Geniant Cranial (Navigated Neurosurgical Positioning Robot)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 10, 2026 Koh Young Technology, Inc. Sooji Shin RA Team Leader 1f, 66-27, Gwangdae 2-Gil, Sejongdaewang-Myeon, Yeoju-Si Yeoju, Gyeonggi-do 12647 Republic Of Korea Re: K253856 Trade/Device Name: Geniant Cranial (Navigated Neurosurgical Positioning Robot) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 12, 2026 Received: June 12, 2026 Dear Sooji Shin: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253856 - Sooji Shin Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K253856 - Sooji Shin Page 3 Sincerely, JULIA E. SLOCOMB -S Digitally signed by JULIA E. SLOCOMB -S Date: 2026.09.10 15:40:22 -04'00' for Jaime Raben, Ph.D. 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 {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K253856 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Geniant Cranial (Navigated Neurosurgical Positioning Robot) (SW V3.2) | | | | | Please provide your Indications for Use below. | | | ? | | The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images. | | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? | | {4} K253856 Page 1 of 8 # 510(k) Summary ## Geniant Cranial (SW V3.2) 1. Submission Applicant a. Company: KOH YOUNG TECHNOLOGY Inc. 1F, 66-27, Gwangdae 2-gil, Sejongdaewang-myeon, Yeoju-si, Gyeonggi-do, Republic of Korea b. Contact: Sooji Shin RA Team Leader Office Phone: +82-31-5181-8590 Email: sj.shin@kohyoung.com 2. Date Prepared 06/11/2026 3. Device Identification Trade/Proprietary Name: Geniant Cranial (Navigated Neurosurgical Positioning Robot) Classification Name: Neurological stereotaxic instrument Regulation Number(s): 882.4560 Product Code(s): HAW Secondary Classification: Classification Name: Holder, head, neurosurgical (skull clamp) Regulation Number: 882.4460 Product Code: HBL Class: II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) Device name: Geniant Cranial (Navigated Neurosurgical Positioning Robot) 510(k) number: K241333 Manufacturer: KOH YOUNG TECHNOLOGY Inc. 5. Device Description Geniant Cranial is a hardware platform that supports real-time surgical navigation using medical patient images. The application software reprocesses the CT or MR images of the patient acquired before surgery. {5} K253856 Page 2 of 8 It displays the contents on the software screen in various fluoroscopy directions (axial, sagittal and coronal). Before surgery, the surgeon can create and save one or more surgical routes to simulate. The surgeon may create and manipulate one or more 3D models of human anatomy before the surgery. During surgery, the system tracks the position of special surgical tools in the patient's anatomy and continuously updates the positions of the surgical tools in these images. The application software can also show you how the actual position and path during surgery relate to the pre-operative plan and guide the surgeon to follow the planned trajectory. The real-time location information obtained through Geniant Cranial can help guide the surgeon's decision and the surgical route. This 510(k) submission addresses a new software feature that enables robot movement with the Robot Tool Guide or Drive (RTG or RTD) attached, providing improved workflow efficiency for the user. All other system functions, intended use, and established safety features remain unchanged. ### 6. Indication for Use Statement The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images. ### 7. Substantial Equivalence Discussion The following table compares the Geniant Cranial (SW V3.2) to the predicate device with respect to indications for use, principle of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. #### Special Note on SW V3.2: The subject device, Geniant Cranial (SW V3.2), introduces a new optional software feature allowing robot movement while the Robot Tool Guide (RTG) or Robot Tool Drive (RTD) is attached. This new functionality—developed in direct response to user requests for improved workflow efficiency—was found to introduce a newly identified risk of increased potential for patient collision and tissue injury. These risks were thoroughly analyzed and mitigated by the implementation of new software control measures and detailed user instructions. Due to this risk identification, a new 510(k) is being submitted for SW V3.2 in accordance with FDA guidance. Other updates made since the predicate device relate to usability improvements, reliability, and defect correction and were not found to have a significant impact on device safety or effectiveness. Table 1 - Comparison of Characteristics | Attributes | Subject Device | Predicate Device | Comparison | | --- | --- | --- | --- | | 510(k) Number | New device | K241333 | N/A | | Manufacturer | KOH YOUNG TECHNOLOGY INC. | KOH YOUNG TECHNOLOGY INC. | N/A | {6} K253856 Page 3 of 8 | Trade Name | Geniant Cranial | Geniant Cranial | N/A | | --- | --- | --- | --- | | Classification Name | Neurological stereotaxic instrument | Neurological stereotaxic instrument | Same | | Product code | HAW | HAW | Same | | Regulation Number | 882.4560 | 882.4560 | Same | | Intended Use / Indications for Use | The device is intended for use as an aid for locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery 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 device is intended for use as an aid for locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures. The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. | Same | | Anatomical site | Head | Head | Same | | Sites of use | Operating rooms | Operating rooms | Same | | Operator | Neurosurgeon / Staff inside sterile field / Staff outside sterile field | Neurosurgeon / Staff inside sterile field / Staff outside sterile field | Same | | System Architecture | • Console with optical sensor (Navigation HW platform) • Robot stand with robotic arm and Patient Positioning Module • Application SW • Optical markers • Probes • Head frame (O-frame kit) • Various tools mounted on robot arm to hold the surgical tools and make a path according to planning • Various optional parts and accessories for ease of use | • Console with optical sensor (Navigation HW platform) • Robot stand with robotic arm and Patient Positioning Module • Application SW • Optical markers • Probes • Head frame (O-frame kit) • Various tools mounted on robot arm to hold the surgical tools and make a path according to planning • Various optional parts and accessories for ease of use | Same | | Principle of operation | • Intraoperative/preoperative images • Patient registration • Surgical Planning • Real-time tracking of navigated instruments • Guidance of instruments | • Intraoperative/preoperative images • Patient registration • Surgical Planning • Real-time tracking of navigated instruments • Guidance of instruments | Same | | Input images | • 3D preoperative exam • 3D intraoperative exam • 2D intraoperative exam | • 3D preoperative exam • 3D intraoperative exam • 2D intraoperative exam | Same | {7} K253856 Page 4 of 8 | Integrated Planning Software | • KGuide V3.2 | • KGuide V3.0 | Different | | --- | --- | --- | --- | | Localization means | Infrared camera (Navigation Camera, manufactured by Koh Young Technology) and Robot arm relative encoders | Infrared camera (Navigation Camera, manufactured by Koh Young Technology) and Robot arm relative encoders | Same | | Scanner Interface Technology (to imaging devices) | CD, DVD, USB DICOM Import/Export | CD, DVD, USB DICOM Import/Export | Same | | Preoperative images & surgical planning features | • DICOM compliance • Merge images (multimodality image fusion capability) • Save/load planning • Plan Entry and Target Selection • 3D Model Building (Segmentation) | • DICOM compliance • Merge images (multimodality image fusion capability) • Save/load planning • Plan Entry and Target Selection • 3D Model Building (Segmentation) | Same | | Patient registration method | • Point-to-point registration with anatomical markers or skin/bone fiducials • Stereotactic Localizer Registration • Optical trace merge • Optical surface registration | • Point-to-point registration with anatomical markers or skin/bone fiducials • Stereotactic Localizer Registration • Optical trace merge • Optical surface registration | Same | | Instruments guidance Features | • Image-guided • Real-time display of the instrument position • Provide guidance for surgical instruments • Automatic instrument guide position adjustment • Surgeon carries out the final gesture through the instrument guide with the traditional surgical instrument | • Image-guided • Real-time display of the instrument position • Provide guidance for surgical instruments • Automatic instrument guide position adjustment • Surgeon carries out the final gesture through the instrument guide with the traditional surgical instrument | Same | | Guidance (robot arm) controller | Axis controller for each joint Kinematic transformation between the Cartesian space and joint space Supervisor module | Axis controller for each joint Kinematic transformation between the Cartesian space and joint space Supervisor module | Same | | Vigilance system | • Foot pedal | • Foot pedal | Same | | Performance | • 3D positional accuracy with a mean error ≤ 1.5 mm • Trajectory angle accuracy with a mean error ≤ 2.0 degrees | • 3D positional accuracy with a mean error ≤ 1.5 mm • Trajectory angle accuracy with a mean error ≤ 2.0 degrees | Equivalent performance supported by SW V3.2 test data. | | Sterility | • Non-sterile instruments • Disposable sterile drapes and covers for the robot arm | • Non-sterile instruments • Disposable sterile drapes and covers for the robot arm | Same | | Body Contact | Probes (skin, bone, brain tissue) Fixation pins for head fixation to a head frame (skin, bone) | Probes (skin, bone, brain tissue) Fixation pins for head fixation to a head frame (skin, bone) | Same | {8} K253856 Page 5 of 8 | Applicable standards for safety | AAMI/ANSI ES 60601-1 IEC 60601-1-2 ISO 10993-1 IEC 62304 ISO 17665-1 | AAMI/ANSI ES 60601-1 IEC 60601-1-2 ISO 10993-1 IEC 62304 ISO 17665-1 | Same | | --- | --- | --- | --- | ### 8. Non-Clinical Performance Data To demonstrate safety and effectiveness of Geniant Cranial and to show substantial equivalence to the predicate device, Koh Young completed all applicable non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Geniant Cranial passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device: Table 2 -Applied standards and regulations | Standard / Regulation No. | Title | | --- | --- | | IEC 60601-1:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | IEC 60601-1-2:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements | | IEC 62471:2006 | Photobiological safety of lamps and lamp systems | | IEC 60601-1-6:2020 | Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 62366-1:2020 | Medical devices - Part 1: Application of usability engineering to medical devices | | ANSI/AAMI HE75:2009/(R)2018 | Human factors engineering – Design of medical devices | | ASTM F2554-18 | Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems | | ISO 9283:1998 | Manipulating industrial robots - Performance criteria and related test methods | | AAMI TIR57:2016 | Principles for Medical Device Security - Risk Management | | AAMI TIR97:2019 | Principles for medical device security - Postmarket risk management for device manufacturers | | UL 2900-1 First Edition 2017 | Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements | | UL 2900-2-1 First Edition 2017 | Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems | | IEC 62304:2015 | Medical device software - Software life cycle processes | | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | | ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | | ISO 10993-4:2017 | Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood | | ISO 10993-5:2009 | Biological evaluation of medical devices - Cytotoxicity | | ISO 10993-10:2021 | Biological evaluation of medical devices - Skin Sensitization | | SO 10993-11:2017 | Biological evaluation of medical devices - Systemic Toxicity | | SO 10993-23:2021 | Biological evaluation of medical devices - Irritation | | ASTM F2901-19 | Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices | | USP <151> | United States Pharmacopeia - Pyrogen | {9} K253856 Page 6 of 8 | ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices | | --- | --- | | ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. | | AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers | | AAMI TIR30:2011/(R)2016 | A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices | | ANSI/AAMI ST81: 2004/(R)2016 | Sterilization of medical devices - Information - Processing of Resterilizable Medical Devices | | ISO 11737-1:2018/AMD 1:2021 | Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | | ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | | ANSI AAMI ISO 14937:2009/(R)2013 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | | ISO 17665-1:2006 | Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | | ANSI/AAMI ST79:2017 with Amendments A1:2020, A2:2020, A3:2020, A4:2020 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities | | ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | | ISO 10993-7:2008_Amd1:2019 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] | | ISO 22441:2022 | Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | | ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | | ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes | | ASTM F88-15 | Standard Test Method for Seal Strength of Flexible Barrier Materials | | ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | | ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | | ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | | ANSI AAMI ST77:2013/(R)2018 | Containment devices for reusable medical device sterilization | | ASTM F1608-21 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) | | AATCC 42-2017 | Standard Test Method for Water Resistance: Impact Penetration | | AATCC 127-2017(2018)e | Standard Test Method for Water Resistance: Hydrostatic Pressure | | ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | | ISO 7000:2019 | Graphical symbols for use on equipment - Registered symbols | {10} K253856 Page 7 of 8 | ISO 7010: 2019 | Graphical symbols - Safety colours and safety signs - Registered safety signs | | --- | --- | | ISO 20417:2021 | Medical devices - Information to be supplied by the manufacturer | | IEC/TR 60878 Ed. 4.0 b:2022 | Graphical symbols for electrical equipment in medical practice | | IEC 60417:2002 DB | Graphical symbols for use on equipment | | ISTA 3E 2017 | Similar Packaged-Products in Unitized Loads of Truckload Shipment | | FDA Guidance | Electromagnetic Compatibility (EMC) of Medical Devices (06/06/2022_Final) | | FDA Guidance | Radio Frequency Wireless Technology in Medical Devices (08/14/2013_Final) | | FDA Guidance | Applying Human Factors and Usability Engineering to Medical Devices (Feb, 2016) (Final) | | FDA Guidance | Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | | FDA Guidance | Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (12/28/2016_Final) | | FDA Guidance | Content of Premarket Submissions for Device Software Functions (June 2023) | | FDA Guidance | Off-The-Shelf Software Use in Medical Devices | | FDA Guidance | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (09/08/2023_Final) | | FDA Guidance | Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (03/17/2015_Final) | | FDA Guidance | Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) | ### 9. Discussion of the Key Performance (Accuracy) Testing To simulate the clinical procedure as closely as possible, Koh Young considered all parameters that may influence the stereotactic procedure, which include the different devices, accessories, and components of Geniant Cranial, other influencing devices used in the procedure that are validated to be compatible with Geniant Cranial, and other elements of the surgical environment. Under the representative worst-case configuration considering an actual clinical procedure, the Geniant Cranial has demonstrated performance in 3D positional accuracy with a mean error ≤1.5 mm and trajectory angle accuracy with a mean error ≤2.0 degrees. Below are the test results. Table 3 – Accuracy Testing Result | Applied registration method | Positional Accuracy (mm) | | | Trajectory Angle Accuracy (degrees) | | | | --- | --- | --- | --- | --- | --- | --- | | | Mean | Standard Deviation | 99% CI* Upper Bound | Mean | Standard Deviation | 99% CI* Upper Bound | | Paired Point Registration (PPR) | 0.753 | 0.324 | 1.588 | 0.271 | 0.137 | 0.624 | | Bone Fiducial Registration | 0.806 | 0.383 | 1.793 | 0.297 | 0.155 | 0.697 | | Tracing Registration | 0.903 | 0.407 | 1.952 | 0.340 | 0.153 | 0.735 | *CI: Confidence Interval {11} K253856 Page 8 of 8 # 10. Statement of Substantial Equivalence Geniant Cranial (V3.2) has the same indications for use as the predicate device. The newly identified risk associated with the additional robot movement feature has been addressed through thorough safety analysis, risk control measures, and software validation. Other minor differences in technological characteristics have been successfully evaluated through appropriate safety and performance testing, and do not raise new questions of safety and effectiveness. Therefore, Geniant Cranial (SW V3.2) is determined to be substantially equivalent to the predicate device.