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The intended use of the CO2,SMO Plus! with NICO 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, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate flow sensors and CO2 airway adapters are provided for pediatric/adult and neonatal use.

It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician.

It is intended that:

• the neonatal flow and combined CO /flow sensors be used with ET tube sizes less . than or equal to 4 mm and
• the pediatric/adult flow and combined CO2/flow sensors be used with ET tube sizes # greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece.

The fittings of the flow sensors and CO2 airway adapters comply with ISO [5356-1: 1987 (E)].

The flow sensors and CO2 airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification.

The flow sensors, combination CQ2fflow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices.

The CO2SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance.

The use of the CO2SMO Plus! with NICO is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.

Not Found

This FDA 510(k) clearance letter for the Novametrix Medical Systems, Inc. CO2SMO Plus! With NICO device does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a regulatory clearance letter, which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the "Indications For Use" but does not describe specific performance metrics, acceptance criteria, or the methodology of a study to demonstrate these.

To fully answer your request, here's a breakdown of what's missing and why it cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the summary of the 510(k) submission itself, often in sections detailing device performance data or clinical validation. The clearance letter only states that the device is "substantially equivalent" to a predicate, implying that its performance is deemed acceptable based on comparison to existing devices. It does not provide the specific performance values or the criteria against which they were measured.

2. Sample size used for the test set and the data provenance: This level of detail would be in the study design section of the 510(k) submission, not the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As with sample size, this is part of the study design information, absent from this document.

4. Adjudication method: Not present in this regulatory letter format.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study information: This type of study detail would be in the clinical or performance data section of the 510(k) submission. Given the device (CO2SMO Plus! with NICO for physiological monitoring), it's less likely to involve a comprehensive MRMC study in the way an imaging AI algorithm would.

6. Standalone performance: While the device functions as a "standalone" monitor, the performance study demonstrating its accuracy in a standalone mode, with specific metrics, is not detailed here. The letter only approves the device for marketing.

7. The type of ground truth used: This would be specific to each parameter being measured (e.g., CO2 values correlated with blood gas analysis, cardiac output against a gold standard method). This information is not in the clearance letter.

8. Sample size for the training set: This device is a physiological monitoring system, not an AI/ML algorithm that undergoes a "training" phase in the typical sense (unless it incorporates some adaptive algorithm, which is not mentioned). Therefore, a "training set" as understood for AI is unlikely to be relevant here, or if it were, the details would be in the detailed submission.

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

In summary: The provided document is an FDA 510(k) clearance letter. Its purpose is to inform the manufacturer that their device has been found substantially equivalent to a predicate and can be legally marketed. It meticulously avoids detailing the specific study results, acceptance criteria, or ground truth establishment methods, as those are contained within the full 510(k) submission document, which is a much more extensive technical dossier.

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