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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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