Cranial Navigation: The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image data being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT. CTA. X-Ray, MR, MRA and ultrasound) of the anatomy, including: Cranial Resection (Resection of tumors and other lesions, Resection of skull-base tumor or other lesions, AVM Resection), Craniofacial Procedures (including cranial and midfacial bones) (Tumor Resection, Bone Tumor Defect Reconstruction, Bone Trauma Defect Reconstruction, Bone Congenital Defect Reconstructions, Orbital cavity reconstruction procedures), Removal of foreign objects.

Cranial EM System: Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as: Cranial Resection (Resection of tumors and other lesions, Resection of skull-base tumor or other lesions), Intracranial catheter placement.

Device Description

The subject device consists of several devices: Cranial Navigation using optical tracking technology, its accessory Automatic Registration iMRI, and Cranial EM System using electromaqnetic tracking technology.

Cranial Navigation is an image guided surgery system for navigated treatments in the field of cranial surgery, including the newly added Craniofacial indication. It offers different patient image registration methods and instrument calibration to allow surgical navigation by using optical tracking technology. The device provides different workflows guiding the user through preoperative and intraoperative steps. The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes. There are three different product lines of the IGS platforms: "Curve", "Kick" and Buzz Navigation (Ceiling-Mounted). Cranial Navigation consists of: Several software modules for registration, instrument handling, navigation and infrastructure tasks (main software: Cranial Navigation 4.1 including several components), IGS platforms (Curve Navigation 17700, Kick 2 Navigation Station, Buzz Navigation (Ceiling-Mounted) and predecessor models), Surgical instruments for navigation, patient referencing and registration.

Automatic Registration iMRI is an accessory to Cranial Navigation enabling automatic image registration for intraoperatively acquired MR imaging, The registration object can be used in subsequent applications (e.g. Cranial Navigation 4.1). It consists of the software Automatic Registration iMRI 1.0, a registration matrix and a reference adapter.

Similarly, the Cranial EM System, is an image-guided planning and navigation system to enable neurosurgical procedures. It offers instrument handling as well as patient registration to allow surqical navigation by using electromagnetic tracking technology. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "imaqe space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. It uses the same software infrastructure components as the Cranial Navigation, and the software is also installed on IGS platforms consisting of a mobile monitor cart and an EM tracking unit. It consists of: Different software modules for instrument set up, registration and navigation (Main software: Cranial EM 1.1 including several components), EM IGS platforms (Curve Navigation 17700 and Kick 2 Navigation Station EM), Surgical instruments for navigation, patient referencing and registration.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Brainlab AG's Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, and Automatic Registration iMRI. The document focuses on demonstrating substantial equivalence to predicate devices, particularly highlighting the introduction of Artificial Intelligence/Machine Learning (AI/ML) algorithms for specific features.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions acceptance criteria relating to system accuracy.

Acceptance Criteria	Reported Device Performance
Mean Positional Error ≤ 2 mm	Fulfilled (details not explicitly quantified beyond "fulfilled")
Mean Angular Error of instrument's axis ≤ 2°	Fulfilled (details not explicitly quantified beyond "fulfilled")
AI/ML performance for abnormity detection	Precision and recall higher than atlas-based method.
AI/ML performance for landmark detection	No concerns regarding safety and effectiveness (implicitly met expectations).
Software level of concern	"Major" level of concern addressed by V&V testing.
Usability	Summative usability carried out according to IEC 62366-1.
Electrical safety & EMC	Compliance to IEC 60601-1, AIM 7351731, IEC 60601-1-2.
Instruments	Biocompatibility, cleaning/disinfection, mechanical properties, aging, MRI testing (where applicable) – all evaluated.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set used for evaluating the AI/ML algorithm or other performance metrics. It only mentions the "test pool data is set aside at the beginning of the project."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just refers to "training pool data" and "test pool data."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. It mentions the AI/ML algorithm was developed using a Supervised Learning approach and that its performance was evaluated against a test pool, but no details on human ground truth labeling are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication methods used for the test set ground truth.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The AI/ML functionality described is for "pre-registration" and "centering of views," which are aids to the navigation system, but there is no indication of a study measuring human reader performance with and without AI assistance. The performance testing for AI/ML focuses on its own accuracy (precision and recall) compared to a previous atlas-based method, not human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone (algorithm only) performance evaluation was done for the AI/ML features. The text states: "For the two features now implemented using AI/ML (landmark detection in the pre-registration step and centering of views if no instrument is tracked to the detected abnormity), performance testing comparing conventional to machine learning based landmark detection and abnormity detection were performed showing equivalent performance as in the predicate device." It also highlights that for abnormity detection, "both precision and recall of the ML-based method are higher in comparison to the atlas-based method." This indicates an isolated evaluation of the algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the AI/ML algorithm. It mentions "Supervised Learning" and "training pool data," implying that the training data had pre-established labels (ground truth), but it doesn't specify if these labels came from expert consensus, pathology, or another source. Given the context of image-guided surgery, it's highly probable the ground truth for abnormalities and landmarks would be derived from expert annotations on medical images.

8. The sample size for the training set

The document does not explicitly state the numerical sample size for the training set. It only refers to a "training pool data."

9. How the ground truth for the training set was established

The document mentions that the AI/ML algorithm was developed using a "Supervised Learning approach." This means that the training data was pre-labeled. However, it does not specify how this ground truth was established (e.g., by manual annotation from a certain number of experts, based on surgical findings, etc.). It only states that the "training process begins with the model observing, learning, and optimizing its parameters based on the training pool data."

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 21, 2023

Brainlab AG Esther Moreno Garcia OM Consultant Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 Germany

Re: K223288

Trade/Device Name: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 20, 2023 Received: June 20, 2023

Dear Esther Moreno Garcia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, the text "Digitally Adam D. Date: 202 11:03:25" is present. The text on the right side of the image appears to be a digital signature. The text is black and the background is white.

Digitally signed by Adam D. Pierce -S Date: 2023.07.21 11:03:25 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223288

Device Name

Cranial Navigation Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Indications for Use (Describe) Cranial Navigation

The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image data being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT. CTA. X-Ray, MR, MRA and ultrasound) of the anatomy, including:

Cranial Resection
- · Resection of tumors and other lesions
- · Resection of skull-base tumor or other lesions
- · AVM Resection
· Craniofacial Procedures (including cranial and midfacial bones)
- · Tumor Resection
- Bone Tumor Defect Reconstruction
- · Bone Trauma Defect Reconstruction
- · Bone Congenital Defect Reconstructions
- · Orbital cavity reconstruction procedures
· Removal of foreign objects

Cranial EM System

Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as:

· Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
· Intracranial catheter placement

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

July 21, 2023

General Information
Manufacturer	Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany
Establishment Registration	8043933
Trade Name	• Cranial Navigation• Navigation Software Cranial• Navigation Software Craniofacial• Cranial EM System• Automatic Registration iMRI
Classification Name	Neurological Stereotaxic Instrument
Product Code	HAW
Regulation Number	882.4560
Regulatory Class	Class II
Panel	Neurology
Predicate Device(s)	Primary Predicate: K192703 Cranial Image Guided Surgery SystemSecondary Predicates: K162929 Stryker Navigation SystemK213989 Cranial EM System
Contact Information
Primary Contact	Alternate Contact
Esther Moreno GarciaQM Consultant - Regulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com	Chiara CunicoPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033Email: chiara.cunico@brainlab.com

1. Indication for Use

Cranial Navigation

The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform.

The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including:

Cranial Resection
- · Resection of tumors and other lesions
- Resection of skull-base tumor or other lesions

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AVM Resection
Craniofacial Procedures (including cranial and midfacial bones)
- · Tumor Resection
- Bone Tumor Defect Reconstruction
- Bone Trauma Defect Reconstruction
- · Bone Congenital Defect Reconstructions
- · Orbital cavity reconstruction procedures
- · Removal of foreign objects

Cranial EM System

Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures.

The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as:

· Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
· Intracranial catheter placement

2. Device Description

The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes. There are three different product lines of the IGS platforms: "Curve", "Kick" and Buzz Navigation (Ceiling-Mounted).

Cranial Navigation consists of:

. Several software modules for registration, instrument handling, navigation and infrastructure tasks (main software: Cranial Navigation 4.1 including several components)

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. IGS platforms (Curve Navigation 17700, Kick 2 Navigation Station, Buzz Navigation (Ceiling-Mounted) and predecessor models)
. Surgical instruments for navigation, patient referencing and registration

With this submission, several already existing features are now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML). This ML based functionality is used for the detection of inside-brain abnormities in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images to allow a more convenient centering of the views and as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points. This pre-reqistration step is not mandatory. The Al/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm. The training process begins with the model observing, learning, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against a test pool data is set aside at the beginning of the project. This is a static algorithm (locked).

It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "imaqe space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. It uses the same software infrastructure components as the Cranial Navigation, and the software is also installed on IGS platforms consisting of a mobile monitor cart and an EM tracking unit. It consists of:

Different software modules for instrument set up, registration and navigation (Main software: Cranial EM 1.1 including several components)
EM IGS platforms (Curve Navigation 17700 and Kick 2 Navigation Station EM) ●
Surgical instruments for navigation, patient referencing and registration ●

It uses the same artificial intelligence/machine learning algorithm as Cranial Navigation to support the registration step by allowing a pre-registration based on guide points/landmarks.

3. Substantial Equivalence

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Cranial Navigation:

Characteristic	Primary Predicate	Secondary Predicate	Subject device
	K192703	K162929
Indications foruse	The Cranial IGS System,when used with acompatible navigationplatform and compatibleinstrument accessories, isintended as an image-guided planning andnavigation system toenable navigated surgery.It links instruments to avirtual computer imagespace on patient imagedata that is beingprocessed bythenavigation platform.The system is indicated forany medical condition inwhich a reference to arigid anatomical structurecan be identifiedrelative to images (CT,CTA, X-Ray, MR, MRA andultrasound) of theanatomy, including:• Cranial Resection- Resection of tumors andother lesions- Resection of skull-basetumor or other lesions- AVM Resection• Cranial biopsies• Intracranial catheterplacement• Intranasal structures andParanasal Sinus Surgery- Functional endoscopicsinus surgery (FESS)- Revision & distortedanatomy surgery allintranasal structures andparanasal sinuses	The Stryker NavigationSystem, with theCranialMap softwareapplication, is intended asa planning andintraoperative guidancesystem to enable open orpercutaneous computerassisted surgery.The system is indicated forany medical condition inwhich the use ofcomputer-assistedplanning and surgery maybe appropriate. Thesystem can be used forintraoperative guidancewhere a reference to arigid anatomical structurecan be identified.The system should beoperated only by trainedpersonnel such assurgeons and clinic staff.The system assists in thepositioning of instrumentsfor cranial procedures,including:- Cranial biopsies- Puncture of abscesses- Craniotomies- Craniectomies- Resection of tumors andother lesions- Removal of foreignobjects- Skull base procedures- Transnasal neurosurgicalprocedures- Transphenoidal pituitarysurgery- Shunt placement,including pediatric shuntplacement	Compared to primarypredicate same cranialresection indications.Craniofacial indicationsare newly added and areequivalent to thesecondary predicate.

		- Placement of electrodesfor recording, stimulationand lesion generation- Endoscopic Sinus Surgery(ESS)- Intranasal procedures- Ear implant procedures- Craniofacial procedures- Skull reconstructionprocedures- Orbital cavityreconstructionprocedures
MechanismofAction	Infrared tracking camera isrecognizing infraredpassive markersInstrument tracking inrelation to the patientsanatomy.	Active wireless opticaltracking via infrared (IR)LED signal detection bythe camera. Instrumenttracking in relation to thepatients anatomy.	Same as primarypredicate, similar tosecondarydevice.
System accuracy	Mean navigation accuracyof ±2 mm and angular axisdisplacement of ±2°	Mean navigation accuracyof ±2 mm and angular axisdisplacement of ±2°	Same
Supportedimagingmodalities	CT, CTA, MR, MRA, US andPET	CT, CTA, MR, MRA, MRI,fMRI, DTI, PET and SPECT	Same as primary predicateand similar to secondarypredicate
Programminglanguage	C++ and C# (userinterface)	C and C++	Similar to both, subjectdevice uses HTML5 for GUI
OperatingSystem	Microsoft Windows 7,Microsoft Windows 8.1	Windows XP Embedded(SPC 3.0)Windows 8.1 (SPC3.1)Off the shelf (OTS) ServicePack 3	Similar. Win 8.1 andWin10 are used to havelatest technology.
Align views toview centroidwith abnormitydetection	Detection of abnormitiesbased on an atlas of thehuman anatomy to allow amore convenientcentering of views.	N/A	Compared to the primarypredicate device, overallfunctionality is the same,but the abnormity isdetected by an AI/MLbased method. If not allrequirements are met theprevious detection basedon an atlas of the humananatomy is used, as afallback.Testing demonstratedthat, both precision andrecall of the ML-basedmethod are higher incomparison to the atlas-based method. Thus, thechange in functionalitydoes not yield any newconcerns regarding safety
			and effectiveness of thedevice.
Detection ofanatomicallandmarks/guidepoints	Detection of anatomicallandmarks based on anatlas of the humananatomy.	N/A	Compared to the primarypredicate device, overallfunctionality is the same,but landmarks (used forcalculation of a pre-registration) are deliveredby a AI/ML based method.Testing demonstratedthere are no concernsregarding safety andeffectiveness.
IGS Platforms	Curve, Kick and BuzzNavigation models areused, consisting ofcomputer, touch monitorand IR camera.	The Stryker platformconsists of a computer, amonitor, an IR camera,and IO -Tablet(input/output).	Similar to predicates.Modified and newplatform models but withoverall same design andoperating principle.
Instruments	Instrumentation forpatient referencing,registration andnavigation.Compatible instrumentsfrom KLS Martin.	N/A	Same instrumentation.Former KLS MartinInstruments are nowlegally manufactured byBrainlab.

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Accessory Automatic Registration iMRI:

Characteristic	Primary Predicate K192703	Subject device
Supported imagemodalities	MR	Same
Supportedinstruments	Optical standard pointer, Softouch,calibrated instrument	Similar. Subject device restrictssupport to optical standard pointerand the Softouch Pointer
Workflow steps	Data selection, registration calculation,verify result and adjustments if needed.	Same steps with updated GUI.
Hardware	Matrix and adapter	Similar matrix and adapter. Differentdesign with same characteristics.
Structure	Functionality as a feature within theCranial 3.1 application	Separate application as an accessoryto the navigation.

Cranial EM System:

Characteristic	Third Predicate K213989	Subject device
Indications for use	Cranial EM is intended as an image-guided planning and navigation systemto enable neurosurgery procedures.	Same

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	The device is indicated for any medicalcondition in which a reference to a rigidanatomical structure can be identifiedrelative to images (CT, CTA, X-Ray, MR,MRA and ultrasound) of the anatomy,such as:•Cranial Resection-Resection of tumors and other lesions-Resection of skull-base tumor orother lesions•Intracranial catheter placement
Trackingtechnology	Electromagnetic tracking	Same
System accuracy	Mean navigation accuracy of ±2 mm andangular axis displacement of ±2°	Same
Functionality	Functionality for device set up,registration and navigation.	Same
Programminglanguage	C++	Same
Detection ofanatomicallandmarks/guidepoints(in surfacematchingregistration)	Detection of anatomical landmarksbased on an atlas of the humananatomy.	Compared to the predicate device,overall functionality is the same, butlandmarks (used for pre-registration)are delivered by an AI/ML basedmethod.Testing demonstrated there are noconcerns regarding safety andeffectiveness.
EM IGS Platforms	Curve Navigation 17700 and Kick 2Navigation Station EM	Same
Instruments	Instrumentation for patient referencing,registration and navigation.Compatible 3rd party instruments fromKLS Martin.	Same instrumentation.Former KLS Martin Instruments are nowlegally manufactured by Brainlab.

4. Performance Data

The following testing was conducted on the Subject Device to establish substantial equivalence with the predicate devices:

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This included product specifications, risk analysis or incremental test strategies. The software for this device was considered as a "major" level of concern.

For the two features now implemented using AI/ML (landmark detection in the pre-registration step and centering of views if no instrument is tracked to the detected abnormity), performance testing

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comparing conventional to machine learning based landmark detection and abnormity detection were performed showing equivalent performance as in the predicate device.

Usability Evaluation

Summative usability was carried out according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" in a simulated clinical environment for the new Craniofacial indication.

System accuracy testing

The positional and angular navigation accuracy for cranial procedures of the Subject Device including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst case scenarios. The results show the following acceptance criteria are fulfilled:

. Mean Positional Error of the placed instrument's tip ≤ 2 mm
Mean Anqular Error of the placed instrument's axis ≤ 2º .

Electrical safety and electromagnetic compatibility (EMC)

Compliance to electrical safety, RFID and EMC was evaluated on the Subject device according to the standards: IEC 60601-1, AIM 7351731 and IEC 60601-1-2.

Instruments

Instruments verification included:

Biocompatibility assessment
. Cleaning and disinfection evaluation/reprocessing
Mechanical properties of instruments
. Aging performance
. MRI testing (where applicable)

No clinical testing was needed for the Subject Device.

5. Conclusion

The comparison of the Subject Device with the predicate devices shows that Cranial Navigation and its accessory Automatic Registration iMRI and Cranial EM System have similar functionality, intended use and technological characteristics as the predicate device(s). Based on the comparison to the predicates and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).