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The Automatic Blood Pressure Monitor is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) to 16.5 inches (42 cm).

The Automatic Blood Pressure Monitor (models: CH-S693L, CH-B601L, CP-B01, CH-S603, CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L) is a kiosk-type, automated, single upper-arm cuff oscillometric BP monitor developed for measurement of BP and pulse rate in healthcare facility/hospital or at home.

It is designed for BP measurements on either the right or left upper arm and has a fixed tubular (Arm barrel) opening to insert the user's arm, with an integral single-arm cuff, which when inflated surrounds the upper arm. It is suitable for arm circumference range 18~42 cm. The device has an elbow groove to ensure correct positioning of the arm and measures BP during inflation. A wide LED screen presents systolic and diastolic BP, heart rate and time of measurement. After the user pushes the start button, the cuff is inflated automatically by an internal pump, the systolic and diastolic blood pressures are determined by oscillometric method.

Principle of operation:

The product uses the Oscillometric Measuring method to detect blood pressure.

When the user presses the "START" button to initiate the measurement, the winding mechanism, driven by a geared motor, begins to operate. It stops winding when it starts to encounter resistance from the arm. At this point, the cuff is adapted to the arm size. Subsequently, the cuff is automatically inflated by an internal pump to reach a pressure above systolic pressure, no blood flow occurs through the artery. As the cuff is deflated below the systolic pressure, the reducing pressure exerted on the artery allows blood to flow through it and sets up a detectable vibration in the arterial wall. When the cuff pressure falls below the patient's diastolic pressure, blood flows smoothly through the artery in the usual pulses, without any vibration being set up in the wall. Vibrations occur at any point where the cuff pressure is sufficiently high that the blood has to push the arterial wall open in order to flow through the artery. The vibrations are transferred from the arterial wall, through the air inside the cuff, into a transducer in the monitor that converts the measurements into electrical signals. Hence when it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and pulse rate.

This document is a 510(k) clearance letter for an Automatic Blood Pressure Monitor, which means it describes a non-invasive blood pressure measurement system, not an AI/ML device in the context of the requested questions. The provided text is a standard FDA 510(k) summary for a traditional medical device and does not contain information about AI model performance, expert ground truth adjudication (for AI), or MRMC studies.

Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text because they pertain to AI/ML device studies, which is not what this document describes.

However, I can extract information related to the device's performance based on the provided clinical accuracy testing for the Automatic Blood Pressure Monitor.

Acceptance Criteria and Device Performance (Non-AI/ML Device):

The device's clinical accuracy was tested according to ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01. The document explicitly states:

"The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01."

This standard outlines the requirements for clinical investigations of intermittent automated measurement type non-invasive sphygmomanometers. While the specific numerical performance metrics (e.g., mean difference and standard deviation of differences between device and reference measurements) are not quantitatively stated in the summary table, the statement of compliance confirms that the device met the acceptance criteria defined by this international standard for blood pressure measurement accuracy.

The summary also specifies instrumental accuracy for blood pressure and pulse rate:

• Blood Pressure Measurement Accuracy: ±3 mmHg
• Pulse rate measurement accuracy: ±5%

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Regarding the specific questions about AI/ML studies:

1. A table of acceptance criteria and the reported device performance: See table above. More specific quantitative clinical performance results (e.g., mean difference and standard deviation of differences of BP readings compared to reference) are not explicitly detailed in the provided summary but are implied by the compliance statement.
2. Sample size used for the test set and the data provenance:
   • Test Set Sample Size: 85 subjects.
   • Data Provenance: Not specified (e.g., country of origin). It's a clinical trial, implying prospective data collection for the validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is for a traditional blood pressure monitor validated against a reference sphygmomanometer (aneroid/auscultation method), not an AI/ML device requiring expert consensus for ground truth. The reference device was a "CM-BPM-D Aneroid sphygmomanometer" by Shanghai Caremate Medical Device Co. Ltd.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and study. The accuracy is determined by comparison to the reference measurements.
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: Not applicable. This is a traditional medical device, not an AI/ML product assisting human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a standalone automatic blood pressure monitor. Its performance is measured directly, not as an algorithm's output to be interpreted by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the clinical accuracy study was established by measurements from an "Aneroid sphygmomanometer" using the "Aneroid/auscultation method." This is the established reference method for validating automatic BP monitors per ISO 81060-2.
8. The sample size for the training set: Not applicable. This is a traditional device; there is no "training set" in the AI/ML sense. The device's measurement algorithm is predetermined and fixed.
9. How the ground truth for the training set was established: Not applicable. No AI model training set.

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