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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 mounted on or near the anesthesia delivery system and receives data from supported anesthesia delivery systems, anesthesia patient monitors, intravenous drug infusion pumps and/or electronic record keeping systems.

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

The theoretical models are for 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 is not intended to be the sole source for patient specific guidance on clinical decisions, including dosing decisions for anesthetic drugs. Always refer to the appropriate drug labeling for dosing information and quidance.

Navigator Protocol allows hospitals 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 providing access to certain anesthesia delivery system alarm information.

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

The Navigator Applications Suite is a software product that runs on a medical grade computer and 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 medical grade 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 pumps and patient monitors to minimize manual data entry.
• Naviaator 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.

Here's an analysis of the provided text regarding the Navigator Applications Suite, structured to address your specific points.

Acceptance Criteria and Device Performance Study

The provided document (510(k) summary K102389 for the Navigator Applications Suite) does not contain explicit acceptance criteria or a dedicated study proving performance against them in the traditional sense of a clinical or analytical performance study of an AI/ML device.

This submission is a 510(k) for a software update (Version 3) of an existing device. The core argument for substantial equivalence relies on:

1. No significant changes to intended use or fundamental scientific technology.
2. Software re-write for performance and UI improvements.
3. Compatibility with additional patient monitors and IV pumps.
4. Minor wording clarifications to the intended use and emphasis on the theoretical/advisory nature of the device.
5. Previous versions (K071097, K081941, K083098) serving as predicates.

Therefore, instead of a table of acceptance criteria and reported device performance through a new clinical study, the document emphasizes nonclinical testing for verification of specifications and validation, including software validation, and compliance with standards. The key conclusion is that "The modifications made to the Navigator Applications Suite did not require clinical testing to demonstrate the safety and effectiveness of the updated device."

Given this, I will answer the questions based on the information provided, highlighting what is (and isn't) present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit acceptance criteria and corresponding reported device performance from a new study are not detailed in this 510(k) summary. The document states that the device was updated from a predicate and underwent nonclinical testing.

The "performance" described is largely about the software's functionality and compatibility, rather than a clinical performance metric against a gold standard.

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

Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a "test set" of patient data for the updated device in the context of AI/ML evaluation. The assessment of the device's efficacy relies on its substantial equivalence to previously cleared predicates and non-clinical software validation.

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

Not applicable/Not provided. Since there was no clinical "test set" requiring ground truth establishment, this information is not relevant to this submission. The device provides "theoretical information about the modeled effect" and "is not intended to be the sole source for patient specific guidance on clinical decisions."

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set with an adjudication method is described.

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

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) submission. The device is not positioned as an AI-assisted diagnostic or decision support tool that co-interprets with human readers in a way that typically necessitates an MRMC study to measure improved reader performance. It provides "theoretical information" and "advisory" data.

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

Partially Yes, in a limited context. The device is an "algorithm" (using PK/PD models) that provides information. However, the performance validation described is "software validation" and "verification of specifications," rather than a standalone clinical performance study comparing the algorithm's output to a clinical ground truth. The device's output (calculated concentrations and effects) is always theoretical and stated to not be the "sole source for patient specific guidance." Its standalone performance is thus evaluated in terms of its computational accuracy based on published models and software integrity, not an independent assessment of clinical utility (which is explicitly disclaimed).

7. The Type of Ground Truth Used

Mathematical Models/Published Data. For the core function of Navigator Therapy (PK/PD modeling), the "ground truth" for the calculations is based on "published models." The document explicitly 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 software's accuracy is validated against the proper implementation and output consistency with these established mathematical models.

For Navigator Protocol and Navigator Device features, the "ground truth" would relate to the correct display of facility-selected care protocols and accurate troubleshooting information for anesthesia delivery systems, likely validated through functional testing against source documents.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device utilizes pharmacokinetic and pharmacodynamic models, which are generally based on physiological research and mathematical derivations, not typically "trained" on large datasets in the way modern machine learning models are. The models themselves are "published models." Therefore, a "training set" in the AI/ML sense is not relevant for this device.

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

Not applicable/Not provided. As explained above, a "training set" is not applicable in the context of this device's technological basis. The models used are established scientific models from published literature.

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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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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. 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 for propofol and four analgesic drugs. Navigator also supports automatic data capture from supported intravenous drug infusion pumps to minimize manual data entry.
• Navigator Protocol: Framework to enable access to facility-selected care protocols at the . point of care.
• t Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.

The Navigator Applications Suite has been modified to work in a network environment.

This document (K081941) is a 510(k) Premarket Notification for the Navigator Applications Suite, a software package that integrates information from an anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. The notification focuses on modifications to the device to work in a network environment, with no changes to the intended use or fundamental scientific technology. Therefore, the information provided primarily concerns non-clinical testing for safety and compliance with standards, rather than clinical performance or AI-specific validation.

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

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because the submission is for a modification that doesn't alter core functionality or intended use. Instead, the acceptance criteria are implicitly tied to compliance with relevant medical device standards and software validation.

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. The testing described is primarily non-clinical, focusing on software verification and validation, and compliance with standards. Therefore, information on sample size, data provenance, or retrospective/prospective studies is not applicable or provided.

3. 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)

This information is not provided as the submission concerns non-clinical testing and regulatory compliance for a software modification, not a clinical performance study requiring expert ground truth.

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

Not applicable, as no clinical test set requiring adjudication is described.

5. 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

Not applicable. This submission is for a medical device software that provides information and tools (PK/PD modeling, protocols, troubleshooting) for anesthesia management, not an AI-based diagnostic or assistive tool that would typically involve a multi-reader multi-case study to evaluate human reader improvement. The "AI" aspect here (PK/PD modeling) is based on published models, not machine learning trained on images or diagnostic data.

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

The Navigator Applications Suite, particularly the Navigator Therapy component, contains algorithms (pharmacokinetic and pharmacodynamic models). The document states: "Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient." and "Drug models are calculated and displayed assuming a healthy patient." This indicates that the algorithms operate in a "standalone" computational manner based on pre-defined models. However, the output is "displayed" to a healthcare provider, implying a human-in-the-loop for interpretation and clinical decision-making. The "standalone performance" in this context would refer to the accuracy of the model calculations based on inputs, which is implicitly validated by the software testing and reliance on "published models." Specific metrics for this standalone performance are not provided beyond the general statement of "thoroughly tested through verification of specifications and validation."

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

For the PK/PD models, the "ground truth" is implied to be published pharmacokinetic and pharmacodynamic models. The software's validation would focus on correctly implementing these models and calculations. For the other functionalities (Protocol and Device), the "ground truth" would relate to the correct display of protocols and troubleshooting information, which is validated through software testing against design specifications.

8. The sample size for the training set

Not applicable. The device's "AI" component (PK/PD modeling) is based on published mathematical models, not on a machine learning approach requiring a training set of data.

9. How the ground truth for the training set was established

Not applicable, as no training set (in the machine learning sense) is mentioned. The ground truth for the underlying PK/PD models would have been established through extensive prior research, clinical trials, and scientific consensus leading to their publication. The device uses these established models rather than training its own.

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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 o product that integrates information from a anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. 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 phormacokinetic and pharmacodynamic (PK/PD) models and multi-drug models for propofol and four analgesic drugs. Novigator also supports automatic data capture from supported intravenous drug infusion pumps 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.

The provided text is a 510(k) Premarket Notification for the "Navigator Applications Suite." It describes the device, its intended use, and its similarities and differences to predicate devices for the purpose of demonstrating substantial equivalence.

However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria. The 510(k) summary focuses on general company information, device description, intended use, and comparison to predicate devices, as required for regulatory submission. It does not include specific performance data, clinical study results, or a detailed breakdown of acceptance criteria as would be found in a performance testing report or clinical trial summary.

Therefore, I cannot extract the requested information as it is not present in the provided text. The tables for acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are all absent from this document.

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