(82 days)
The Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube 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, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures
The Cube Navigation System is an image guided surgery system, visualizing instrument positions on 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, called navigation sensor within the Cube navigation system. 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 surface matching performed by the user either tactile using an navigated instrument or non-tactile using the registration device VituEye. Thereafter the spation of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.
The provided text is a 510(k) Summary for the Fiagon Cube Navigation System. It details the device's technical specifications, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a full clinical study with acceptance criteria and detailed performance of an AI-driven vision system.
Therefore, the document does not contain the specific information requested regarding acceptance criteria related to AI performance, sample sizes for test sets (beyond general bench testing), data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone algorithm performance, or ground truth establishment for training and test sets in an AI context.
The document primarily focuses on the device's accuracy as a navigation system, but this is a mechanical/electrical performance metric, not an AI diagnostic performance metric.
However, I can extract the relevant acceptance criterion and the reported performance for the device's accuracy:
Acceptance Criteria and Reported Device Performance (as related to accuracy):
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Position Mean |
§ 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).