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The intended use of the NICO with MARS, Model 7300, monitor is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).

The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO2 level cannot be tolerated.

The NICO with MARS, Model 7300, is a patient monitor capable of monitoring a patient's cardiac output, spirometry, carbon dioxide, and functional oxygen saturation and pulse rate. In addition, the Model 7300 is capable of communicating with a variety of patient information systems, including the Respironics Esprit ventilator.

The provided text describes a special 510(k) submission for a device modification, specifically an interface for the NICO with MARS, Model 7300 monitor to communicate with the Respironics Esprit ventilator. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance in the same way a new device might.

Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth are not present or not directly applicable in this specific regulatory submission. The document mainly outlines the device's intended use, technological characteristics, and compares it to a predicate device (K030886 - NICO with MARS, Model 7300).

However, I can extract the information that is present and indicate where the requested information is not available from the provided text.

Acceptance Criteria and Device Performance:

The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, precision) for the communication interface. Instead, the "acceptance" is based on the demonstration of substantial equivalence to a predicate device, meaning the modified device performs as intended without raising new questions of safety or effectiveness.

The "reported device performance" in this context refers to the inherent performance of the NICO with MARS, Model 7300, for which the communication interface is being added. The document reiterates its original intended uses and technological characteristics.

• Cardiac output via partial rebreathing in adult patients mechanically ventilated during general anesthesia and in ICU.
• Spirometric and CO2 monitoring in neonatal, pediatric, and adult patients during general anesthesia, ICU, and ED.
• Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric, and adult patients during no motion and motion conditions, and for well or poorly perfused patients during general anesthesia, ICU, and ED.

The monitor uses:

• Flow sensors and pneumatics for flow measurement (proportional to pressure drop).
• Infrared absorption (IR) technique for CO2 monitoring.
• Red and infrared light sources in sensors for oxygen saturation and pulse rate (plethysmogram and MARS technology's frequency-based algorithm).
• Non-invasive differential Fick partial re-breathing technique for cardiac output.
• Bidirectional serial communications (ASCII/scaled binary digits) and analog outputs for external devices, including Respironics Esprit Ventilator. |
  | No new questions of safety or effectiveness are raised. | The submission states: "The NICO with MARS, Model 7300, monitor with NICO to Esprit Communications Interface has the same intended use as the predicate monitor [K030886]." This implies that the safety and effectiveness profile is maintained. |

Here's a breakdown of the other requested information based on the provided document:

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided. This document describes a 510(k) for a device modification, specifically a communication interface. It does not mention a clinical test set or data from a study to establish performance for this particular modification. The focus is on demonstrating substantial equivalence to the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable / Not provided. Since no specific test set or clinical study data is presented for this modification, there's no mention of experts establishing a ground truth for such a set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a medical monitoring device, not an AI-assisted diagnostic tool. No MRMC study or AI components are mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device integrates with human operation as a monitor. The "standalone" performance would refer to the device's function in monitoring, which is described in its technological characteristics, but not as an "algorithm only" in the context of AI. The communication interface itself is a technical component, not a standalone algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable / Not provided for this modification. For the original device, performance would likely have been validated against established reference methods for cardiac output, CO2, spirometry, and pulse oximetry, but this detail is not in the provided modification summary.

7. The sample size for the training set:

   • Not applicable / Not provided. The device does not appear to use machine learning in a way that would require a "training set" in the context of AI development.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided.

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