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The CARTO® ENT System is intended for use during intranasal image-guided navigation procedures for patients who are eligible for sinus procedures.

The CARTO® ENT System is intended as an aid for precisely locating anatomical structures during intranasal and paranasal image-guided navigation procedures.

The CARTO® ENT System is intended to be used during intranasal and paranasal surgical procedures to help ENT physicians to track and display the real-time location of the tip of navigated instruments relative to pre-acquired reference images, such as CT. The CARTO® ENT device enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology. The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, Workstation and accessories. A magnetic field generated by the Field Ring induces a current in the magnetic sensor embedded in the tip of the flexible navigated tool, which helps to accurately calculate the tool tip position. A CT image is imported and registered to the patient coordinates and a tool tip icon is displayed on top of the registered image, indicating the position of the tool in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the navigation procedure.

The CARTO ENT System is an image-guided surgery system. The information provided describes the acceptance criteria and study proving its performance.

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

The document does not specify an exact "test set" sample size or data provenance in terms of country of origin or whether it was retrospective or prospective for the accuracy tests.

• Bench Test Location Accuracy: The test involved comparing the CARTO® ENT System's electromagnetic locations to those provided by a "very accurate robot system over the entire navigation volume." No specific sample size (e.g., number of measurements) is given.
• Simulated Use Accuracy: This involved performing "a complete CT image registration and instrument navigation workflow." Again, no specific sample size (e.g., number of simulated procedures or measurements) is provided.
• Pre-clinical (cadaver) tests: These were conducted to mimic surgical procedures "in a simulated clinical environment." No sample size (number of cadavers or procedures) is specified.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not provided. The accuracy tests rely on a "very accurate robot system" for bench accuracy and the overall system workflow for simulated use, rather than expert-established ground truth in the traditional sense of medical image interpretation. For pre-clinical cadaver tests, qualitative estimation of clinical accuracy was performed, but no details on expert involvement or qualifications are given.

4. Adjudication method for the test set

This information is not explicitly provided. Given the nature of the bench and simulated use accuracy tests (comparison to a robot system or workflow performance), an "adjudication method" as typically applied in human reader studies would not be directly applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC comparative effectiveness study was not done. The document states, "Clinical data was not necessary for the CARTO® ENT System."

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

Yes, the performance tests described (Bench test location accuracy, Simulated Use Accuracy) primarily evaluate the device's intrinsic capabilities and accuracy as an algorithm/system standalone. While a human operates the system during simulated use, the focus is on the system's ability to track and display positions accurately. The "pre-clinical (cadaver) tests" involved a human performing a sinuplasty procedure workflow, but the evaluation of "system clinical accuracy" was qualitative, and the primary accuracy metrics come from controlled technical tests.

7. The type of ground truth used

• Bench test location accuracy: Ground truth was established by a "very accurate robot system."
• Simulated Use Accuracy: Ground truth seems to be derived from the "complete CT image registration and instrument navigation workflow" itself, implying a reference standard within the controlled simulation.
• Pre-clinical (cadaver) tests: The "ground truth" for these tests was for "qualitatively estimate the system clinical accuracy" rather than a defined, measurable anatomical truth.

8. The sample size for the training set

This information is not provided. The document describes a medical navigation system, and while it involves software, there's no mention of an "algorithm training set" in the context of machine learning, which is typically where a training set sample size would be relevant. The system's functionality is based on electromagnetic tracking technology, not explicitly on a learned model from a training data set described here.

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

This information is not provided as a "training set" is not mentioned in the context of this device's validation.

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