(47 days)
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive localization system to a virtual computer image space on a patient 3D preoperative diagnostic image data set being processed by the Kolibri computer 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 vertebrae is identified relative to a CT, X-ray or MR based model of the anatomy.
Example image guided cranial surgery procedures include but are not limited to:
- Tumor resections
- Skull base surgery
- Cranial biopsies
- Craniotomies/Craniectomies
- Pediatric Catheter Shunt Placement (New)
- General Catheter Shunt Placement (New)
Example image guided ENT surgery procedures include, but are not limited to:
- Transphenoidal procedures
- Maxillary antrostomies
- Ethmoidectomies,
- Sphenoidotomies./sphenoid explorations,
- Turbinate resections
- Frontal sinusotomies
- Intranasal procedures
The Kolibri Image Guidance System is based on a portable hardware platform with integrated touch screen monitor, 3D controller and computer workstation. The localization of patient and surgical instruments in the operating field will be performed by a magnetic or optical 3D localization system. All patient data needed for the image guided surgery procedure will be transferred via the hospital LAN network or external media (e.g. a cd-ROM) to the Kolibri workstation. Once the data is loaded, the application software automatically starts with the patient registration procedure. The user may perform the patient to 3D data registration either by using anatomical landmarks, fiducial markers, or a tracked registration pointer. The surgeon can control all software functions of the navigation system via touch screen. Therefore the monitor of the Kolibri navigation system will be draped with a sterile drape during the procedure.
The provided 510(k) summary for the Kolibri™ Image Guided Surgery System (K042391) does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against these criteria. The submission mainly focuses on demonstrating substantial equivalence to predicate devices (K014256 and K022126) for existing functionalities and new indications.
Therefore, many of the requested details, such as specific performance metrics, sample sizes for test sets, expert qualifications, ground truth establishment methods, and MRMC study results, are not present in the provided document.
However, based on the available information, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. The document does not detail specific quantitative performance metrics (e.g., accuracy, precision, latency) or associated acceptance thresholds. The primary "performance" discussed is the technical equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document mentions that the application software automatically starts with the patient registration procedure, suggesting that testing would involve patient data, but does not specify the size or nature of any test set used in a formal study for this submission. There is no mention of country of origin or whether data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The document does not describe a study involving expert-established ground truth for performance evaluation related to the new indications or modifications.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. The device is described as an image-guided surgery system, not an AI-assisted diagnostic tool that would typically involve human reader improvement studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The 510(k) summary does not describe a standalone performance study. The device is referred to as an "Image Guided Surgery System," implying human interaction and control are inherent to its use. The mention of "patient to 3D data registration either by using anatomical landmarks or by a patient tracker with a fiducial marked registration pointer" directly involves human interaction in setting up the system for the procedure.
7. The Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used for any formal performance validation in the context of this submission. The system correlates surgical instruments to "patient's CT, MR or fluoroscopic images of the reference geometry," implying that the ground truth for instrument position would ideally be the actual physical placement validated against imaging. However, details of how this was formally assessed for the purpose of this 510(k) are absent.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document does not discuss a "training set" in the context of machine learning. The device is based on established image guidance technology, not a deep learning model requiring a large training dataset as often seen in AI/ML submissions.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary, as there is no mention of a training set or machine learning components that would require such established ground truth. The system's functionality is described in terms of localization systems, data transfer, and patient registration procedures.
Summary of What is Available:
The K042391 submission is a 510(k) summary for extending the functionality of the Kolibri™ Image Guided Surgery System to include instruments for catheter placement, specifically targeting Pediatric Catheter Shunt Placement and General Catheter Shunt Placement. The basis for clearance is substantial equivalence to existing predicate devices (Kolibri™ Image Guided Surgery System K014256 and Catheter Introducer for the StealthStation System K022126). The applicant states that the "received option of the Kolibri system is technically equivalent" and provides "new indications that are substantially equivalent to the named predicate devices' indication for use." This type of submission relies on demonstrating that the new features or indications do not raise new questions of safety and effectiveness, leveraging the established safety and effectiveness of predicate devices, rather than presenting a de novo performance study with explicit acceptance criteria.
§ 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).