(252 days)
The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.
Geniant Cranial is a hardware platform that supports real-time surgical navigation using medical patient images. The application software reprocesses the CT or MR images of the patient acquired before surgery. It displays the contents on the software screen in various fluoroscopy directions (axial, sagittal and coronal). Before surgery, the surgeon can create and save one or more surgical routes to simulate. The surgeon may create and manipulate one or more 3D models of human anatomy before the surgery. During surgery, the system tracks the position of special surgical tools in the patient's anatomy and continuously updates the positions of the surgical tools in these images. The application software can also show you how the actual position and path during surgery relate to the pre-operative plan and guide the surgeon to follow the planned trajectory. The real-time location information obtained through Genial can help guide the surgeon's decision and the surgical route.
This document describes the acceptance criteria and the study proving the device meets them for the "Geniant Cranial (Navigated Neurosurgical Positioning Robot)".
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from Predicate Device #2) | Reported Device Performance (Geniant Cranial) |
|---|---|---|
| 3D Positional Accuracy (mean error) | ≤ 2.0 mm | ≤ 1.5 mm |
| Trajectory Angle Accuracy (mean error) | ≤ 2.0 degrees | ≤ 2.0 degrees |
Detailed Performance Results for Geniant Cranial:
| Applied registration method | Positional Accuracy (mm) (Mean) | Positional Accuracy (mm) (99% CI Upper Bound) | Trajectory Angle Accuracy (degrees) (Mean) | Trajectory Angle Accuracy (degrees) (99% CI Upper Bound) |
|---|---|---|---|---|
| Paired Point Registration (PPR) | 0.766 | 1.616 | 0.264 | 0.678 |
| Bone Fiducial Registration | 0.916 | 1.907 | 0.292 | 0.750 |
| Tracing Registration | 0.872 | 1.849 | 0.334 | 0.860 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the accuracy testing. It states that "Koh Young Technology considered all parameters that may influence the stereotactic procedure, which include the different devices, accessories, and components of Geniant Cranial, other influencing devices used in the procedure that are validated to be compatible with Genial, and other elements of the surgical environment" and that the testing was performed "Under the representative worst-case configuration considering an actual clinical procedure".
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin. However, given that these are non-clinical performance and accuracy tests, the data likely originates from internal lab testing conducted by the manufacturer, Koh Young Technology Inc. (Republic of Korea).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the non-clinical accuracy test set. As this is a non-clinical, performance-based test measuring instrument accuracy, the ground truth would likely be established through precise metrological measurements rather than human expert interpretation of medical images.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method as it pertains to clinical interpretation or consensus. The described testing is a technical accuracy assessment, and thus, typical clinical adjudication methods (like 2+1, 3+1) are not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance. The device is a "Navigated Neurosurgical Positioning Robot," which falls under the category of surgical navigation systems and is not an AI-assisted diagnostic imaging interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The accuracy testing detailed in "Table 3 – Accuracy Testing Result" presents the inherent accuracy of the Geniant Cranial device itself (robot and navigation system) in simulating spatial positioning and trajectory guidance. This testing measures the device's ability to achieve specific positional and angular accuracy independent of a human operator's varying performance, by comparing its output against a known, precise "ground truth" established during the test setup.
7. Type of Ground Truth Used
The ground truth used for the accuracy studies was established through precise physical measurements to determine the true 3D positional and trajectory angle targets. These are technical benchmarks for device performance, not clinical pathology or outcomes data. The study references "ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems" and "ISO 9283:1998 Manipulating industrial robots - Performance criteria and related test methods," indicating that the ground truth was based on metrological standards for robotic and computer-assisted system accuracy.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. As this device is a surgical navigation robot and not a machine learning/AI diagnostic tool that requires image-based training, the concept of a "training set" in the context of data-driven algorithm development for image interpretation is not directly applicable here. The device's functionality is based on real-time tracking, image reprocessing, and robotic guidance, relying on established geometric and kinematic principles rather than statistical learning from a large training dataset.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the document does not indicate the use of a "training set" in the context of machine learning. The device's operational principles rely on precise engineering and calibration rather than data-driven training. Therefore, the establishment of ground truth for a training set is not discussed or relevant to the reported performance evaluation.
§ 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).