The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.

Device Description

The Sinobot X1 device is a computer-aided, robotized image-guided interactive surgical system. The system integrates medical image processing technology with robotic surgery technology to assist the surgeon during brain surgeries. The system allows the surgeon to utilize the spatial positioning technology to pre-plan the instruments on medical images and provide stable, precise and reproducible guidance in accordance with the planning. The device consists of a robotic stand with a compact robotic arm and a touch screen. The robotic arm can attach to different types of instruments and be changed based on the intended surgical procedures. For different surgical procedures a biopsy needle, stimulation or recording electrode could be attached to the device.

The 3D Optical scanner is an optical device combined by a projector and a visible light camera. Which provide a high-resolution point cloud scanning of patients' facial skin surface in order to perform patient registration.

AI/ML Overview

The provided text describes the Sinobot X1, a computer-aided, robotized image-guided interactive surgical system, and its substantial equivalence to a predicate device. Regarding acceptance criteria and the study proving it, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in the provided text. However, the accuracy testing results imply that the reported performance values are within an acceptable range for regulatory clearance (as the device received substantial equivalence). Given the context of a stereotaxic instrument for neurosurgery, high accuracy is paramount.

Device Performance	Acceptance Criteria (Implied)	Reported Device Performance (Mean)	Standard Deviation	Confidence Interval at 99% Confidence Level
Positional accuracy [mm]	Needs to be sufficiently precise for neurosurgery, likely less than or equal to a few millimeters for safe and effective use.	0.613 mm	0.197 mm	1.205 mm
Angular accuracy [degree]	Needs to be sufficiently precise for neurosurgery, likely less than or equal to a few degrees for safe and effective use.	0.439 degrees	0.241 degrees	1.163 degrees

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the accuracy tests (positional and angular accuracy). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these specific tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the accuracy tests. These tests are typically conducted using precision measurement tools and phantoms, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable for the reported non-clinical accuracy tests as they are objective measurements rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the Sinobot X1 based on the provided information. The study described focuses on non-clinical performance data (accuracy and safety testing) for device clearance, not on human-in-the-loop performance or comparative effectiveness against human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the accuracy tests (positional and angular) can be considered standalone performance assessments of the device's robotic and guidance capabilities. These tests evaluate the inherent precision of the system without direct human surgical intervention as part of the measurement.

7. The Type of Ground Truth Used

For the positional and angular accuracy tests, the ground truth would be established by highly precise metrology equipment or calibrated phantoms with known spatial and angular relationships. These are objective engineering measurements rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the reported accuracy tests. These are non-clinical hardware/software performance validations, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is mentioned in relation to the reported performance evaluation.

Summary

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June 18, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sinovation (Beijing) Medical Technology Co., Ltd % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K220072

Trade/Device Name: Sinobot X1 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 15, 2023 Received: May 18, 2023

Dear Giselle Zhang:

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,

Digitally signed Adam D . by Adam D. Pierce -5 Pierce -S Date: 2023.06.18 10:18:57 -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) K220072

Device Name Sinobot X1

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)	X Prescription Use (Part 21 CFR 801 Subpart D)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)	Over-The-Counter Use (21 CFR 801 Subpart C)
Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

5.1 Submitter Information

Company:	Sinovation (Beijing) Medical Technology Co.LtdRm 401, Bld 12-1, No.26 Yongwang WestRoad, Z- parkDaxing, Beijing, Beijing 102600 P.R.ChinaTelephone:Fax: N/A
Contact:	Manman XuRA Specialistxumanman@sinovationmed.comGiselle ZhangRegulatory ConsultantEmergo Global Consulting, LLC2500 Bee Cave Road, Building 1, Suite 300Austin, Texas 78746 USATelephone: (512) 327-9997Fax: (512)327-9998LST.AUS.ProjectManagement@ul.com
Date Summary Prepared:	June 18, 2023
5.2 Name of the Device
Trade/Device Name:	Sinobot X1
Common Name:	Stereotaxic Instrument
Classification Name:	Neurology
Review Panel:	Neurology (NE)
Regulation:	882.4560
Class:	Class II
Product Code:	HAW

5.3 Equivalence Claimed to Predicate Device

The Sinovation is equivalent to the ROSA ONE Brain application (K200511), manufactured by Medtech S.A.

5.4 Indications for Use Statement

The Sinobot X1 is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained neurosurgeons to guide standard neurosurgical instruments

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(biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic neurosurgery may be appropriate.

5.5 Device Description

5.6 Substantial Equivalence Discussion

The following table compares the Sinovation to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Attribute	Sinovation Sinobot X1	ROSA ONE 3.1.3.2Brain Application(K200511)	Comparison
Manufacturer	Sinovation (Beijing)Medical TechnologyCo., Ltd	Medtech S.A	N/A
Product Code	HAW	HAW	Same
RegulationNumber	882.4560	882.4560	Same
Indications for Use	The Sinobot X1 isintended for the spatialpositioning andorientation ofinstruments holders ortool guides to be used bytrained neurosurgeons to guide standardneurosurgicalinstruments (biopsyneedle, stimulation or	The device is intended forthe spatial positioningand orientation ofinstruments holders ortool guides to be usedby trainedneurosurgeons to guidestandard neurosurgicalinstruments (biopsyneedle, stimulation orrecording electrode,recording electrode). The device is	Same

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	device is indicated forany neurosurgicalprocedure in which theuse of stereotacticneurosurgerymay be appropriate.	indicated for anyneurosurgical procedurein which the use ofstereotactic neurosurgerymay be appropriate.
	Pre-Operative PlanningIntra-OperativeRegistrationIntra-OperativeGuidance	Pre & intraoperativeimagesSurgical planning PatientRegistration Guidance ofinstruments	Same
Mechanism ofAction			Only the description isdifferent.
Where Used	Neurosurgical operatingroom	Neurosurgical operatingroom	Same
User	Neurosurgeon	Neurosurgeon	Same
Anatomical Site	Head	Head	Same
Images Type	3D MRI / CT	3D MRI / CT	Same
DICOMCompliance	Yes	Yes	Same
IntegratedPlanning Software	Stereotactic PlanningSystem Software	ROSANNA BRAIN(Medtech)	DifferentAll software functionsand features are similar.
TrajectoryPlanningParameters	Parameters for planningtrajectories: entry point,target point, length of theinstrument, diameter,name	Parameters for planningtrajectories: entry point,target point, length of theinstrument, diameter,name, security radius(10mm by default),security aperture (10° bydefault)	Different
TrajectoryDefinition(EndoscopyModule)	No endoscopic module	Parameters for planningtrajectories: entry point,target point, length of theinstrument, diameter,name, security radius(10mm by default),security aperture (10° bydefault)	DifferentThe subject device doesnot contain endoscopicmodule, the difference ofthe two devices will notraise concerns related tothe safety andeffectiveness.
Save/LoadPlanning	Yes	Yes	Same
PatientRegistrationMethods	Fiducial markers(bone)Optical registrationdevice	Fiducial markers (skin,bone)Optical registrationdevice	Same

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		Stereotacticframe(fiducials mounted on theframe)
FiducialMarkersRegistrationwithPointer Probe	Yes	Yes	Same
Surface MatchingRegistration withOptical DistanceSensor	Yes	Yes	Same
			Different
Laser Class forOpticalRegistration	Class 2 laser Wavelength- 655nmMaximum Output –560μW(complies with 21 CFR1040.10)	Class 2 laser Wavelength- 658 nmMaximum output – 1 mW(complies with 21 CFR1040.10)	Even though thespecifications aredifferent, the subjectdevice passed thestandards requirementsand is safe to use, hencethe difference will notraise concerns in safetyand effectiveness.
Image-Guided	Yes	Yes	Same
Real Time Displayof the InstrumentPosition	Yes	Yes	Same
Provide Guidancefor SurgicalInstruments	Yes	Yes	Same
Instrument GuidePositionAdjustment	Automatic (robotized)	Automatic (robotized)	Same
InstrumentFixation	Instruments aremounted on robotic arm	Instruments aremounted on robotic arm	Same
			Different
Instruments	Instrument holder,holder and adaptors,optical sensor	Instrumentendoscopeholder andadaptors,optical sensor	The instruments of bothdevices are the sameexcept the endoscopicmodule, which thesubject device does nothave. The difference willnot affect the use of thedevice and will not affect

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			and raise new risksrelated to safety andeffectiveness of thedevice.
			device.
InstrumentCalibrationMethod	Factory calibration	Factory calibration	Same
AssociatedEquipment	Navigation Probe(Pointer Probe)Standard Tool Holder(Guider)Microdrive HolderOptical Sensor (OpticalDistance Sensor andOptical 3D scanner)Fiducial markers HeadholderFrame RegistrationPlates Frame AdapterHead Holder Adapter	Navigation probeStandard tool holderEndoscope holderMicrodrive holderOptical sensor Fiducialmarkers Head holderLeksell frame registrationplatesCRW FrameHead Holder Adapter	DifferentBoth the subject deviceand predicate deviceshares similarcomponents or associatedequipment, only thepredicate device containsthe endoscopic module,and the difference willnot affect the use of thedevice and will not affectand raise new risksrelated to safety andeffectiveness of thedevice.
PatientImmobilization	Yes - The device isattached to the headholder or the frame viaanadaptor	Yes - The device isattached to the headholder or the frame via anadaptor	Same
Device Mobility	Yes - Mobile standswith wheels; Roboticstand immobilizedwith stabilization feet	Yes - Mobile standswith wheels; Roboticstand immobilizedwith stabilization feet	Same
Vigilance System	Yes - foot pedal	Yes - foot pedal	Same
Sterile	Non-sterile and sterileinstrumentsDisposable steriledrapes for the roboticarm and touch screen	Non-sterile and sterileinstrumentsDisposable steriledrapes for the roboticarm and touch screen	Same
Single-Use	No	No	Same
Ac Powered	Yes	Yes	Same
Electrical SafetyTesting	IEC 60601 SeriesofStandards	IEC 60601 SeriesofStandards	Same

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5.7 Non-Clinical Performance Data

To demonstrate safety and effectiveness of Sinovation and to show substantial equivalence to the predicate device, Sinovation completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Sinovation 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:

Risk Assessment of the Biocompatibility per ISO 10993-1 Requirements Met ●
Cytotoxicity testing per ISO 10993-5 Passed ●
Sensitization testing per ISO 10993-10 Passed ●
Electrical safety testing per IEC 60601-1 Passed ●
Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed ●
Usability per IEC 60601-1-6 Demonstrates the usability was considered during design ●
Usability per IEC 62366-1 Demonstrates the usability was considered during design ●
Software verification and validation per IEC 62304/FDA Guidance results ● /conclusion
Safety of Laser Products per IEC 60825-1 Passed ●
Sterilization validation - demonstrates SAL of 10-6
Shelf Life Testing Supports shelf life of 10 years ●
Transportation Testing per ASTM D4169 Demonstrates package integrity maintained ● Sinovation also conducted the accuracy tests and the data as reported in Table 5.2 below:

Device Performance	Mean	Standarddeviation	Confidence interval at99% confidence level
Positional accuracy [mm]	0.613	0.197	1.205
Angular accuracy [degree]	0.439	0.241	1.163

Table 5.2 Accuracy Testing Results

5.8 Statement of Substantial Equivalence

The Sinobot X1 has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Sinobot X1 is as safe and effective as the predicate device. Therefore, the Sinobot X1 is substantially equivalent to the predicate device.

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).