INTAI Surgery Navigation System by Intai Technology Corporation

The INTAI Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Device Description

The INTAI Surgery Navigation System, also known as an image guided system, is comprised of navigation cart, software and its accessories. The system uses wireless optical tracking technology to identify the position of instruments relative to the patient's anatomy and displays such position on preoperative or intraoperative images of the patient. The images can help guide the surgeons during spinal surgical procedures, such as spinal fusion. The software links all system components and provides several application modules for trajectory planning, image registration, instrument auto-identification and real-time navigation.

AI/ML Overview

The provided text describes the regulatory filing for the "INTAI Surgery Navigation System." While it outlines various non-clinical tests performed, it explicitly states that no clinical testing has been conducted (Section 5.7). Therefore, the device performance is evaluated based on system performance validations that use cadavers, not human clinical data.

Here's a breakdown based on the information provided:

1. Table of acceptance criteria and the reported device performance:

Test	Acceptance Criteria	Reported Device Performance
System Performance Validation	Mean positional error ≤ 3.0 mm	Tested in cadaver, against the acceptance criteria. (Specific numerical result not provided, only that it "is validated in cadaver against the acceptance criteria")
	Mean trajectory angle error ≤ 3.0 degrees	Tested in cadaver, against the acceptance criteria. (Specific numerical result not provided, only that it "is validated in cadaver against the acceptance criteria")

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

Sample Size: Not explicitly stated for the "System Performance Validation." It only mentions "cadaver" (singular or plural not specified, implying a limited number, potentially one or a few for testing. Given the lack of clinical data, this would be a lab-based, not patient-based, test set.).
Data Provenance: The testing was "in cadaver." No country of origin is specified for the cadavers, but the applicant's address is Taiwan. This is a non-clinical, simulated use scenario, not real patient data. It is inherently prospective in the sense that the tests were designed and executed to validate the device.

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

Not Applicable. The ground truth for the "System Performance Validation" in cadavers would likely be established through precise physical measurements (e.g., using a coordinate measuring machine or highly accurate calibration tools) relative to the known anatomical structures or fiducials on the cadaver, not through human expert interpretation of images for diagnostic purposes. The document does not mention experts establishing ground truth for this non-clinical test.

4. Adjudication method for the test set:

Not Applicable. As the ground truth is established through physical measurements in a laboratory setting on cadavers, there is no expert adjudication process over human interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. The document explicitly states "No clinical testing has been conducted." An MRMC study involves multiple human readers evaluating medical images, often with and without AI assistance, to assess diagnostic performance. This was not performed.

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

Yes, implicitly. The "System Performance Validation" and "Accuracy" sections describe tests of the device's inherent positional and trajectory accuracy. These tests evaluate the system's ability to precisely track and guide instruments, which is a standalone function of the algorithm and hardware, independent of a human operator's diagnostic decision-making. The acceptance criteria for mean positional error and mean trajectory angle error are quantitative measures of the system's output.

7. The type of ground truth used:

For the "System Performance Validation," the ground truth would be physical measurements/gold standard metrology in a cadaveric setting, rather than expert consensus on medical images, pathology, or clinical outcomes data. This is a measure of mechanical and algorithmic precision.

8. The sample size for the training set:

Not specified. The document does not provide details about model training, as it focuses on the regulatory submission and validation of a navigation system, not an AI diagnostic algorithm. While navigation systems use algorithms, the training dataset size for any internal models used (if applicable, e.g., for image registration algorithms) is not disclosed.

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

Not specified. Given the information provided, this question is not directly applicable as the document does not detail the training of an AI model in the conventional sense for diagnostic purposes. The ground truth for system accuracy validation is based on physical measurement, not data-driven machine learning ground truth labeling.

Summary

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September 20, 2019

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.

Intai Technology Corporation Shih-Chang Chuang Manager No. 9 Jingke Rd., Nantun Dist., Taichung City, 40852 TW

Re: K180523

Trade/Device Name: INTAI Surgery Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 21, 2019 Received: August 23, 2019

Dear Shih-Chang Chuang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K180523

Device Name INTAI Surgery Navigation System

Indications for Use (Describe)

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

5.1. Submitter's information

Applicant name	INTAI Technology Corporation
Address	No. 9, JingKe Rd., Nantun Dist., Taichung City 40852, Taiwan(R.O.C.)
Telephone number	+886-4-2359-5336
Contact person	Teng-Kuan Tsai
Date prepared	August 15, 2019

5.2. Device information

Device name	INTAI Surgery Navigation System
Trade name	INTAI Surgery Navigation System
Common name	Surgery Navigation System for Spine
Classification name	Orthopedic Stereotaxic Instrument
Classification	Class II (21 CFR 882.4560)
Product code	OLO
Predicate device	Medtronic StealthStation System (K133444)Primary product code: HAWSecondary product code: OLO

5.3. Device description

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Compatible Systems	Device Name	510(k) Number
Pedicle screw	Wiltrom spinal fixation system	K172548
C-arm	Siemens Arcadis Varic	K040066
C-arm	GE OEC Fluorostar	K043076
C-arm	Ziehm Imaging Ziehm Solo	K092438

5.4. Intended use/Indications for use

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

5.5. Substantial equivalence comparison
The subject device has the same intended use and technological characteristics as the predicate device. Below is a comparison of the indications for use and technological characteristics of subject device to the predicate device and an assessment of the equivalence of each characteristic. It is shown that technological differences in the subject device do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.

	Subject Device	Predicate Device	Equivalence Assessment
Device name	INTAI Surgery Navigation System	Medtronic StealthStation System	N/A
Submitter	INTAI Technology Co.	Medtronic Navigation, Inc.	N/A
510(k) number	TBD	K133444	N/A
Primaryproduct code	OLO	HAW	N/A
Secondaryproduct code	N/A	OLO	N/A
	Subject Device	Predicate Device	Equivalence Assessment
Indications foruse	The INTAI Surgery NavigationSystem is indicated for precisepositioning of surgicalinstruments or spinal implantsduring general spinal surgerywhen reference to a rigidanatomical structure, such as thevertebra, can be identifiedrelative to a patient'sfluoroscopic or CT imagery. It isintended as a planning andintraoperative guidance systemto enable open or percutaneousimage guided surgery by meansof registering intraoperative 2Dfluoroscopic projections topre-operative 3D CT imagery.Example procedures include butare not limited to:Posterior-approach spinalimplant procedures, such aspedicle screw placement, withinthe lumbar region.	The StealthStation System isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures, The StealthStationSystem is indicated for anymedical condition in which theuse of stereotactic surgery maybe appropriate, and wherereference to a rigid anatomicalstructure, such as the skull, along bone, or vertebra, can beidentified relative to a CT or MRbased model, fluoroscopyimages, or digitized landmarks ofthe anatomy.	EquivalentThe scope of indications for useof subject device is entirelycontained within that ofpredicate device. The subjectdevice does not have any newindications for use.
Operatingprinciple	The subject device creates arelative position between thepatient and 2D C-arm images bymeans of capturingintra-operative 2D C-arm imagesof the patient. The relativeposition between the patient and3D CT images is establishedthrough the registration ofintra-operative 2D C-arm imagesto pre-operative 3D CT images.Subsequently, the subject devicecan continuously display therelative position of a trackedinstrument to a representation ofthe patient's anatomy. Thesurgeon can utilize thisinformation as a guide toperform either open orpercutaneous spine surgery.	The navigation system creates atranslation map between pointsin the patient anatomy and thecorresponding points onradiologic images of the patient.Once this map is establishedthrough a process calledregistration), the software candisplay the relative position of atracked instrument to arepresentation of the patient'sanatomy.During surgery, the system tracksthe position of specializedsurgical instruments in or on thepatient anatomy andcontinuously updates theinstrument position on theseimages either by optical trackingor electromagnetic tracking.	EquivalentBoth subject device andpredicate device are intended toestablish the relative positionbetween the tracked instrumentand patient's anatomy. Thesubject device utilizes the sameoptical tracking system as thepredicate device.
Main systemcomponents	Optical trackerNavigation cart, including opticaltracker, medical panel PC andarticulating arms	Optical and electromagnetic(AXIEM)localization systemStaff cart (optical system),including camera and articulatingarms, and surgeon cart, includingsurgeon monitor and articulatingarms	EquivalentThe function of optical tracker,i.e. optical tracking, is equivalentto that of optical localizationsystem. The subject device doesnot have electromagneticlocalization system.EquivalentThe subject device integratesoptical tracker and medical panelPC into a cart. The function ofnavigation cart is equivalent tothat of staff cart and surgeoncart.
	N/A	Keyboard and mouse	Equivalent

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	Subject Device	Predicate Device	Equivalence Assessment
Main systemcomponents	No touch reader	N/A	EquivalentNo touch reader is used toautomatically identify theinstruments. User shall manuallyidentify the instrument whenusing the predicate device.
Patienttracking	Dynamic reference frame (DRF)	Dynamic referencing	Identical
Operatingsystem	Windows 7	Debian Linux	EquivalentThe function of navigationsoftware is successfully verifiedon Windows' platform, whichdoes not affect its operation.
Modes ofoperation	Planning & Navigation Module1. Procedure approach (next/lastbuttons) software for guidingsurgical navigation2. Display of 3D image andmulti-planar reconstructionimage3. Localization of patient'sposition by DRF4. Anatomical images"Instrument view" at differentdepths from the viewpoint ofinstrument tip5. "Instrument navigation panel"for trajectory planning	Planning & Navigation Module1. Procedure guided software(next/back buttons) with voiceprompt, instruction windowand task visualization2. Advanced 3-D modelingcapabilities for multiplemodels or plans3. PatienTrak dynamicreferencing4. User definable "Look-Ahead"views and display setup5. Display of the 3D accuracy"Zone"6. Linear measurement tools inall planes for anatomical sizing7. 3D guidance view with depthdisplay8. Screen export as PCcompatible JPEG file onCD-ROM	EquivalentThe subject device does not havethose modules incorporated inthe predicate device, i.e. module5, 6 and 8. These modulesprovide optional functions anddo not affect the overallnavigation procedure.
Registration1. C-arm/CT image registration2. Minimally invasive surgery forlumbar spine		Advanced Contour Registration1. Registration is achieved bydragging probe acrossvertebral body2. For use in cervical, thoracicand lumbar spine3. Enabling technology forminimal access spine surgery	EquivalentBoth subject device andpredicate device needregistration to establish spatialcoordinate transformation.
Supportedimagemodalities	CT	CT or MR	EquivalentThe subject device uses the sameCT image modality as thepredicate device.

5.6. Non-clinical testing

Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions. Below is a summary of all performance tests carried out on the subject device. It is demonstrated that the subject device performs as safely and effectively as the predicate device.

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Test	Description
Cleaning	Cleaning of those reusable accessories is validated inaccordance with AAMI TIR30:2011/(R)2016, ASTM F3293-18and FDA guidance for the “Reprocessing medical devices inhealth care settings: Validation methods and labeling” issued onMarch 17, 2015.
Sterilization	Moist heat sterilization of those reusable accessories isvalidated in accordance with ISO 17665-1:2006.
RepeatedReprocessing	Reliability of those reusable instruments after repeatedreprocessing is validated throughout their use-life.
Biocompatibility	Biocompatibility of those accessories that come into contactwith patient is evaluated in accordance with FDA guidance forthe use of international standard ISO 10993-1, “Biologicalevaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process” issued on June 16, 2016 andISO 10993-1:2009.
Software	Software is verified and validated in accordance with FDAguidance for the content of premarket submissions for softwarecontained in medical devices issued on May 11, 2005 and IEC62304:2006 + A1:2015.
Electrical Safety	Electrical safety of the system is complied with therequirements of ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
ElectromagneticCompatibility	Electromagnetic compatibility of the system is complied withthe requirements of IEC 60601-1-2:2014.
Usability	Usability of the system is validated in accordance withANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC60601-1-6:2010 + A1:2013.
Accuracy	Positional accuracy of the system is evaluated in accordancewith ASTM F2554-10.
SystemPerformanceValidation	Clinical accuracy of the system is validated in cadaver againstthe acceptance criteria of mean positional error $≤$ 3.0 mm andmean trajectory angle error $≤$ 3.0 degrees.
Risk Assessment	The effectiveness of all risk control measures is verified inaccordance with ISO 14971:2007

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Test	Description
DesignVerification	The design output fulfills all design input requirements.
User Needs	The system meets the needs of the end user under simulated use conditions.

5.7. Clinical testing

No clinical testing has been conducted.

5.8. Conclusions

The results of all non-clinical tests demonstrate that the INTAI Surgery Navigation System performs as safely and effectively as the legally marketed predicate device. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its indications for use and technological characteristics.

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).