(303 days)
The Fiagon Navigation System is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
Cranial Procedures:
- Craniotomies/Craniectomies (e.g., Tumor Resection)
- Skull Base Procedures
- Cranial Biopsies
- General Catheter Shunt Placement
- Pediatric Catheter Shunt Placement
The user should consult the "Bench Accuracy" section of the User Manual to assess whether the accuracy of the system is suitable for their needs.
The Fiagon Navigation System displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The instrument with integrated sensor and the patient equipped with 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 is updated with a rate of 15 to 45 Hz.
The components of the navigation system are
- Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 – 4 below.
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- Navigation sensor (Headrest with field generator)
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- Navigation instrument (ShuntPointer, BiopsyPointer190 and BiopsyPointer 250)
- Patient reference localizer (Localizer Set Bone Anchor and Localizer Adhesive Pad)
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) are 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 includes the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient localizer and the navigation instrument.
The 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 patient's anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy.
The provided text describes the Fiagon Navigation System, a stereotaxic instrument used as an aid for locating anatomical structures in neurosurgical procedures. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices, rather than a standalone AI-driven diagnostic system. As such, many of the requested elements pertaining to AI model validation, such as training set details, multi-reader multi-case studies, and expert consensus for ground truth, are not applicable to this type of medical device submission.
The document primarily details bench testing to assess the accuracy of the navigation system.
Here's an breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device appear to be implicitly defined by demonstrating accuracy similar to predicate devices. The key performance metrics are Target Registration Error (TRE) and Angular Registration Error (ARE).
| Performance Metric | Acceptance Criteria (Implied: similar to predicate) | Reported Device Performance (Localizer Set Bone Anchor) | Reported Device Performance (Localizer Adhesive Pads) |
|---|---|---|---|
| Target Registration Error (TRE) |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).