Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.

Device Description

Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined package for performing both pre-operative planning and guided implant insertion. Using preacquired CT scan of the jaw, Navident provides the dentist (usually a GP dentist, prosthodontist, periodontist or dental surgeon) with implantation planning and real-time guidance during dental implants insertion.

The guidance function of Navident is primarily provided using a visualization of the drill pose (tip location and shaft axis direction) relative to the desired pose of the implant, as planned on a preacquired CT image of the jaw. This visualization assists the dentist in implementing their implantation plan.

Navident consists of four main components:

1. A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
1. A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
1. A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
1. An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Navident device, based on the provided text:

Navident Device Performance and Acceptance Criteria

Acceptance Criteria	Reported Device Performance
Accuracy at the drill tip	≤ 1.0 mm
Presentation update rate	Real time
System immunity to electromagnetic interference (acc. IEC 60601-1-2)	System passed all tests while providing accurate drilling guidance
Sterilization of reusable components (acc. ISO 17665-1:2006)	Validated to reach acceptable sterility assurance level
Biocompatibility (acc. ISO 10993-1, 10993-5, 10993-10)	Met all acceptance criteria for cytotoxicity, hypersensitivity, and irritation

Study Details Proving Acceptance Criteria

Due to the nature of the provided document (a 510(k) summary), specific details for some categories (like distinct training vs. test sets or formal MRMC studies) are not fully separated as might be found in a later clinical trial report. However, the summary describes various performance and clinical evaluations.

Table of Acceptance Criteria and Reported Device Performance: (See table above)
Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: Performed with various settings and conditions (e.g., different image voxel sizes, distances, lighting, random jaw models). The exact number of "tests" or "samples" for each specific parameter is not quantified.
- Human Factors/Usability Summative Evaluation: 15 representative users (oral surgeons, general dental practitioners).
- Clinical Case Data: 21 cases with 36 guided implantations. The geographical provenance (country of origin) is not explicitly stated but implies international, as it mentions "a diverse international group of surgeons." This appears to be retrospective collected over time as "feedback on usage history."
- Clinical Evaluation (Systematic Feedback): 7 surgeons who treated a total of 150 patients. The provenance is again "diverse international group of surgeons" and appears to be retrospective collection of "usage history and professional impressions."
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- For the human factors/usability evaluation, 15 "representative users (i.e., oral surgeons, general dental practitioners)" were observed. Their role was more as "test subjects" or "users" rather than establishing a separate "ground truth" in terms of clinical outcomes, though their feedback contributed to the "usability problems" assessment.
- For the clinical case data and systematic feedback, the ground truth regarding "accuracy averaging 1.0mm deviation from plan at both entry and apex" was likely established through post-procedure analysis by the "experienced user" (qualified dental surgeon) themselves or by the study investigators. The qualifications of these 7 surgeons and the "diverse international group of surgeons" are defined as "qualified dental surgeon." No specific number of independent experts for ground truth adjudication is given for the accuracy assessment, rather it describes "an experienced user is able to achieve."
Adjudication Method for the Test Set:
- No formal multi-reader adjudication method (e.g., 2+1, 3+1) is described for the clinical accuracy assessment. The summary states, "Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex." This implies a measurement against the pre-planned position, which serves as the "ground truth" for deviation.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study, specifically comparing human readers with AI vs. without AI assistance, is mentioned. The device is a "computerized dental navigational system" providing real-time guidance, not an AI diagnostic aid that assists human readers in interpreting images. Its direct comparison is against a predicate surgical navigation system.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "Full system bench testing" (point 3 under SUMMARY OF PERFORMANCE TESTING) evaluates the "Overall accuracy of the system in mapping the drill tip to the CT image" and other operational aspects without direct human surgical intervention as the primary performance metric. This represents the standalone performance of the navigation system's mapping and guidance precision.
The Type of Ground Truth Used:
- Bench Testing: Engineering measurements against known physical standards or simulated conditions.
- Clinical Cases (Accuracy): Deviation from the "planned pose of the implant" as visualized on the pre-acquired CT image. The pre-planned position serves as the ground truth for measuring positional / angular deviation.
- Clinical Cases (Outcomes): "No significant patient adverse events or complications were reported." This relies on outcomes data from the surgeons.
The Sample Size for the Training Set:
- The document describes a "510(k) summary," which focuses on demonstrating substantial equivalence and performance testing rather than algorithm development. It does not provide details on a specific "training set" for an AI algorithm. The device is a mechanical/software navigation system, not primarily an AI deep learning model that requires a large training dataset in the conventional sense. The "training" here refers to its design and calibration processes.
How the Ground Truth for the Training Set was Established:
- Not applicable in the context of an AI training set. The "ground truth" for the system's design and calibration would have been engineering specifications and physical measurements, ensuring its tracking capabilities (Stereoscopic triangulation of illuminated checker-board patterns) and mapping accuracy.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 8, 2016

ClaroNav Inc. Doron Dekel CEO 1140 Sheppard Avenue West, Unit 10 Toronto, Ontario M3K 2A2 Canada

Re: K161406

Trade/Device Name: Navident Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: August 9, 2016 Received: August 15, 2016

Dear Doron Dekel:

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. 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 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D.

Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161406

Device Name

Navident

Indications for Use (Describe)

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

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

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Image /page/3/Picture/0 description: The image contains the logo for ClaroNav. The logo features a black and white circular design on the left side, resembling a stylized target or radar. To the right of the circular design, the text "ClaroNav" is displayed in a bold, sans-serif font. The text is positioned above a solid black rectangle, creating a contrasting visual element.

510(k) SUMMARY

SUBMITTER INFORMATION

Company Name:	ClaroNav Inc.
Company Address:	1140 Sheppard Avenue West - Unit 10Toronto, OntarioCanada - M3K 2A2
Company Phone:	(647) 951-1525
Company Fax:	(647) 951-1524
Contact Person:	Doron Dekel, CEO
Date Summary Prepared:	September 2 , 2016

DEVICE IDENTIFICATION

Trade/Proprietary Name:	Navident
Classification:	II
Generic Device Name:	Surgical Navigation System
Product Code:	PLV
Classification Names:	Bone Cutting Instrument and Accessories
Classification Regulation #:	CFR 872.4120
Classification Panel:	Dental
Predicate Devices:	X-Guide Surgical Navigation System (K150222)

DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, with the text "ClaroNav" in black on a white background to the right of the design. A black bar is located underneath the text.

Navident consists of four main components:

1. A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
1. A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
1. A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
1. An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.

To allow Navident to provide accurate guidance, the dentist fits the NaviStent retainer to the patient's jaw in a chair-side process. The fit can be evaluated to ensure predictable results.

A special CT-Marker is connected to the NaviStent, and the patient is CT-scanned with the NaviStent in place, as with any CT-guide stent. The CT data is loaded into Navident and an implant plan is prepared by the surgeon.

Prior to start of drilling for implants, NaviStent is placed in the patient's mouth, the DrillTag is latched on the tag adapter, and the drill axis location is calibrated in a single motion. When a new drill is inserted, its length and exact tip position are calibrated by touching a dimpled point on the JawTag prior to inserting it into the mouth.

During surgery, Navident automatically tracks the handpiece's motions. When the drill approaches a pre-planned implant location, Navident provides a cross-hairs dynamic visualization of the drill pose relative to the planned pose of the implant. This visualization guides the hand motions of the surgeon towards locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When not near a marked implantation path, Navident provides real-time visual feedback showing the bone densities in the region in front of the drill's tip.

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Image /page/5/Picture/0 description: The image contains the logo for ClaroNav. The logo features a stylized circular design on the left, composed of black and white sections. To the right of the circular design, the text "ClaroNav" is displayed in a bold, sans-serif font. A horizontal black bar runs beneath the text, creating a contrasting visual element.

INDICATIONS FOR USE

Navident has the following Intended Use:

SUBSTANTIAL EQUIVALENCE

Navident shares technological, performance and clinical features and has substantially equivalent intended use as the X-Guide Surgical Navigation System:

PredicateCompany	PredicateTrade Name	510(k) #	Predicate Indications for Use
X-NAVTechnologies	X-GuideSurgicalNavigationSystem	K150222	The X-Guide ® Surgical Navigation System is acomputerized navigational system intended to provideassistance in both preoperative planning phase andintra-operative surgical phase of dental implantationprocedures. The system provides software topreoperatively plan dental implantation proceduresand provides navigational guidance of the surgicalinstruments. The device is intended for use forpartially edentulous and edentulous adult and geriatricpatients who require dental implants as part of theirtreatment plan.

Comparison of Technological Characteristics

Navident shares many clinical, technological and performance characteristics with a predicate device, the X-Guide Surgical Navigation System. These characteristics are outlined in the following table:

Feature/Characteristic	X-Guide (predicate)	Navident	Rationale for any differences
Intended Use
Class/ProductCode/ClassificationName	Class II/ PLV/ 21 CFR872.4120 ( (Bone CuttingInstrument and Accessories)	Class II/ PLV/ 21 CFR872.4120 ( (Bone CuttingInstrument and Accessories)	Same
	The X-Guide® Surgical	Navident is a computerized	Since Navident's indications are
Indications for Use	The X-Guide® SurgicalNavigation System is acomputerized navigationalsystem intended to provideassistance in both thepreoperative planning phaseand the intra-operative surgicalphase of dental implantationprocedures. The systemprovides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments. Thedevice is intended for use forpartially edentulous andedentulous adult and geriatricpatients who need dentalimplants as part of theirtreatment plan.	Navident is a computerizeddental navigational systemintended to assist preoperativeplanning and to guide drilling ina patient jaw duringimplantation surgery, using pre-acquired CT scan of the jaw. Thedevice is intended for use by aqualified dental surgeon in thetreatment of partial edentulism.	a subset of the predicate's, eachcase in which Navident is used isindicated for the predicate aswell.
Main functions	CT-based implant placementplanning. Presentation ofposition, angle and depthindicators when drilling in thejaw.	CT-based implant placementplanning. Presentation ofposition, angle and depthindicators when drilling in thejaw.	Same
Use Environment	Dental clinic	Dental clinic	Same
Target Population	Adult and geriatric patients	Adult patients	Same
Users	Dental surgeon	Dental surgeon	Same
TechnologicalCharacteristics
Input imaging modality	CT	CT	Same
Dynamic object posemeasurementtechnology	Stereoscopic triangulation ofilluminated checker-boardpatterns (X-Corners).	Stereoscopic triangulation ofilluminated checker-boardpatterns (X-Points).	Similar technology with somedifferences in implementationdetails.
Handpiece trackingattachment	An optically marked tube-likeattachment to the back of thehandpiece.	Universal adapter for anyhandpiece with a visuallymarked lightweight disposableplastic tag.	Both systems provide a rigidhandpiece attachmentmechanism with somedifferences in implementationdetails.
Jaw trackingattachment	U-shaped "X-clip" with amolded thermoplastic insert,mounted on the availabledentition. During surgery, ametallic arm holding anoptically marked metalcylinder is connected to it.	"NaviStent" moldedthermoplastic sheet with anintegrated arm holding anoptically marked plastic tag.	In both systems, a thermoplasticpart is molded to the surface ofthe jaw to provide a coupling tothe teeth. In both systems, theoptically tracked object is rigidlyconnected to the molded part.Differences relate toimplementation details.
Patient to CT imageregistration	Manual, using small fiducialspheres embedded in the X-clip and a jaw trackercalibration process.	Automatic, using a removableCT Marker part containing aCT-visible fiducial body.	In both systems, fiducial objectsof known shapes are used toobtain a registration mappingbetween the patient jaw and theCT image. Navident uses anautomated process.
Jaw attachmentcalibration	Needed prior to eachoperation. Differentprocedures depending on thetype of attachment.	Not needed.	Navident's automatedregistration process eliminatesthe need for this step.
Drill tip calibration	Initial handpiece calibrationusing a special opticallymarked tool, plus tipcalibration by touching a pointafter each drill change.	Initial drill axis calibration, plustip calibration by touching apoint in a dimple after eachdrill change. Only the jaw tagis used.	The calibration steps are similar.However, the jaw tag is used inNavident to also perform thesecalibration steps, eliminating theneed for a separate tool.
Mount for camera anddisplay	Mobile cart weighing 130lbwith a large arm holdingcamera above patient's head.Screen is attached to cartpole.	Mobile cart weighing 55lbwith a folding arm holdingcamera and screen abovepatient's chest.	Similar.
Presentation ofnavigation guidance	3D graphics presentation ofdrill position, angle and depthrelative to planned placement.	3D graphics presentation ofdrill position, angle and depthrelative to planned placement.	Same
Illumination of trackingtargets	Visible light emitted by LEDpanel	Visible light emitted by LEDpanel (optional)	Same
PerformanceCharacteristics
Accuracy at the drill tip	≤1.0mm	≤1.0mm	Same
Presentation updaterate	Real time	Real time	Same

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Image /page/6/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a circular design on the left, which is divided into four quadrants with alternating black and white colors. To the right of the circular design, the text "ClaroNav" is displayed in a clear, sans-serif font. The text is positioned horizontally and appears to be aligned with the center of the circular design.

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Image /page/7/Picture/0 description: The image is a close-up of a black and white pattern. The pattern consists of a square in the upper left corner that is divided into black and white quadrants. To the right of the square is a circular pattern of concentric circles that are also divided into black and white sections. The overall effect is a high-contrast, geometric design.

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Image /page/8/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, with the text "ClaroNav" to the right of the design. The text is in a sans-serif font, with the first letter capitalized and the rest in lowercase. The background behind the text is divided horizontally, with the top half being white and the bottom half being black.

Navident's intended use for planning and guidance of drilling for dental implementations is identical to the intended use of the predicate device. Each clinical case indicated for Navident is indicated for the predicate as well. The components, performance and operational characteristics of Navident are very similar to those of the predicate device. Noticeable differences between the designs of Navident and the predicate device include:

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Image /page/9/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white circular design on the left, resembling a stylized target or compass. To the right of the design is the text "ClaroNav" in a bold, sans-serif font. Below the text is a solid black bar, creating a contrasting visual element.

. In the predicate, calibration of the drilling axis requires a separate procedure using a special tool, while Navident provides an automatically triggered process using a pin on the JawTag. Both provide the same mathematical result and use it in the same manner during guidance.
In the predicate, the user needs to manually calibrate the registration mapping between the patient jaw and its CT image by touching with a pointer small fiducial spheres placed near the jaw both during the CT scan and the surgery. Navident performs registration using fiducial objects placed near the jaw during the CT scan, and automates the process of computing the registration mapping. Both registration procedures produce the same mathematical result and use it in the same manner during guidance.
. Navident is mounted on a cart with an arm enabling the positioning of the optical tracker and screen above the patient's chest.

The above design differences relate solely to the usability aspects of the devices, not to the core functions they perform, which are substantially equivalent.

COMPLIANCE TO STANDARDS AND REGULATIONS

The following FDA approved standards are met by the Navident system as demonstrated through performance testing:

ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices

IEC 62366-1 Edition 1.0 2015-02, Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices

IEC 62304 First edition 2006-05, medical device software - software life cycle processes.

ISO 15223-1 Second Edition 2012-07-01, medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements.

ISO 10993-1 Fourth edition 2009-10-15, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. (Biocompatibility)

AAMI / ANSI / ISO 10993-5:2009/(R) 2014, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.

ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and

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Image /page/10/Picture/0 description: The image contains the logo for ClaroNav. The logo consists of a black and white graphic on the left and the word "ClaroNav" on the right. The graphic is a black and white circle divided into quadrants, with each quadrant containing a different pattern. The word "ClaroNav" is written in a bold, sans-serif font.

essential performance (IEC 60601-1:2005, mod)

IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.

IEC 62471 First edition 2006-07, photobiological safety of lamps and lamp systems. (Radiology)

FDA Guidance Document Applying Human Factors and Usability Engineering to Optimize Medical Device Design, June 22, 2011

SUMMARY OF PERFORMANCE TESTING

Performance testing of the Navident system was conducted in accordance with all the above referenced standards and regulations. All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those of the predicate device.

Navident's performance testing included:

1. Sterilization Validation: A representative sample of the re-usable Navident components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable Navident components can be sterilized to reach an acceptable sterility assurance level.
1. Biocompatibility Testing: The patient-contacting Navident components were tested according to the ISO 10993-1 series as follows:
- . Navident components were tested using the MEM Elution test method to assess cytotoxic effects. as per ISO 10993-5 biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. All test method acceptance criteria were met, supporting the conclusion that the Navident component is biocompatible and appropriate for its intended use.
- . Navident components were tested for hypersensitivity reactions following the Maximization Sensitization Test Method which meets the criteria of ISO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of reaction or sensitization of the Navident test article on the test subjects was observed and all acceptance criteria were met.
- . Irritation testing of Navident components was completed following the Oral Mucosal Irritation Study which meets the criteria of SO 10993-10:2010 Biological Evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization. No evidence of irritation to the test subject's oral mucous membranes was observed and all acceptance criteria were met.

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Image /page/11/Picture/0 description: The image shows the logo for ClaroNav. The logo consists of a black and white geometric design on the left, resembling a stylized compass or radar. To the right of the design is the text "ClaroNav" in a bold, sans-serif font. The text is positioned above a solid black bar, creating a contrasting visual element.

1. Full system bench testing was conducted on the Navigation system. The bench tests evaluated the following operational aspects:
- a. Overall accuracy of the system in mapping the drill tip to the CT image;
- Repeatability of the handpiece calibration process; ﻗ
- C. Effect of different image voxel sizes on the mapping accuracy;
- d. Effect of distance between the tracking camera and the JawTag on mapping accuracy;
- e. Effect of the number of available fiducial corners on mapping accuracy;
- f. Effect of different ambient lighting conditions on mapping accuracy;
- Effect of camera warmup time on mapping accuracy; g.
- Effectiveness of the NaviStent fabrication process with a number of random jaw models; h.
- i. Evaluating possibility of getting the NaviStent locked onto the teeth;
- j. Repeatability of interlocking of CT Marker with Retainer during CT scan;
- Impact of autoclaving cycles on Silicon tape strength; k.
- l. Tag adapter sterilization tolerance;
- m. Effect of ambient temperature on accuracy;
- n. Effect of strong light shining on one of the tags (HDR mode);

The bench tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. Additionally, the system passed all tests of immunity to electromagnetic interference according to IEC 60601-1-2 while providing accurate drilling guidance.

1. Human factors/usability summative evaluation was conducted on the Navident system under controlled simulated setting. 15 representative users (i.e., oral surgeons, general dental practitioners) were observed performing representative and high-risk tasks with the Navident system while test administrators monitored the proceedings for any use errors, close calls, operational difficulties that may be indicative of use-safety or usability problems. The assessment of the test results demonstrated that the Navident system satisfies user specifications for use by qualified dentists for its intended use. .
1. ClaroNav has collected and compiled clinical, usability and accuracy data related to the application of Navident in clinical practice by a diverse international group of surgeons. The clinical case data collected consisted of 21 cases with 36 guided implantations. In all cases, Navident fully performed its intended function without complications. Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex. The clinical evaluation further consisted of collecting systematic feedback on usage history and professional impressions from 7 surgeons who treated a total 150 patients guided by Navident. No significant patient adverse events or complications were reported by any participating surgeon.

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Image /page/12/Picture/0 description: The image shows the logo for ClaroNav. The logo consists of a black and white graphic on the left and the word "ClaroNav" in black text on the right. The graphic is a circular design with alternating black and white quadrants. Below the text and graphic is a solid black bar.

CONCLUSION

Navident is substantially equivalent to its predicate in its indications for use, principles of operation, technical characteristics, performance and usability as demonstrated using a comprehensive comparison of all relevant characteristics, and by thoroughly testing all key aspects of Navident's performance.

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.