(267 days)
The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the IGS workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-Ray, MR, MRA and ultrasound based model of the anatomy.
Example procedures include but are not limited to:
Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies Pediatric Catheter Shunt Placement General Catheter Shunt Placement Thalamotomies/ Palliodotomies
ENT Procedures: Transphenoidal procedures
Maximillary antrostomies Ethmoidectomies Spheno-idotomies/ sphenoid explorations Turbinate resections Frontal sinusotomies Intranasal
The Cranial IGS System consists of the IGS workstation, the touch screen monitor and the 3D tracking system. A set of hardware accessories provides for comfortable and accurate use of the system.
The IGS workstation holds the patient data during the surgery and runs the cranial software application.
The patient data needed for the image-guided surgery is acquired pre-operatively or intraoperatively and is transferred to the IGS workstation via network, data carrier or data bus. The cranial software application offers the display of the patient data in various reconstructions, segmentations and overlays on the touch screen in addition to position information of tracked instruments – optionally combined with outlined information. The touch screen enables the control of the cranial software application and can be draped for sterile use by the surgeon.
The electro-magnetic or optical 3D tracking system performs the localization of patient and surgical tools within the operating field.
The virtual diagnostic image spaces are correlated ("registered") to the surgical environment by collecting the 3D position of anatomical landmarks or fiducial markers with a tracked pointer probe and relating them with the corresponding features extracted from the diagnostic image data sets. Alternatively, the patient's skin surface can be scanned with a laser device or touched with a pointer device and matched to the 3D reconstruction of the patient data set. If several diagnostic image spaces have been acquired from the same patient, only one of them has to be registered whereas the remaining ones can be fused to the registered data set.
Intra-operatively acquired patient data can furthermore be correlated ("registered") to the surgical environment by determining its spatial position to the patient during its acquisition.
Structures in the patient's body are localized using trackable pre-calibrated or intra-operatively calibrated surgical instruments. Examples of surgical instruments are the pointer tool, biopsy needles, catheter stylets or suction tubes.
Surgical microscopes, ultrasound devices and endoscopes are additional intra-operative image sources, which are connected with the Cranial IGS System via signal transmission cables. They can be calibrated and tracked similar as any other surgical instrument. Their images can be displayed on the touch screen or external monitors and combined with the available patient data in correct spatial relation. The settings of microscope and ultrasound devices offering a communication interface can be controlled from the Cranial IGS System. Navigation information can be displayed in the microscope's image injection module. Defined components of the Cranial IGS System are prepared for the use in magnet-resonance environments.
The Cranial IGS System contains hardware accessories and software features to improve the support and guidance of surgical instruments.
The Cranial IGS System contains a network based software interface that allows downloading medical data (such as image sets, objects, trajectories or points) and tracking data from the system as well as to upload and display an image stream to the system. This interface can be used to implement custom visualization of medical data (e.g. included modalities which are otherwise unknown to the cranial software application) as well as to control other devices. These view data is strictly under the responsibility of the user and clearly marked as such.
The provided text describes the Cranial Image Guided Surgery System, which includes the predicate devices VectorVision cranial, VectorVision ENT, Kolibri cranial, Kolibri ENT, Cranial Essential, Cranial Unlimited, ENT Essential, and ENT Unlimited. The modification discussed is the addition of a "Disposable Stylet." The document focuses on establishing substantial equivalence for this new accessory rather than presenting a detailed study with specific acceptance criteria and performance data for the entire system or the stylet.
Therefore, the information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available in the provided text. The text primarily outlines the device's intended use, description, and the regulatory determination of substantial equivalence for the "Disposable Stylet" accessory.
However, based on the information provided, we can infer some aspects related to testing for the "Disposable Stylet" and general regulatory context.
1. A table of acceptance criteria and the reported device performance:
Specific numerical acceptance criteria and reported device performance metrics are not detailed in the provided document. The submission focuses on demonstrating substantial equivalence, which implies that the device (specifically the Disposable Stylet) performs at least as well as the predicate device in its intended function.
The text mentions:
- "The added accessory 'Disposable Stylet' has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."
- "Compatibility of the Disposable Stylet to third-party catheters has been shown in performance testing. Therefore the force necessary to extract the Disposable Stylet vs. third-party stylets out of catheters representing common boundary conditions like materials, coatings and sizes was measured. This had been done in air as well as in saline to simulate the intended use."
This indicates that performance testing was conducted, but the specific acceptance criteria (e.g., maximum extraction force, accuracy of calibration) and the quantitative results are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text refers generally to "performance testing" and "studies" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The testing described for the "Disposable Stylet" appears to be more focused on physical performance (e.g., extraction force) rather than expert interpretation of images or clinical outcomes that would require a ground truth established by medical experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. 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:
This information is not provided in the document. The device in question is an image-guided surgery system and a disposable stylet, which are tools for surgical navigation and instrument placement, not diagnostic AI systems for image interpretation that would typically involve MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an "intra-operative image guided localization system" that tracks a freehand probe relative to patient image data. It also includes the "Disposable Stylet" as a pre-calibrated guiding stylet. The nature of these devices inherently involves human interaction (the surgeon using the system and stylet). While the calibration of the stylet is "pre-calibrated" (meaning the software contains information optimized for it and user calibration is not necessary), the system itself is designed as a human-in-the-loop tool. Therefore, a purely standalone algorithm performance study, in the sense of a diagnostic AI, is unlikely to be relevant or described for this type of device. The verification and validation mentioned would likely involve testing the accuracy and reliability of the tracking system and the stylet's calibration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the Cranial IGS System generally, the "ground truth" for navigation is derived from the patient's own diagnostic image data (CT, CTA, X-Ray, MR, MRA, ultrasound) which are then registered to the patient's anatomy during surgery. This is a form of image-based anatomical ground truth.
For the Disposable Stylet, the "ground truth" for the performance testing cited (extraction force) would be the physical properties and measurements of the stylet and the catheters. The "calibration information optimized for the Disposable Stylet" stored in the software serves as its internal "ground truth" for tracking.
8. The sample size for the training set:
This information is not provided in the document. The device does not appear to be an AI/ML system that undergoes a "training" phase with a distinct training set in the typical sense. The software contains "calibration information optimized for the Disposable Stylet," which implies pre-determined parameters rather than a learned model from a large dataset.
9. How the ground truth for the training set was established:
This information is not provided in the document, as a "training set" and associated ground truth establishment (in the AI/ML sense) are not explicitly mentioned or implied for this type of device. The pre-calibration of the stylet would have been established through engineering and metrology processes to define its geometric properties to a high degree of accuracy.
§ 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).