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The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare or by personnel trained in its proper use for:

1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.

2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

3. When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor

4. The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with preexisting peripheral arterial line access

5. In addition to arterial blood pressure parameters and cardiac output, the LiDCOunty Monitor of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/ Index

Location of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Suites Step Down / High Dependency Units Trauma/Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

Not Found

I am sorry, but the provided text from the FDA 510(k) K163334 document for the LiDCOunity v2 Hemodynamic Monitor does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria in the context of an AI/ML-based medical device.

The document is a clearance letter and the "Indications for Use" statement for a non-AI/ML medical device. It focuses on:

• Substantial Equivalence Determination: The FDA has determined the LiDCOunity v2 Monitor is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: Details about its classification (Class II), product codes, and applicable regulations.
• Indications for Use: What the device is intended to measure (blood pressure, cardiac output, EEG signals with BIS Module, continuous non-invasive arterial blood pressure with CNAP Module, etc.) and where it is intended to be used.
• General Controls: Mentions general controls like annual registration, listing, good manufacturing practice, and labeling.

It does not describe:

• Acceptance criteria in a quantitative sense (e.g., specific metrics like accuracy, sensitivity, specificity, AUC).
• A "study" with a test set, training set, ground truth, experts, or statistical analysis.
• Any mention of AI, machine learning, or algorithms that would require such a study as per your request parameters.
• Any comparative effectiveness studies with or without human-in-the-loop for an AI component.

Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document that details the validation study of an AI/ML medical device.

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