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The SpaceLabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a SpaceLabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected.

The SpaceLabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort.

The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process, and display electro-cardiogram vectors (ECG), respiratory effort, non-invasive blood pressure (NIBP), and pulse oximetric oxygen saturation (SpO2) using standard ECG electrodes, NIBP cuffs, and SpO2 sensors and be exclusively used with the SpaceLabs Medical Integrated Multi-Parameter Module along with the PCMS Monitor. Operation, set-up, and alarm limit settings are all controlled by simple menu choices via the PCMS Monitor.

The SpaceLabs Medical Integrated Multi-Parameter Module is designed to acquire, process and display up to two ECG vectors and the respiratory effort signal using standard ECG electrodes plus one channel of noninvasive blood pressure and one channel of pulse oximetry.

The SpaceLabs Medical Integrated Multi-Parameter Module provides multiple lead ECG monitoring from electrodes placed on the body surface. Electrical activity of the heart is measured via multiple electrodes placed at various locations on the patient's body.
Non-invasive blood pressure measurements are acquired through a conventional inflatable cuff mechanism that is considered to be standard of care. The SpO2 channel is designed to noninvasively and continuously monitor functional oxygen saturation by the standard photoelectric pulse oximetric technique.

This 510(k) summary (K952912) describes the SpaceLabs Medical Integrated Multi-Parameter Module but does not contain details about a study proving the device meets specific acceptance criteria. Instead, it focuses on describing the device, its classification, predicate devices, and intended use.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on this document.

The document states:

• "The intended uses of this device are substantially equivalent to its predicate devices."

This implies that the device's performance is expected to be similar to its predicate devices, which would have already met their respective regulatory requirements. However, this submission itself does not detail the specific studies or data used to demonstrate this equivalency beyond the description of the device's features and intended use.

To specifically address your request, the provided input lacks the information needed.

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