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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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The intended use of the NICO monitor, Model 7300 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 monitor Model 7300 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 monitor Model 7300 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. As is its predicate device CO2SMO Plus! with NICO, NICO with MARS is designed to use neonatal, pediatric, and adult combined CO2/flow sensors and single patient use or reusable pulse oximetry sensors. It non-invasively calculates cardiac output using established physiological principles by the application and removal of a rebreathed volume in a patient's breathing circuit and the analysis of that response. The NICO with MARS is intended to provide cardiac output monitoring in mechanically ventilated patients in the operating room and intensive care units. It is intended to serve the same purposes as the CO2SMO Plus! with NICO and MARSPO2, Model 2001.

Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. As the Model 2001 monitor, the Model 7300 with MARS consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The Model 7300 can be powered by either an internal power supply operating on AC or by a sealed rechargeable lead-acid gel battery. Audible and visual alarms for high/low saturation and pulse rate are available. There is also a serial port that provides user configurable data output capable of communicating with printers and other devices.

Here's an analysis of the provided text regarding the NICO, Model 7300, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, specific acceptance criteria and detailed study results demonstrating performance against these criteria are not explicitly stated or fully detailed. The document primarily focuses on establishing substantial equivalence to predicate devices and describes the device's technological characteristics and intended use.

However, it does mention a specific study for pulse oximetry accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical acceptance criteria. The "Reported Device Performance" is inferred from the description of the study and the claim of meeting specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Pulse Oximetry Accuracy: The document states "controlled hypoxia studies were conducted." It does not specify the sample size (number of subjects) for these studies.
• Data Provenance: The studies were evidently conducted by Respironics Novametrix Inc., likely in the USA (where the company is based). The studies were conducted prospectively for the purpose of demonstrating the device's accuracy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth would likely be established using a co-oximeter or arterial blood gas analysis, which are considered gold standards, overseen by clinical professionals.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not mentioned or described. This document does not describe studies comparing human readers' performance with and without AI assistance. The device is a monitor, not an AI-assisted diagnostic tool for human interpretation in the sense of image reading.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed for the pulse oximetry component. The "controlled hypoxia studies" were designed to establish the accuracy of the Model 7300's pulse oximetry function and its integrated sensors. This implies assessing the algorithm's performance in measuring oxygen saturation against a known reference in a controlled environment. The document also mentions the "firmware for the second microprocessor... performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction." This directly points to evaluating the algorithm's output.

7. Type of Ground Truth Used

• For pulse oximetry, the ground truth for the "controlled hypoxia studies" would typically be established using a co-oximeter to measure arterial oxygen saturation (SaO2) from arterial blood samples. This is considered the clinical gold standard for arterial oxygen saturation.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. While the pulse oximetry algorithms use "existing algorithms" and mention "additional calculations which analyze the incoming signals and perform noise reduction," there is no mention of a distinct training phase or a specific dataset used for training machine learning models in the context of this 2003 submission. The algorithms are likely based on established physiological principles and signal processing, rather than modern data-driven machine learning with explicit training sets as understood today.

9. How the Ground Truth for the Training Set Was Established

• As a training set is not explicitly mentioned in the context of modern machine learning model development, the method of establishing ground truth for a training set is not applicable/not provided in this document. The underlying principles and parameters for the device's algorithms (e.g., ratiometric technique for O2 saturation) are based on fundamental scientific understanding rather than a data-driven training process.

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