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It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment's follow-up when it is necessary to measure a patient's blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed:

• for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human beings.
• for recording during a predetermined period of time the above mentioned measurements (up to 250 measurements).
• to be used along with the ABP-2000 G-3 software for programming as well as record keeping and display in a graphical or tabular report.

The ABP-2000 G-3 is an automated, ambulatory, non-invasive blood pressure (NIBP) monitor microprocessor based. The device uses an oscillometric linear deflation technique to determine blood pressure. A cuff is inflated by an internal electrical air pump, and the deflation process is controlled by two internal valves. During deflation, the arterial blood pressure pulses are sensed by the device by means of cuff pressure changes, which are analyzed by the microprocessor in order to determine the blood pressure. The ABP-2000 G-3 can record patient's blood pressure at different and previously determined intervals as clinically scheduled, or can be activated by pressing the Start/Stop button.
The physician can program the measurement intervals as well as the LCD display (it can be disabled to prevent patient from seeing the readings) and then, the device is placed on the patient at the physician's office and is usually worn for 24 hours. The ABP-2000 G-3 software allows the physician to setup the device, the display and to keep all the records. The information is stored on an internal memory that will register each reading. All the data can be downloaded (via serial cable) into the computer software once the study has ended. The information can be analyzed and presented in either graphical or table format, and printed in either format using the PC software.

The provided text describes the ABP-2000 G-3, an Ambulatory Blood Pressure Monitor, and its performance testing in a 510(k) submission. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions compliance with standards.

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

This information is not provided in the document. The document refers to compliance with established protocols (AAMI SP-10 and BHS), which typically involve specific testing methodologies, but details about expert involvement in establishing ground truth for this specific device's test set are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device is an Ambulatory Blood Pressure Monitor, which is a measurement device, not an AI-assisted diagnostic tool for image interpretation or similar. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers and AI assistance is not applicable and was not done for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone automated blood pressure monitor. Its performance, as described by compliance with AAMI SP-10 and BHS protocols, inherently refers to its standalone performance in measuring blood pressure. There is no "human-in-the-loop" aspect to its measurement function, beyond a human initiating the measurement and potentially interpreting the results.

7. The Type of Ground Truth Used

The ground truth for blood pressure measurement devices is typically established through comparison with a reference standard, often involving direct intra-arterial measurement or a highly accurate auscultatory method performed by trained personnel. While not explicitly detailed for this specific study, the compliance with AAMI SP-10 and British Hypertension Society's protocol implies that established methods for determining accurate blood pressure readings were used as the ground truth. These protocols define specific procedures for comparing the device's readings against these reference standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The ABP-2000 G-3 is a microprocessor-based device that uses an oscillometric linear deflation technique. It is not an AI/machine learning model in the modern sense that learns from a "training set" of data. Its "training" would be its design, calibration, and validation against established engineering principles and clinical standards.

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

This information is not applicable/not provided for the reasons stated in point 8.

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