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The intended use of the Mercury module with Capnostat 5 is to provide:

• 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.

The Mercury module with Capnostat 5 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 in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.

This document describes a Special 510(k) for a device modification, specifically an increase in the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM on the Mercury Module with Capnostat 5 CO2 sensor. The submission asserts that the device is "identical" to the predicate device except for this specification change, which was made to align with maximum inspiratory flow for ventilators cleared for use with neonates.

Because this is a Special 510(k) for a minor modification, the typical structure of a comprehensive de novo submission with detailed performance studies and acceptance criteria as outlined in your prompt is not present. Special 510(k)s often rely on demonstrating that the change does not significantly affect safety or effectiveness, often by showing that the modified device still meets existing performance standards or by providing limited testing related only to the change.

Therefore, many of the specific details you requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for a full-scale AI/ML device validation are not available in this type of submission.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

Acceptance Criteria and Device Performance Study (K092217)

This submission is a Special 510(k) for a minor modification to an existing device (Mercury Module with Capnostat 5 CO2 sensor). The modification involves increasing the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM. This type of submission relies on demonstrating substantial equivalence to a predicate device and that the change does not significantly affect safety or effectiveness.

Due to the nature of this submission (a device modification rather than a new device), the provided text does not contain explicit performance acceptance criteria or detailed study results in the manner one would expect for a novel AI/ML device. Instead, the focus is on the equivalence to the predicate device and the justification for the specification change.

The primary "acceptance criterion" for this Special 510(k) appears to be that the modified device remains substantially equivalent to the cleared predicate device (K080652) and that the change aligns with existing standards for neonatal ventilators.

Based on the provided text, a formal "study" with specific performance metrics and statistical analyses (as would be typical for an AI/ML product) is not described. The manufacturer states that the device is "identical" except for the changed specification.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this Special 510(k), explicit performance acceptance criteria are not detailed in the provided text. The "acceptance" is implied by the FDA's decision of substantial equivalence.

The following points cannot be answered definitively from the provided text as it pertains to a hardware device modification, not an AI/ML algorithm requiring such specific validation details.

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

• Not Applicable/Not Provided: For a hardware modification like this, a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient records) is not relevant. The testing would involve verifying the hardware's performance characteristics. Details on such testing (e.g., number of units tested, conditions) are not in this summary.

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

• Not Applicable/Not Provided: Ground truth in the AI/ML sense (e.g., expert labels for clinical conditions) is not relevant for this hardware modification. The "ground truth" for the modified specification would likely be established through engineering design, material specifications, and performance verification against known physical standards, rather than expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable/Not Provided: This method is used in AI/ML studies to resolve discrepancies in expert annotations. It is not relevant to the validation of a hardware device's technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• Not Applicable/Not Provided: MRMC studies are specific to evaluating clinical performance of AI/ML tools used by human readers. This submission concerns a physical sensor's performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable/Not Provided: This pertains to AI/ML algorithm performance independent of human interpretation. It is not relevant for a hardware sensor.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable/Not Provided: The "ground truth" for this device's performance would likely be based on physical measurements against calibrated standards, engineering specifications, and established physiological ranges for neonatal respiration, rather than clinical consensus, pathology, or outcomes data in the AI/ML context.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: "Training set" refers to data used to train an AI/ML model. This device is a hardware sensor, not an AI/ML algorithm.

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

• Not Applicable/Not Provided: As above, this concept refers to AI/ML model development and is not applicable to this hardware device modification.

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The intended use of the Mercury module with Capnostat 5 is to provide: 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.

The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intention norminds for monthsive non emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the flow and carbon dioxide monitoring component of the NICO monitor. The Mercury module with Capnostat 5 is the flow and carbon dioxide monitoring component of the presently 510(k) cleared NICO with MARS monitor. It has been designed to include all of the functionality of the flow and carbon dioxide monitoring components of NCO with CO massurament workilling for a with Capnostat 5 is intended to provide all of the existing flow and CO2 measurement capabilities of the NICO Model 7300 of continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostal 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Mercury Module with Capnostat 5 CO2 Sensor, primarily focusing on its substantial equivalence to a predicate device and its intended use. It does not detail specific performance studies, acceptance criteria, or the methodology for proving these criteria.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details based on the provided text.

Ask a specific question about this device