Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

K223864 · Brainlab AG · HAW · Sep 9, 2023 · Neurology

Device Facts

• Record ID: K223864
• Device Name: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Sep 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures. The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEEG) electrodes.

Device Story

Image-guided surgery system supporting cranial stereotactic procedures; utilizes optical tracking to monitor instrument position relative to patient anatomy on pre/intraoperative images. System comprises IGS platform (computer, touch display, infrared camera), Alignment Software Cranial, and positioning devices (Cirq Arm System or VarioGuide). Surgeon uses system to plan and achieve trajectories for biopsy or sEEG electrode placement. Software includes AI/ML-based landmark detection to assist in registration. Hardware includes instrument holders, tracking arrays, guide tubes, bone anchors, drill bits, and depth stops. Used in clinical settings by surgeons. Output provides real-time visual feedback of instrument position on images, facilitating precise alignment to planned trajectories. Benefits include improved accuracy and guidance during neurosurgical interventions.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing, including software verification and validation, system accuracy testing (positional/angular error), usability evaluation in a simulated clinical environment, electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2, AIM 7351731), and instrument verification (biocompatibility, cleaning/disinfection, mechanical life cycle, and stability).

Technological Characteristics

System uses optical tracking with infrared cameras. Patient-contacting materials are stainless steel alloys. Platforms include Curve, Kick 2, and Buzz Navigation stations. Software includes a locked CNN-based AI/ML algorithm for landmark detection. Connectivity via IGS platform. Sterilization not applicable (instruments delivered non-sterile). Accuracy: ≤2mm positional, ≤2° angular error.

Indications for Use

Indicated for patients undergoing biopsy of intracranial lesions or placement of stereoelectroencephalography (SEEG) electrodes requiring cranial stereotactic procedures.

Regulatory Classification

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.

Predicate Devices

• Stealth Autoguide System (K191597)
• Cirq Robotic Alignment System (K210989)
• Cranial Image Guided Surgery System (K192703)

Submission Summary (Full Text)

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September 9, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K223864

Trade/Device Name: Alignment System Cranial. Alignment Software Cranial. Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 10, 2023 Received: August 10, 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" in large, bold font on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" followed by the date "2023.09.09" and the time "09:08:17-04'00'". The text on the right side of the image is smaller than the text on the left side of the image. The image appears to be a digital signature.

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) K223864

Device Name

Alignment System Cranial; Alignment Software Cranial;

Cirq Alignment Software Cranial Biopsy; Cirg Alignment Software Cranial sEEG;

Varioguide Alignment Software Cranial

Indications for Use (Describe)

Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.

The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEGG) electrodes.

| 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)

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Image /page/3/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain or neural network. To the right of the symbol is the word "BRAINLAB" in bold, pink capital letters. The overall design is clean and modern.

## 510(k) Summary

August 10, 2023

| General Information | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | Alignment System Cranial<br>Alignment Software Cranial<br>Cirq Alignment Software Cranial Biopsy<br>Cirq Alignment Software Cranial sEEG<br>Varioguide Alignment Software Cranial |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | Class II |
| Panel | Neurology |
| Predicate Device(s) | Primary Predicate: K191597 Stealth Autoguide System<br>Secondary Predicate: K210989 Cirq Robotic Alignment System<br>Third Predicate: K192703 Cranial Image Guided Surgery System |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Esther Moreno Garcia | Chiara Cunico |
| QM Consultant - Regulatory Affairs | Phone: [phone] |
| Phone: [phone] | Fax: [phone] |
| Email: [e-mail] | Email: [e-mail] |

#### 1. Indication for Use

Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.

The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEEG) electrodes.

#### Device Description 2.

The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.

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Image /page/4/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a medical symbol or a stylized brain. To the right of the symbol is the word "BRAINLAB" in large, pink, sans-serif letters. The logo is simple and modern, with a focus on the company name.

For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with its sw components is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the subject device tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the Alignment Software Cranial to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.

The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial 2.0 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device Varioquide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further robotic or manual alignment respectively to a defined trajectory.

In addition, the subject device offers a set of indication specific instruments to support biopsy and sEEG procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.

With this submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine (AI/ML). This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points which are delivered by this algorithm. This pre-registration step is not mandatory. The AI/ML algorithm is a Convolutional 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 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 the test pool. The test pool data is set aside at the beginning of the project. This is a static algorithm (locked).

The Alignment Software Cranial has the following accessories:

- . Automatic Registration providing an automatic registration for subsequent use.
- . Automatic Registration iMRI providing an automatic image registration for intraoperatively acquired MR images.

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Image /page/5/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.

### 3. Substantial Equivalence

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Characteristic | Primary Predicate<br>K191597 | Secondary Predicate<br>K210989 | Third Predicate<br>K192703 | Subject device |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The Stealth Autoguide System<br>is a positioning and guidance<br>system intended for the<br>spatial positioning and<br>orientation of instrument<br>holders or tool guides to be<br>used by neurosurgeons to<br>guide standard neurosurgical<br>instruments, based on a pre-<br>operative plan and feedback<br>from an image-guided<br>navigation system with three-<br>dimensional imaging<br>software.<br>The Stealth Autoguide System<br>is a remotely-operated<br>positioning and guidance<br>system, indicated for any<br>neurological condition in<br>which the use of stereotactic<br>surgery may be appropriate<br>(for example, stereotactic<br>biopsy, stereotactic EEG, laser<br>tissue ablation, etc.). | The Cirq Robotic Alignment<br>Module is an intraoperative<br>robotic positioning system<br>and an accessory to<br>compatible Brainlab IGS<br>Cranial software applications.<br>Using spatial information<br>from an image guided<br>navigation system, the Cirq<br>Robotic Alignment Module<br>enables the surgeon to align<br>and hold surgical instruments<br>according to pre-planned<br>trajectories.<br>The Cirq Robotic Alignment<br>Module is indicated for<br>stereotactic biopsies of<br>intracranial lesions | The Cranial IGS System, when<br>used with a compatible<br>navigation platform and<br>compatible instrument<br>accessories, is intended as an<br>image-guided planning and<br>navigation system to enable<br>navigated surgery. It links<br>instruments to a virtual<br>computer image space on<br>patient image data that is<br>being processed by the<br>navigation platform.<br>The system is indicated for<br>any medical condition in<br>which a reference to a rigid<br>anatomical structure can be<br>identified relative to images<br>(CT, CTA, X-Ray, MR, MRA and<br>ultrasound) of the anatomy,<br>including among others:<br>Cranial biopsies | Alignment System Cranial is<br>intended to support the<br>surgeon to plan and to<br>achieve a trajectory with<br>surgical instruments during<br>cranial stereotactic<br>procedures.<br>The medical indications for<br>use are biopsy of intracranial<br>lesions and placement of<br>stereo-<br>electroencephalography<br>(SEEG) electrodes. |
| Localization<br>technique | Optical markers on tool<br>holder | Infrared tracking camera is<br>recognizing infrared passive<br>markers | Infrared tracking camera is<br>recognizing infrared passive<br>markers | Same |
| | | Instrument tracking in<br>relation to the patients<br>anatomy. | Instrument tracking in<br>relation to the patients<br>anatomy. | |
| | | | | |
| | | | | |
| System accuracy | Under representative worst<br>case configuration: Mean<br>navigation accuracy of ±2 mm<br>and angular axis displacement<br>of ±2° | Under representative worst<br>case configuration: Mean<br>navigation accuracy of ±2 mm<br>and angular axis displacement<br>of ±2° | Under representative worst<br>case configuration: Mean<br>navigation accuracy of ±2 mm<br>and angular axis displacement<br>of ±2° | Same |
| Operating<br>principle | Preoperative images<br>(StealthStation)<br>Surgical planning<br>(StealthStation)<br>Patient registration<br>Guidance of instruments<br>Trajectory alignment | Preoperative images<br>Surgical planning<br>Patient registration<br>Guidance of instruments<br>Trajectory alignment with<br>Cirq Arm System plus Cirq<br>Robotic Alignment Module | Preoperative images<br>Surgical planning<br>Patient registration<br>Guidance of instruments<br>Trajectory alignment with<br>VarioGuide | Same<br>Subject device supports<br>alignment with both<br>VarioGuide or with Cirq Arm<br>System plus Cirq Robotic<br>Alignment Module |
| Planning<br>software | Compatible with:<br>S8 Cranial v1.1<br>Synergy Cranial v.3.1 | Compatible with:<br>Cranial 3.1<br>Trajectory 2.5 | Compatible with:<br>Cranial 3.1<br>Trajectory 2.5 | Same<br>In addition, Intra-op<br>trajectory planning feature<br>added to Alignment Software<br>Cranial |
| Alignment<br>Instrumentation | Navigated Trajectory Guide<br><br>Tool Holders (Drill Guides,<br>Reducing Tubes)<br><br>Height Guides<br><br>Tapping Tube | Cirq Arm System:<br>Instrument Holder Cranial +<br>Tracking Array Cranial<br>(Navigation and holding)<br><br>Cranial Drill Bit + Depth Stop<br>(Safe drilling)<br><br>Biopsy minimally invasive:<br>Guide Tube + Bone Anchor<br>(Holding and guiding of drill) | VarioGuide:<br><br>Biopsy with burr hole:<br>Compatible disc set (Biopsy<br>needle guidance) | Similar<br><br>Alignment instrumentation is<br>generally used in all devices<br>with a combination of<br>holders, guides and tubes.<br>Instrumentation has been<br>extended to support new<br>sEEG indication. |
| Instrument<br>fixation | Special tool holders for<br>different applications<br>mounted to the Stealth<br>AutoGuide | Cirq Robotic Disposable<br>Kinematic Unit to which<br>instrument holder is attached | Disc sets are mechanically<br>connected to the VarioGuide<br>assembly depending on<br>guiding diameter | Mechanical connection is<br>used in all devices for<br>instrument fixation. Identical<br>to predicate 2 and 3. |

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Image /page/6/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left and the word "BRAINLAB" in pink capital letters on the right. The symbol appears to be a stylized representation of the brain.

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Image /page/7/Picture/1 description: The image features the Brainlab logo, which is rendered in a vibrant pink color. To the left of the word "BRAINLAB" is a stylized graphic, also in pink, that appears to be a representation of the brain. The text "BRAINLAB" is written in a bold, sans-serif font, making it easily readable and prominent within the logo.

| Alignment<br>process | Fine alignment robotically<br>performed by Autoguide | Rough alignment:<br>Manual positioning of Cirq<br>Arm System with Autopilot<br>feature (Alignment Software)<br>close to final position<br>Fine alignment:<br>Robotic movement of Cirq<br>Robotic Alignment Module | Rough and fine alignment by<br>manual positioning of<br>VarioGuide along planned<br>trajectory with Autopilot<br>feature (Cranial Navigation) | Similar alignment process as<br>Predicate 1 and identical to<br>Predicates 2 and 3. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Registration | Optical Registration Device<br>(via StealthStation) | Optical registration from<br>Cranial 3.1<br>Methods: Surface matching,<br>landmark registration<br>Surface matching: No pre-<br>registration available. | Optical registration<br>(Registration 3.5)<br>Methods: Surface matching,<br>landmark registration.<br>Surface matching: Detection<br>of anatomical landmarks in<br>pre-registration based on an<br>atlas of the human anatomy. | Optical registration<br>(Registration 3.6). Same<br>registration methods as in<br>Brainlab predicates.<br>Compared to Predicate 3,<br>overall functionality is the<br>same, but landmarks (used<br>for pre-registration) are<br>delivered by an Al/ML based<br>method.<br>Testing demonstrated there<br>are no concerns regarding<br>safety and effectiveness. |
| IGS Platforms | StealthStation surgical<br>navigation platform<br>consisting of computer, touch<br>monitor and stereotactic<br>camera. | Curve, Kick and Buzz<br>Navigation models are used,<br>consisting of computer, touch<br>monitor and IR camera. | Curve, Kick and Buzz<br>Navigation models are used,<br>consisting of computer, touch<br>monitor and IR camera. | Similar to predicates.<br>Modified platforms (Kick 2<br>Navigation Station and Buzz<br>Navigation) and new platform<br>model (Curve Navigation<br>17700) but with overall same<br>components and operating<br>principle. |

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Image /page/8/Picture/0 description: The image shows the Brainlab company logo. The logo consists of a stylized caduceus symbol on the left, followed by the word "BRAINLAB" in all capital letters. The color of the logo is a bright pink.

#### 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 landmark detection feature in the pre-registration step now implemented using AI/ML, performance testing comparing conventional to machine learning based landmark detection was performed showing equivalent performance as in the third 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 to validate the new use scenarios: Varioguide for biopsy and Cirq for sEEG workflows. This covered aspects such as the guidance provided by the updated Alignment Software Cranial, the handling of instruments or the assembly of the positioning devices with overall focus on new or changed features. The final designs were proven safe and effective for use in the defined use scenarios.

#### System accuracy testing

The positional and angular navigation accuracy for biopsy and sEG procedures of the Subject Device including the software, the platforms, the positioning devices 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 Angular Error of the placed instrument's axis ≤ 2°

Therefore, the Subject Device achieves the same accuracy performance as the three predicate devices considered.

#### 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. The tests have shown that the subject device performs as intended.

#### Instruments

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Image /page/9/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain with interconnected pathways. To the right of the symbol, the word "BRAINLAB" is written in bold, pink capital letters.

Instruments verification included:

- . Biocompatibility assessment considering the materials used in the devices, manufacturing, processing, biological and chemical test data, and the history of safety and effectiveness of the device materials in contact with the human body.
- Cleaning and disinfection evaluation/reprocessing validation.
- . Mechanical properties of instruments by performing life cycle simulations and verification of clearance fits, material fatigue, functionality, etc.
- . Stability performance testing was performed in selected worst case situations for the drill bits to ensure they can withstand the loads they might be exposed to during use.

No clinical testing was needed for the Subject Device since optical tracking technology in the scope of image guided surgery for the included indications for use is well established in the market.

#### 5. Conclusion

The comparison of the Subject Device with the predicate devices shows that the Alignment System Cranial has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicates and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate devices.