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VitaLogik 6000/6500 is intended for use as a multiparameter physiological patient monitoring system.

The VitaLogik 6000/6500 can monitor ECG/heart rate, invasive blood pressures , temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2.

This effectively allows the VitaLogik 6000/6500 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages.

The Mennen Medical VitaLogik 6000/6500 is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring.

The following are examples of intended clinical applications:

• · Critical Care Patients
• · Cardiac Step-down/Telemetry Units
• · Emergency Departments
• · Intra-operative (Anesthesia) Monitoring
• · Post Anesthesia Care

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I am sorry, but the provided text does not contain the detailed information needed to construct the table of acceptance criteria and the comprehensive study description you requested. The document is a 510(k) clearance letter for a patient monitor (VitaLogik 6000/6500), which declares its substantial equivalence to predicate devices and lists its intended uses.

It does not include:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
• Details of a performance study (like test set size, data provenance, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance).
• Information about the training set size or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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