(99 days)
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- Functional Endoscopic Sinus Surgery (FESS)
- Endoscopic Skull Base procedures
- Lateral Skull Base procedures
The Medtronic SteathStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
The StealthStation FlexENT™ is an electromagnetic based surgical guidance platform that supports use of special application software (StealthStation™ S8 ENT Software 1.3 and associated instruments.
The StealthStation™ S8 ENT Software 1.3 helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. StealthStation™ S8 ENT Software 1.3 functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and traiectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, realtime positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide. The StealthStation™ S8 ENT v1.3 Software can be run on both the StealthStation FlexENT™ and StealthStation™ S8 Platforms.
The StealthStation™ System is an Image Guided System (IGS), comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (mean error) | Reported Performance (StealthStation FlexENT™) | Reported Performance (StealthStation™ S8) | Reported Performance (Predicate: StealthStation™ S8 ENT v1.0) |
|---|---|---|---|---|
| 3D Positional Accuracy | ≤ 2.0 mm | 0.93 mm | 1.04 mm | 0.88 mm |
| Trajectory Angle Accuracy | ≤ 2.0 degrees | 0.55° | 1.31° | 0.73° |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Testing was performed under the representative worst-case configuration... utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." It does not specify a numerical sample size for the test set (e.g., number of phantoms or trials).
The data provenance is not explicitly stated in terms of country of origin. The test appears to be a prospective bench study conducted by the manufacturer, Medtronic Navigation, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for this accuracy testing. The ground truth for positional and trajectory accuracy would typically be established by precise measurements on the anatomically representative phantoms using highly accurate measurement systems, not by expert consensus.
4. Adjudication Method for the Test Set:
Not applicable, as this was a bench accuracy test with directly measurable metrics, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not conducted. The study focuses on the standalone accuracy of the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance study was done. The accuracy testing described ("3D positional accuracy" and "trajectory angle accuracy") measures the device's inherent accuracy in locating anatomical structures and guiding trajectories, independent of human interaction during the measurement process. The system tracks instruments and displays their position and trajectory on images without direct human interpretation being part of the measurement for these accuracy metrics.
7. The Type of Ground Truth Used:
The ground truth used for this accuracy study was derived from precise physical measurements taken on "anatomically representative phantoms." This implies that the true position and trajectory were known and used as reference points against which the device's reports were compared.
8. The Sample Size for the Training Set:
The document does not provide information about a training set since the study described is a performance validation of a medical device's accuracy, not a machine learning model that would require a dedicated training set. The software likely undergoes extensive internal development and testing, but separate "training set" details are not provided in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set information is provided or relevant for this type of accuracy study.
§ 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).