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Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel ECG signals and non- invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years.

Vasomedical-Biox Ambulatory ECG CB Series Analysis System Software allows transfer of ECG and Blood Pressure data from the Recorder to a Windows based PC-based computer program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

Vasomedical's Ambulatory ECG and Blood Pressure Recorder is intended to be used as a combined Holter Ambulatory Electrocardiograph device and a non-invasive Ambulatory Blood Pressure Monitor for the purpose of screening ECG rhythms and blood pressure measurements for periods up to 24 hours. Blood Pressure measurements are obtained using oscillometric signals at intervals set by the physician or on demand. Cardiac rhythm is acquired by 3 channel ECG signals. The Recorders are intended for adults and children over the age of six years old.

The CB series AECG/BP Analysis system is a PC based diagnostic application running on a Microsoft Windows operating system. It is designed in conjunction with the CB series Holter Recorder and analyzes prerecorded patient's ECG and/or ABP data that has been stored by CB series Recorder, or other compatible Holter Recorders. The system provides multi-channel full disclosure for arrhythmia and ST events and synchronous three channel ECG and ABP pulses, and creates summary tables, statistics, trends, and final report regarding a variety of cardiac data indices. The cardiac data provided by the system is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Recorders are portable, microprocessor based devices that are worn by a patient with the use of a carrying case and strap.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) Summary for the Vasomedical-Biox Combined Ambulatory ECG and Blood Pressure Recorder 2301 and its associated Analysis Software.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove it meets specific performance acceptance criteria through independent studies.

Here's what the document does state, and why it doesn't align with your request:

• Device Description and Intended Use: It describes the device's function (combined Holter ECG and non-invasive ambulatory blood pressure monitor for screening and measurement) and its intended users (adults and children over six years old).
• Predicate Devices: It lists two predicate devices: the SunTech Medical Instruments Inc., Automatic Blood Pressure Measurement System, Oscar 2, and the Vasomedical-Biox 1305, 3 Channel ECG Holter Monitor and CB Series Analysis Software. The document explicitly states: "Technological and functional characteristics of the device listed in this 510(k) Premarket Notification is essentially the same as those of the predicate devices. The device listed in this 510(k) Premarket Notification is therefore substantially equivalent to the predicate devices."
• No Performance Data: There is no mention of a study conducted to establish performance metrics, acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for this specific device. The filing focuses on substantial equivalence to existing devices.
• Software Function: The software's role is described as transferring and analyzing pre-recorded data, providing multi-channel disclosure for events, summary tables, statistics, and trends. Crucially, it states: "The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis." This indicates the software does not have an AI component for diagnosis that would typically require a study with performance acceptance criteria as you've outlined.

Therefore, I cannot provide the requested table and study details because the provided text does not contain this information. The 510(k) process for this device appears to rely on demonstrating substantial equivalence to predicate devices rather than presenting novel performance study data against specific acceptance criteria.

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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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