of the oscillometric algorithm itself. This information is typically proprietary and not included in a 510(k) summary unless specific software modifications or AI components require it.

9. How the Ground Truth for the Training Set Was Established

• As the document does not specify a training set or its size, it also does not provide information on how the ground truth for a training set (if applicable for algorithm development) was established. For blood pressure monitoring, algorithms are usually developed and refined using large datasets of oscillometric waveforms and corresponding reference blood pressure values, established through similar rigorous clinical measurement protocols used for validation.

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