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Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical grade PC physically mounted to the Anesthesia Delivery System and receives data from supported Anesthesia Delivery Systems, Anesthesia Patient Monitors and Intravenous Drug Infusion Pumps.

Navigator Therapy displays pharmacokinetic, pharmacodynamic (PK/PD) and synergistic PD modeling information. Navigator Therapy provides the heath care provider with information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.

Models only apply to the following patient populations:

Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient.

Navigator Protocol allows facilities to load electronic versions of care protocols. This feature can be configured with selected patient monitoring parameters available for viewing in conjunction with the care protocol.

Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information.

The system is designed for facility use and should only be used under the orders of a clinician.

The Navigator Applications Suite is a product that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. It works in a standalone or networked environment. The three main functions of the Navigator are:

• . Navigator Therapy: Visualization of the modeled effect of the anesthesia drugs on the patient displayed on a point-of-care Navigator computer. The visualization is based on pharmacokinetic and pharmacodynamic (PK/PD) models and multi-drug models. Navigator also supports automatic data capture from supported intravenous drug infusion pumos and patient monitors to minimize manual data entry
• • Navigator Protocol: Framework to enable access to facility-selected care protocols at the point of care.
• . Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

This is a 510(k) premarket notification for the Navigator Applications Suite. The device is a software package that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. It has three main functions: Navigator Therapy, Navigator Protocol, and Navigator Device. The submission is for an updated version of the Navigator Applications Suite, which includes new multi-drug models for inhaled agents and expands the number of multi-drug models available in the system.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) and corresponding reported performance metrics directly related to the new features (inhaled anesthetic models, expanded multi-drug models).

The "acceptance criteria" appear to be compliance with established medical device standards and demonstrating usability in a clinical setting, rather than specific performance metrics for the predictive models themselves.

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

The document states, "Additional testing of the Navigator Applications Suite was performed in a clinical setting to demonstrate the usability of the device."

• Sample Size for Test Set: The exact sample size for this clinical usability testing is not specified in the document.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "a clinical setting," which implies prospective data collection during the usability study.

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

The document focuses on "usability" in a clinical setting. It does not mention the use of experts to establish a "ground truth" in the context of the predictive models for the test set. For a usability study, the "experts" would typically be the clinicians using the device, and their feedback on usability would be the "ground truth." However, no specific details on the number or qualifications of these clinicians are provided.

4. Adjudication Method for the Test Set

As the document describes clinical usability testing and not a performance study requiring ground truth for predictive model accuracy, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study to measure reader improvement with AI assistance was not done or mentioned in this submission. The focus was on demonstrating usability and compliance with standards for a device that provides predictive model information, not on improving human reader performance.

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

The core functionality of the Navigator Applications Suite, specifically Navigator Therapy, is a standalone algorithm that displays pharmacokinetic and pharmacodynamic modeling information. The models themselves calculate and predict values. The document states, "Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient." This indicates that the algorithm's predictions are a standalone output.

However, the "clinical testing" described was for "usability" of the device in a clinical environment, meaning it involved human interaction, but not a standalone performance study in the sense of validating the algorithm's predictive accuracy against measured patient outcomes. The foundational models are "published models," implying their standalone performance was established prior to their integration into this device.

7. The Type of Ground Truth Used

For the predictive models: The document states, "Calculated drug concentrations and effects are based on published models." This implies that the ground truth for these models is derived from established scientific literature and research.

For the usability study: The "ground truth" would be the observed user interactions, feedback, and assessment of whether the device was usable and did not introduce hazards, rather than a specific medical "ground truth" (like pathology or outcomes data).

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The predictive models are based on "published models," which means they were developed using existing data sets (pharmacokinetic and pharmacodynamic studies) that are not detailed in this submission. This is not a de novo AI model trained from scratch with new data for this submission.

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

Since the models are based on "published models," the ground truth for their original development would have been established through extensive pharmacokinetic and pharmacodynamic research, including clinical trials and observational studies that measured drug concentrations, physiological effects, and patient responses. These methods are not detailed in this 510(k) submission, as the models themselves are externally sourced and established.

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