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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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