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The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures

The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching,

Thereafter the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

The components of the navigation system are

1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
2. Navigation sensor (Headrest with field generator)
3. Navigation instrument,
4. Patient reference localizer (with fixation material) :

The navigation unit, is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM, USB storage media or LAN network and displayed in appropriate way (defined by the software)

The navigation unit compromises as well the spatial measuring device electronics. This has connections to the field generating device (navigation sensor), the patient localizer and the navigation instrument.

Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.

The patient reference localizer is fixed to the patients anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy.

Here's a summary of the acceptance criteria and study details for the Fiagon Navigation System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and data provenance:

   • Sample Size: Not explicitly stated in terms of number of cases or patients. The document refers to "bench accuracy" and "clinical accuracy" without providing the sample size for these measurements.
   • Data Provenance: Not explicitly stated. The study appears to be part of the regulatory submission from Fiagon GmbH, a German company, so it's likely the testing occurred in Germany, but this is not confirmed. The document only mentions "Bench testing was conducted" and "Reported mean clinical accuracy," implying these were done by the manufacturer. Retrospective or prospective nature is not specified, but typically performance testing for regulatory submission is prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here relates to physical measurements of accuracy and distortion, not expert consensus on medical images or diagnoses.

3. Adjudication method for the test set: Not applicable, as the data are objective measurements of physical accuracy.

4. 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 device is not an AI/ML-driven diagnostic tool involving human readers; it's an image-guided surgery system. The "AI" in "AI vs without AI assistance" does not apply to this context.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, a standalone performance assessment was done. The "bench testing" and "mean clinical accuracy" reported refer to the inherent accuracy of the device itself in localizing instruments, rather than its performance integrated with human interpretations or decision-making.

6. The type of ground truth used:

   • For bench accuracy, the ground truth would be precise, metrological measurements of known physical locations from a reference standard.
   • For field distortion detection, the ground truth would be controlled induction of electromagnetic field distortions and measurement of when the device detects them.
   • For clinical accuracy, the ground truth would be precise measurements of instrument tip positions relative to anatomical structures, likely through comparison with highly accurate imaging or fiducial markers.

7. The sample size for the training set: Not applicable. This device is an image-guided surgery system based on electromagnetic tracking technology, not a machine learning model that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this type of device.

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