The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.

INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.

Device Description

INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure.

INLIANT includes a stand-alone cart which provides mobility and structural support for the computer, monitor and the camera which consists of two high resolution optical image sensors and lens assemblies. The system also includes the handpiece (model WI-75 LED G cleared under K080939), Patient Trackers and Fiducial Kit.

Operation of INLIANT is based on optical tracking. Stereoscopic images of the markers on the Patient Tracker and a handpiece are captured by the camera above the surgical site. INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.

AI/ML Overview

The submitted document describes the K213392 510(k) summary for the INLIANT® Surgical Navigation System. This device is a computerized navigational system intended for dental implantation procedures, assisting in pre-operative planning and intra-operative guidance. The primary purpose of the validation study was to demonstrate substantial equivalence to a predicate device (K150222, X-Guide Surgical Navigation System) in terms of accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comparison table (page 5-6) outlining performance characteristics. The critical performance characteristic for this device is its accuracy at the drill tip.

Acceptance Criteria	Reported Device Performance (INLIANT)	Predicate Device Performance (X-Guide)
Accuracy at the Drill Tip	≤1.0mm	≤1.0mm
Presentation Update Rate	Real time	Real time

Note: The document explicitly states that the INLIANT system performed identically to the predicate device in terms of "Accuracy at the Drill Tip" and "Presentation Update Rate." The clinical study (described below) then aimed to confirm that the angular non-inferiority was met compared to the predicate's performance against freehand.

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

Sample Size: A total of 23 implants were placed among 22 adult subjects in the clinical performance study.
Data Provenance: The study was a single-clinic, confirmatory, non-randomized study. The subjects were dental clinic patients. The document does not explicitly state the country of origin, but given the FDA submission, it's typically assumed to be within the US or a region with comparable regulatory standards. The study appears to be prospective as it involved placing implants and following patients post-surgery.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications for the clinical performance study. It states that "Four investigators used INLIANT to place the dental implants." These investigators are presumably qualified dental professionals, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication method for the test set

The document does not describe an explicit adjudication method for the test set, such as 2+1 or 3+1 consensus. The ground truth (deviations between planned and placed implant positions) was established by "registering pre-operative and post-operative CBCT scans in a common reference," suggesting an objective measurement process rather than a subjective expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The study was a clinical performance study of the device (INLIANT), not a multi-reader, multi-case study comparing human readers with and without AI assistance. The study's objective was to confirm the device's accuracy and non-inferiority to the predicate device by measuring implant deviations, rather than assessing human reader performance improvement. The "AI" component here is the navigational system assisting a human operator, not a diagnostic AI analyzing images by itself or providing a read.

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

This device is a surgical navigation system, inherently designed for human-in-the-loop use. It provides real-time guidance to a clinician during a procedure. Therefore, a standalone (algorithm only) performance assessment would not be relevant or feasible for this type of device. The accuracy assessment (≤1.0mm drilling accuracy) is a system-level performance metric that includes the device's software and hardware in operation.

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

The ground truth for the clinical performance study was primarily objective measurements based on imaging data. Specifically, "lateral (coronal and apical) and angular deviations between the pre-planned implant positions and actual implant positions were measured by registering pre-operative and post-operative CBCT scans in a common reference." This method uses the physically placed implant's position as "ground truth" compared to the pre-planned position.

8. The sample size for the training set

The document does not provide a sample size for a "training set." This device is a surgical navigation system, not a machine learning model that typically undergoes a distinct training phase with a labeled dataset in the same way an image classification AI would. It's an engineered system with algorithms for real-time tracking and guidance. Its development would involve engineering design, calibration, and verification, rather than "training" on a large dataset of patient cases to learn to perform a task.

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

As there is no "training set" in the context of a machine learning model, the concept of establishing ground truth for it does not apply in this document. The device's performance is validated through non-clinical bench testing (e.g., performance testing to evaluate tolerance analysis, latency, positional and tracking accuracy per ASTM F2554) and the clinical study described. The ground truth for these non-clinical tests would involve highly controlled experimental setups with known reference points and precise measurement instruments.

Summary

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Navigate Surgical Technologies Inc. % Pamela Buckman Regulatory/Clinical Consultant Pamela Buckman, MSN 921 Calle Verde Martinez, California 94553

Re: K213392

Trade/Device Name: INLIANT® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 23, 2021 Received: November 26, 2021

Dear Pamela Buckman:

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.

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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 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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213392

Device Name INLIANT® Surgical Navigation System

Indications for Use (Describe)

INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.

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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510(k) Summary K213392

General Information

Date Prepared: February 22, 2022

Proprietary Name: INLIANT® Surgical Navigation System

Common Name: Dental Stereotaxic Instrument

Classification Name: Bone Cutting Instrument and Accessories

Regulation: 21 CFR 872.4120

Regulatory Class: Class II

FDA Panel: Dental

Product Code: PLV

Applicant:

Navigate Surgical Technologies, Inc. 25 E 6th Ave, Suite 302 Vancouver, BC V5T 1J3 Marty Dymek, CEO marty@navigatesurgical.com

Contact: Pamela M. Buckman, MSN 921 Calle Verde Martinez, CA d4553 925 980 7007 (mobile) pmbuckman@gmail.com

Indication for Use: The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both the pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.

INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.

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Predicate Device: K150222 (X-Guide Surgical Navigation System)

Device Description: INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure.

Comparison of Technological Characteristics: The INLIANT Surgical Navigation System (INLIANT) and the predicate device, X-Guide Surgical Navigation System (X-Guide), provide three-dimensional (3D) orientation and position of surgical tools displayed on a computer monitor in real-time within a patient's 3D imaging data set (CT images). Both systems utilize a dynamic computer-assisted surgery system based on optical motion tracking technology which tracks the position of the surgical tool to a sub-millimeter accuracy relative to the position of the patient throughout dental implant osteotomy preparation. Neither device is intended to replace human assessment, but to provide objective information relating to the positioning and alignment of the surgical tools in reference to the patient's anatomy.

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INLIANT and the predicate device share many characteristics. These characteristics are provided in the following table:

Characteristic	INLIANT (subject)	X- Guide(predicate)	Comparison/Conclusion
Indications for Use	INLIANT is acomputerizednavigational systemintended to provideassistance in boththe pre-operativeplanning and theintra-operativesurgical phase ofdental implantationprocedures.INLIANT providessoftware to pre-operatively plandental implantationprocedures andprovidesnavigationalguidance of surgicalinstruments. Thedevice is intendedfor use for partiallyedentulous adultpatients who requiredental implants aspart of theirtreatment plan.	The X-GuideSurgical NavigationSystem is acomputerizednavigational systemintended to provideassistance in boththe pre-operativeplanning phase andthe intra-operativesurgical phase ofdental implantationprocedures. Thesystem providessoftware to pre-operatively plandental implantationprocedures andprovidesnavigationalguidance of thesurgicalinstruments. Thedevice is intendedfor use for partiallyedentulous andedentulous adultand geriatricpatients who needdental implants aspart of theirtreatment plan.	The INLIANT is notintended for fullyedentulous patients orgeriatric patients asindicated in the predicate.The exclusion of fullyedentulous patients andgeriatric patients does notimpact substantialequivalence as theINLIANT intended for useon a subset of the patientpopulation of thepredicate, partiallyedentulous patients.
Main Functions	CT-based implantplacement planning.Presentation ofposition, angle, anddepth indicatorswhen drilling in thejaw.	CT-based implantplacement planning.Presentation ofposition, angle anddepth indicatorswhen drilling in thejaw.	Identical
Characteristic	INLIANT (subject)	X- Guide(predicate)	Comparison/Conclusion
Performance Characteristics
Accuracy at theDrill Tip	$\leq1.0mm$	$\leq1.0mm$	Identical
Presentation UpdateRate	Real time	Real time	Identical
Technological Characteristics
Input ImagingModality	ComputerizedTomography	ComputerizedTomography	Identical
Dynamic ObjectPose MeasurementTechnology	Stereoscopictriangulation ofmarker patterns.	Stereoscopictriangulation ofilluminatedchecker-boardpatterns (X-Corners).	Equivalent
Hand piece tracking	Optical markerpatterns on thehand piece.	An opticallymarked tube-likeattachment to theback of the handpiece.	Equivalent
Jaw TrackingAttachment	INLIANT Fiducialis a nonconductiveplastic piece withembeddedradiopaque spheres.Moldedthermoplastic isinserted into theINLIANT Fiducialtray and placed onavailable dentitionto form the Stent.During surgery,Patient Tracker(optically marked)is connected to theFiducial	U- shaped "X-clip"with a moldedthermoplastic insert,mounted on theavailable dentition.During surgery, ametallic arm holdingan optically markedmetal cylinder isconnected to it.	Equivalent.In both systems, athermoplastic part ismolded to the surface ofthe jaw to provide acoupling to the teeth withthe optically trackedobject rigidly connectedto the molded part.
Patient to CT ImageRegistration	Automatic, usingsmall radiopaquespheres embeddedin a uniquelyshaped,nonconductiveplastic piece	Manual, using smallfiducial spheresembedded in the X-clip and a jawtracker calibrationprocess.	Equivalent.In both systems, fiducialobjects of known shapesare used to obtain aregistration mappingbetween the patient jaw
			and the CT image.
Jaw AttachmentCalibration	Not needed	Needed prior toeach operation.Differentproceduresdepending on thetype of attachment.	Equivalent.INLIANT markerson Patient Trackerare permanent andpre- calibrated.
Characteristic	INLIANT (subject)	X- Guide(predicate)	Comparison/Conclusion
Drill lengthmeasurement	Drill lengthmeasurement isdone by touching apoint on the PatientTracker. Drilllengthmeasurement isfollowed by"anatomy check" toconfirm system'saccuracy. Drilllengthmeasurement isdone after everydrill change.	Initial hand piececalibration is doneusing hand piececalibration disc (aspecial opticallymarked tool) whiledrill bit lengthcalculation is doneby touching a pointon a Go-plate(another opticallymarked tool). Drilllengthmeasurement isfollowed by"anatomy check" toconfirm system'saccuracy. Drilllength measurementis done after everydrill change.	Equivalent.INLIANT markers onhand piece arepermanent and pre-calibrated. PatientTracker is used toperform the drill lengthmeasurement.
Mount Configuration	Mobile cart	Mobile cart	Identical
Presentation ofNavigation Guidance	3D graphicspresentation of drillposition, angle anddepth relative toplanned placement.	3D graphicspresentation of drillposition, angle anddepth relative toplanned placement.	Identical
llumination oftracking targets	Visible lightemitted by existingdental light oroperatory lighting.	Visible lightemitted by LEDpanel	Equivalent

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Non-Clinical Testing: Device testing was conducted to evaluate conformance to product specifications and applicable standards. Conclusions drawn from these non-clinical tests demonstrate that INLIANT is substantially equivalent to the predicate device. The following standards were applied:

Guidance on Premarket Notification [510(k)] Submissions for Medical Devices ●
EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for . regulatory purposes
EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
IEC 62304:2006 Medical device software. Software life cycle processes ●
IEC 62366:2008 Medical devices. Application of usability engineering to medical devices
. IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for safety --● Collateral Standard: Usability

Bench Testing:

Software Validation and documentation for software of moderate level of concern was provided per . the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All software verification/validation passed.
Cybersecurity Evaluation per the FDA Guidance Document "Content of Premarket Submissions for ● Management of Cybersecurity in Medical Devices."
Cleaning and disinfection validations were performed in accordance with FDA Guidance document ● "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. All testing passed.
Steam Sterilization Validation was conducted in accordance with ANSVAAMI/ISO 17665-1, ISO . 17665-2, and ANSI/AAMI ST79. All testing passed.
Gamma radiation validation per ISO 11137-1 and -2 and shelf life/package integrity validation per . ISO 11607-1, ASTM F2096, and ASTM F88.
. Biocompatibility assessment and testing was conducted per FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The patient contacting components of the device passed cytotoxicity, sensitization, intracutaneous irritation, and oral mucosa irritation biocompatibility testing.
. Performance testing was conducted to evaluate the tolerance analysis, latency, positional and tracking accuracy per ASTM F2554, tracker environmental conditions, drill length measurement accuracy, system verification, and design validation. The acceptance criteria were met.

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Usability Testing: A usability validation testing included 8 participants from 8 clinics. The study was conducted at Navigate Surgical Technologies Inc, in a simulated dental clinic operatory. Observational data were collected during the testing and participants completed a questionnaire. Analysis of the data demonstrated that the INLIANT System's user interface performed as expected for the intended users, uses, and use environments, and that no further modification to the user interface was necessary.

Animal testing: No animal testing was conducted or included in support of the INLIANT submission.

Clinical Performance: Clinical testing was performed. The purpose of the clinical study was to confirm that the corrective actions identified in the Root Cause Analysis successfully reduce the angular inaccuracy of dental implants placed using the INLIANT device in a clinical setting. Specifically, it is designed to confirm that the INLIANT device is equivalent to the predicate device by measuring the angular and lateral deviations between the planned and placed implant positions. The study employed a confirmatory, single-clinic, non-randomized study of the INLIANT device to aid dental implant placement. A total of 23 implants were placed among 22 adult subjects. The subject population were dental clinic patients, male and female adults age 22 years and older in good general health in need of 1-2 implants with each tooth having at least two adiacent zero mobility teeth in the same arch on which surgery was to be performed. Four investigators used INLIANT to place the dental implants. Deviations between the planned implant positions and placed implant positions were measured. The study endpoints were evaluated by the lateral (coronal and apical) and angular deviations between the pre-planned implant positions and actual implant positions were measured by registering pre-operative and post-operative CBCT scans in a common reference. Patients were followed up 2-4 weeks postsurgery.

The primary study research question inquired as to the probability of having all three of the lateral and angulation measurements be statistically less than their respective noninferiority upper equivalence bounds that preserve 80% of the advantage of the predicate device compared to freehand. These bounds are 3.903° for angular deviation, 0.8661 mm for coronal lateral deviation, and 1.145 mm for apical lateral deviation. Results for all three types of deviations support the conclusion that the deviations are significantly different than their respective upper equivalence bound, and non-inferior to the predicate. There were no adverse events reported.

CONCLUSION

The summary includes the conclusions drawn from the nonclinical and clinical tests demonstrate that the device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.