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 partially or fully edentulous jaws.

Device Description

Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image. Navident is comprised of the following parts: The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software. The Navident system also includes several types of accessories: Jaw motion Tracking Accessories, Dental Handpiece Tracking Accessories, Registration accessories, Calibrator. Navident's four core functions are: Model, Plan, Register, Guide.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

Device: Navident

Product Code: PLV
Regulation Number: 21 CFR 872.4120
Regulation Name: Bone Cutting Instrument And Accessories
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the performance data of the device rather than explicit "acceptance criteria" presented as pass/fail thresholds against specific metrics, except for the accuracy at the drill tip. Instead, it describes various validation and testing activities that collectively demonstrate the device's acceptable performance.

Category	Acceptance Criteria / Standard (Implicit or Explicit)	Reported Device Performance / Study Finding
Reprocessing	Per AAMI TIR 30: 2011(R) 2016 for cleaning (Proteins < 6.4 µg/cm2, Hemoglobin < 2.2 µg/cm2). Per ISO 17665-1:2006 (R) 2013 for sterilization (acceptable sterility assurance level).	Cleaning: Validation demonstrated that the cleaning process included in Navident's labeling can reduce the organic soil load to an acceptable level (meeting the specified protein and hemoglobin thresholds). Sterilization: Validation confirmed components withstand steam sterilization and achieve acceptable sterility using recommended protocols.
Biocompatibility	Per ISO 10993-1 series or justified non-performance.	Patient-contacting components considered tissue contacting for < 24 hours. Tested per ISO 10993-1 or justification provided per FDA Guidance.
Software	Per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern).	Software documentation submitted according to the guidance.
Electrical Safety	Per IEC 60601-1:2005 Edition 3.1 & ANSI/AAMI ES60601-1:2005 / 2012 & C1:2009/ 2012 & A2:2010/ 2012.	Compliance with these standards for product safety.
Electromagnetic Compatibility (EMC)	Per IEC 60601-1-2:2014 Edition 4.0.	Compliance with this standard for EMC.
Wireless Technology	Per FDA Guidance "Radio Frequency Wireless Technology in Medical Devices".	Evaluation assessment conducted.
System Accuracy Test (Bench)	Explicit: Accuracy at the drill tip ≤1.0mm. Stability and repeatability of patient reference tag coupling to jaw.	In all instances (System accuracy test, stability of Jaw Tracker S, C, B, U attachments), the Navident device functioned as intended and the results observed were as expected. The "Accuracy at the drill tip" is explicitly stated as "≤1.0mm" for the proposed Navident, matching the predicate device. Observed performance of new Trace Registration Method: Mean deviation for 136 implants: 0.67 mm (entry), 0.9 mm (apex), 0.55 mm (depth), 2.50° (angular). These values are all below the 1.0mm limit for positional accuracy and represent successful performance for the angular deviation.
Human Factors/Usability	Meet identified user specifications; no significant use errors, close calls, or operational difficulties.	Summative evaluation demonstrated that the Navident system satisfies identified user specifications. Minor findings were thoroughly analyzed and design improvements made.
Clinical Literature (Trace Registration Method)	Demonstrate acceptable accuracy for the new registration method, comparable to or better than existing methods.	Study 1: 136 implants in 59 partially edentulous patients. Mean deviation: 0.67 mm (entry point), 0.9 mm (apex), 0.55 mm (depth), 2.50° (angular deviation). 95th percentile values for trace registration (5-6 teeth) were favorable compared to fiducial marker-based registration (predicate device's method). Study 2: (Pterygoid implants) 31 dynamic navigation cases vs. 32 freehand surgery cases. Mean deviations for dynamic navigation via trace registration: 0.66 mm (coronal), 1.13 mm (apical), 0.67 mm (depth), 2.64° (angular). This was more accurate than freehand surgery.

2. Sample Sizes and Data Provenance

Test Set (Clinical Data from Literature):
- Study 1 (Trace Registration Accuracy): 136 implants placed in 59 partially edentulous patients.
- Study 2 (Pterygoid Implants): 63 pterygoid implants in 39 partially edentulous patients (31 with dynamic navigation/trace registration, 32 with freehand surgery).
Data Provenance: Clinical studies were conducted outside of the US. The document states that "patient populations, user profiles, use environment, and clinical practices are considered equivalent and applicable to the US population." The studies are retrospective, as they are "published scientific literature" that was collected and analyzed.
Human Factors/Usability Study: 15 representative users.
Bench Testing: Sample sizes are not explicitly stated for individual bench tests (reprocessing, electrical safety, EMC, full system accuracy bench testing, stability/repeatability of attachments), but it mentions "representative devices" and "representative master devices."

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

The clinical studies referenced are "published scientific literature" and involve "qualified dental surgeon(s)" performing the procedures. The ground truth for the clinical accuracy studies (Study 1 & 2) appears to be derived from actual implant placement compared to the pre-planned position (likely measured from post-operative imaging).

Number of Experts: Not explicitly stated as "number of experts for ground truth establishment." The studies were performed by treating surgeons. Study 2 mentions "the same surgeon" for comparative data, implying single-surgeon data collection for parts of the comparison.
Qualifications of Experts: "Qualified dental surgeon(s)." One of the authors in the referenced papers (Stefanelli LV, Mandelaris GA) are typically oral and maxillofacial surgeons or periodontists who are experts in implant surgery.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is described for the ground truth of the clinical studies. The accuracy metrics appear to be derived from quantitative measurements comparing planned vs. actual outcomes, likely without a separate expert adjudication panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not explicitly performed in the context of comparing human readers with and without AI assistance, as Navident is a surgical navigation system, not an AI-assisted diagnostic imaging device for human reading. The "comparison" is between different surgical techniques (dynamic navigation with trace registration vs. freehand surgery, or dynamic navigation with new trace registration vs. old fiducial registration) or system accuracy benchmarks, not human interpretation of images. However, the studies demonstrate the clinical effectiveness of the device-assisted procedure.

Effect Size for AI vs. Without AI Assistance:
- Study 1 (Trace Registration vs. Fiducial-based): The 95th percentile values for the trace registration method were "favorable" compared to the fiducial-based registration method (cleared predicate). This implies an improvement, but specific effect sizes are not quantified here beyond the descriptive "favorable." This is a comparison of system performance, not human performance.
- Study 2 (Dynamic Navigation with Trace Registration vs. Freehand Surgery): Dynamic navigation was "more accurate." The mean deviations for dynamic navigation were significantly lower across all metrics (e.g., 0.66 mm coronal vs. 1.54 mm for freehand; 2.64° angular vs. 12.49° for freehand). This provides a clear quantitative effect size for the improvement in surgical accuracy when using the device compared to freehand.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The "Full system accuracy bench testing" and the clinical accuracy studies (comparing planned vs. actual implant positions) inherently represent the performance of the algorithm and system, as they quantify the accuracy of the guidance provided by the device. While a human surgeon provides the input and executes the drilling, the accuracy metrics are a direct measure of the system's ability to guide to the planned position. The "Accuracy at the drill tip: ≤1.0mm" is a standalone performance metric.

7. Type of Ground Truth Used

Clinical Studies: Ground truth for implant accuracy was based on comparison of the pre-planned position (from CT scan) with the actual post-operative implant position (derived from post-operative imaging). This is a form of outcomes data or objective measurement of surgical execution.
Bench Testing: Ground truth for system accuracy was established through controlled measurements conducted on test setups designed to measure the mapping accuracy and stability.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. This is a surgical navigation system, not typically a machine learning or AI model trained on a large imaging dataset in the conventional sense. The "training" for the device's development would be more akin to algorithm development and calibration rather than data-driven machine learning, although some components might use statistical models or optimizations. The clinical literature cited pertains to validation of the device's performance, not training data for an AI.

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

Given that a specific "training set" for an AI algorithm is not mentioned, the method for establishing its ground truth is also not described. The device's core functionality relies on stereoscopic optical tracking and registration algorithms, whose "ground truth" and performance are verified through precise engineering and bench testing rather than large-scale data labelling for AI training.

Summary

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ClaroNav Inc. Carly Desmond Director of Regulatory Affairs 1140 Sheppard Avenue West Unit 10 Toronto, Ontario M3K 2A2 CANADA

Re: K210947

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: June 2, 2022 Received: June 2, 2022

Dear Carly Desmond:

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) K210947

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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510(k) SUMMARY K210947 ClaroNav's Navident

Sponsor:	ClaroNav Inc.1140 Sheppard Avenue West, Unit 10Toronto, Ontario, M3K 2A2Canada
Contact Person	Doron Dekel
Phonee-mail	+1 647 868 6813doron@claronav.com
Submission Date	June 24, 2022
Device Proprietary Name	Navident
Common Name	Surgical Navigation System
Classification	PLV
Class	II
RegulationClassification Panel	21 CFR 872.4120; Bone Cutting Instrument and AccessoriesDental

Predicate Devices

Primary predicate: ClaroNav's Navident (K161406)

Reference device: X-Nav's X-Guide (K200662)

Indications for Use

Technological Characteristics

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the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image.

Navident is comprised of the following parts:

The main system is comprised of a cart that carries a stereoscopic video camera and a laptop . with pre-installed proprietary software.
. The Navident system also includes several types of accessories:
- Jaw motion Tracking Accessories: Accessories that are rigidly attached to the O patient's jaw and are used to maintain the registration between the jaw and its CT image throughout the procedure via real-time tracking of the jaw. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the patient's Jaw (for tracking the upper jaw only).
- Dental Handpiece Tracking Accessories: Accessories that are rigidly attached to a O dental handpiece to be navigated during the dental procedure. They comprise a tag with optical markings trackable by the stereoscopic video camera and a mechanism for rigid attachment of the tag to the handpiece.
- Registration accessories: Accessories that are used in the registration of the patients' O anatomy with the patients' CT scan.
- Calibrator: A tool used for calibrating the working tip of the handpiece to determine O the geometric relationship between the optical marking on the handpiece-attached tag and the working tip of the surgical instrument.
Navident's four core functions are: ●
- Model: Using data imported from CT and intraoral surface scanners, a digital model of O the jaw anatomy is compiled and presented to the user.
- Plan: The user, using functions provided by the Navident application software, O prepares a digital treatment plan for drilling in bone.
- Register: At the start of the actual treatment, the digital model is aligned with the real O anatomy it models. The plan, which was created in geometrical reference to the model can now be referenced, or mapped, to the real anatomy.
- Guide: The tooltip (the working end) of the treatment tool, usually a handpiece with O an exchangeable tip, is dynamically shown to the user relative to the (registered) model and the treatment plan.

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The user uses the on-screen quidance to align the tooltip with the planned tooltip path to ensure correct and accurate execution of the plan. During surgery, Navident automatically tracks the handpiece's motions. When the handpiece 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 quides the hand motions of the surgeon towards precisely locating the planned entry point, adjusting the drill axis to the planned angle, and drilling to the planned depth. When the tip is away from a marked implantation path, Navident provides real-time visual feedback showing the CT image intensities in the region surrounding the drill's tip.

The Navident is intended for the drilling of osteotomies for dental implant placement with high-speed and low-speed dental handpieces This submission focuses on modification of the Navident predicate device (K161406) to include additional components including the wireless connection, use of bone screws for edentulous patients, additional patient tracker designs, and a tracing method for registration.

Performance Data

Navident's performance testing included:

Reprocessing validation: .
- . Manual and automated cleaning validation: manual and automated cleaning validation was performed on representative devices to confirm that the cleaning processes of Navident's accessories can reduce the organic soil load, per AAMI TIR 30: 2011(R) 2016, to:
  - o Proteins : < 6.4 µg/cm2
  - O Hemoglobin :< 2.2 µg/cm2

The validation demonstrated that the cleaning process included in Navident's labeling can reduce the soil load to an acceptable level.

. Sterilization Validation: Representative master devices of the re-usable Navident accessories 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 (R) 2013 and it validated that the re-usable Navident components can be sterilized to reach an acceptable sterility assurance level.

. Biocompatibility Testing:

The patient contacting Navident components are considered tissue contacting for a duration of less than 24 hours. The components were either tested according to the ISO 10993-1 series or a justification for not performing tests was provided per the 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."

. Software:

Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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. Electrical Safety and Electromagnetic Compatibility (EMC):

Comprehensive performance testing has been conducted on the Navident device in accordance with the latest recoqnized industry standards, by an accredited NRTL. Product Safety was evaluated for compliance with IEC 60601- 1:2005 Edition 3.1 ANSI/AAMI ES60601-1:2005 / 2012 and C1:2009/ 2012 and A2:2010/ 2012 (Consolidated Text) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance. Electromagnetic Compatibility was assessed for compliance with IEC 60601-1-2:2014 Edition 4.0.

Evaluation assessment of the wireless technology was conducted per FDA Guidance "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff."

. Full system accuracy bench testing:

The navigation information provided to the user is based on the mapping of the drill tip pose to the CT image data. The accuracy of this mapping is determined by two key factors: (1) the accumulation of errors through the sequence of real time coordinate system mappings and (2) the stability of the coupling between the patient's reference tag and the patient's anatomy. Accordinqly, to assess the overall system accuracy, the following bench tests were performed:

System accuracy test: to measure the accuracy of the mapping between drill tip poses . and image space.
. Assess the stability and repeatability of the patient reference tag coupling to the patient's jaw:
- Stability of the Attachment of the Jaw Tracker S to the patient's Jaw ■
- Stability of the Attachment of the Jaw Tracker C to the patient's Jaw
- I Stability of the Attachment of the Jaw Tracker B to the patient's Jaw
- Stability of the Attachment of the Jaw Tracker U to the patient's Jaw I

In all instances, the Navident device functioned as intended and the results observed was as expected.

Human factors/usability: .

Summative evaluation was conducted on the Navident system within a realistically simulated clinical setting. Fifteen (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 or operational difficulties that may be indicative of use-safety or usability problems. The assessment of the test results demonstrated that the Navident system satisfies the identified user specifications for use by qualified dentists for its intended use. Minor findings of the evaluation were thoroughly analyzed and design improvements to Navident were made to address them prior to the current submission.

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Clinical Literature: .

Clinical evidence supporting the performance of the device was collected from published scientific literature. The described studies were conducted outside of the US; however, the patient populations, user profiles, use environment, and clinical practices are considered equivalent and applicable to the US population.

Three studies were identified which support the substantial equivalence of the Trace registration method. The first study | reports on the accuracy results of 136 implants placed under dynamic guidance using the trace registration method in 59 partially edentulous patients. Thirty-nine (39) cases involved the maxilla (75 implants) and 36 cases involved the mandible (61 implants). The mean deviation between the planned and actual position for all implants was 0.67 mm at the entry point, 0.9 mm the apex, 0.55 mm in depth and 2.50° as angular deviation. Tracing 5-6 teeth for registration significantly improved all accuracy outcomes compared to tracing only 3-4 teeth. The 95th percentile values were also computed for the present trace registration method and compared with corresponding measurements taken in an earlier study2 using a thermoplastic stent and fiducial marker-based registration (the registration method that was cleared for the predicate Navident device K161406). This data was previously collected and published by the same authors and the same surgeon using the stent approach with the same navigation system. The results demonstrated that using trace registration was favorable compared to fiducial-based registration especially when tracing 5-6 teeth.

In another study Stefanelli et al. compared the accuracy of Pterygoid implant placement using dynamic navigation with trace registration versus free hand surgery. In this study 63 pterygoid implants were placed in 39 partially edentulous patients. Thirty-one (31) pterygoid implants were placed using dynamic navigation and trace registration and 32 pterygoid implants were placed using freehand surgery. The mean deviations between the planned and actual position for pterygoid implants placed using dynamic navigation via trace registration was 0.66 mm at coronal level, 1.13 mm at apical level, 0.67 mm in depth, and 2.64° as angular deviation compared to 1.54mm, 2.73mm, 1.17mm and 12.49°, respectively, when freehand surgery alone was used. Pteryqoid implants placed using dynamic navigation technology was more accurate when compared to the prosthetically directed presurgical plan in relation to the greater palatine canal and took less surgical time.

In conclusion, one of the main changes introduced by the Navident device in comparison to the predicate Navident device is the addition of another registration method (Trace) on top of the previously available stent and fiducial reqistration. The accuracy of this registration method was evaluated on 136 implants and was found to be as accurate as fiducial base registration. In addition, the trace registration method was used with 31 Pterygoid implants while comparing to free hand surgery. The results were in favor of the use of dynamic navigation with trace registration.

References:

1. Stefanelli LV, Mandelaris GA, DeGroot BS, Gambarini G, De Angelis F, Di Carlo S. Accuracy of a Novel Trace-Registration Method for Dynamic Navigation Surgery. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):427-435.
1. Stefanelli LV, DeGroot BS, Lipton Dl, Mandelaris GA. Accuracy of a Dynamic Dental Implant Navigation System in a Private Practice. Int J Oral Maxillofac Implants. 2019 January/February;34(1):205–213.

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1. Stefanelli LV, Graziani U, Pranno N, Di Carlo S, Mandelaris GA. Accuracy of Dynamic Navigation Surgery in the Placement of Pterygoid Implants. Int J Periodontics Restorative Dent. 2020 Nov/Dec;40(6):825-834.

Substantial Equivalence

The current Navident is substantially equivalent to the cleared Navident (K161406). Navident has similar intended use, technological characteristics, and principles of operation as its predicate device. The technological differences between the Navident and its predicate devices raise no new issues of substantial equivalence and its substantial equivalence is further supported by a comparison to a reference device that offers the same intended use and very similar technological characteristics. Performance data demonstrate that Navident is substantially equivalent to the cleared Navident. A comparison of the proposed Navident device to the currently marketed predicate Navident and the reference X-Nav's X-Guide are provided in Table 5-1 below:

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Table 5-1: Comparison of Indications for use and Technological Characteristics

Feature/Characteristic	Proposed Navident	ClaroNav's Navident K161406(Predicate device)	X-Nav's X-guide deviceK200662(Reference Device)	Justification of difference
Intended Use
Class/ProductCode/ClassificationName	Class II/ PLV/21 CFR 872.4120(Bone Cutting Instrument andAccessories)	Class II/ PLV/ 21 CFR 872.4120(Bone Cutting Instrument andAccessories)	Class II/ PLV/ 21 CFR 872.4120(Bone Cutting Instrument andAccessories)	Identical
Indications for Use	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 partially or fullyedentulous jaws.	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.	The X-Guide® SurgicalNavigation System is acomputerized navigationalsystem intended to provideassistance in both thepreoperative planning phaseand intra-operative surgicalphase of dental implantationprocedures. The system providessoftware to preoperatively plandental implantation proceduresand provides navigationalguidance of the surgicalinstruments.The device is intended for usefor partially edentulous andedentulous adult and geriatricpatients who need dentalimplants as part of theirtreatment plan.	Navident has the same intended use as thepredicate device.Navident expands the cleared indication foruse of the predicate device from partiallyedentulous patients to partially edentulousand edentulous patients. Hardwarecomponents (Jaw Tracker B) and alternativeregistration method (Bone screws) are offeredin the Navident to support edentulouspatients.The reference device, which is also a dentalnavigation system that uses similartechnology, offers similar technologicalsolutions for edentulous patients and hasidentical intended use and indications for useas the Navident.
Main functions	CT-based placement planning ofdental procedures. Presentationof position, angle and depthindicators when drilling in orcutting the jaw.	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.	Identical
Use Environment	Dental clinic	Dental clinic	Dental clinic	Identical
Target Population	Adult patients	Adult patients	Adult patients	Identical
Users	Dental surgeons	Dental surgeons	Dental surgeons	Identical
Technological Characteristics
Input imaging modality	CT	CT	CT	Identical
Dynamic object posesmeasurementtechnology	Stereoscopic triangulation ofchecker-board contrast patterns.	Stereoscopic triangulation ofchecker-board contrast patterns.	Stereoscopic triangulation ofchecker-board contrast patterns.	Identical
Handpiece trackingattachment	a visually marked tag.	a visually marked tag.	a visually marked tag.	Identical
Jaw trackingattachment(Dentate Patients)	"NaviStent" : molded thermoplastic sheet with an integrated arm holding an optically marked plastic tag. OR: "Jaw Tracker" : optically marked flat tag attached to a hand-configurable stainless steel wire attached to the jaw at its other end. The JawTracker C and S version attaches to a tooth, crown or abutment using approved dental composite resin and bonding agent. The JawTracker U version attaches to several adjacent teeth using a U-shaped clamp filled with bite registration material.	"NaviStent" molded thermoplastic sheet with an integrated arm holding an optically marked plastic tag. No support for edentulous jaws.	X-Clip®, is attached to patient teeth using an impression material (low temperature thermoplastic). The Patient Tracker which includes the tracking patterns that is visualized by the tracking camara is firmly attached to the X-Clip. This device remains on the patient teeth for the duration of surgery.	Navident offers an identical solution for Jaw tracking (the NaviStent) as the cleared Navident device. In addition, two alternative jaw attachment solutions are offered (JawTracker C and JawTracker U). While the materials used for the attachment (thermoplastic, PVS, composite) and their hardening methods (cooling, chemical or light curing) vary, they are all moldable dental materials in common usage, with well-known properties.
Jaw TrackingAttachment(Edentulous Patient)	JawTracker B: optically markedflat tag attached to a hand-configurable stainless steel wireattached to the jaw bone using 3small bone screws.	None	Edentulous Clip® - fixated intoposition on the patient's jawusing bone screws. The patienttracker, which includes thetracking patterns that isvisualized by the trackingcamera is firmly attached to theEdentulous Clip. This deviceremains on the patient teeth forthe duration of surgery.	Navident's Jaw Tracker B solution is verysimilar to the Edentulous clip of the referenceX-Guide device, and is based on an opticallymarked tag that is attached to the patients Jawusing a small plate that is fixated into positionon the patient's jaw using bone screws.
Patient to CT imageregistration	NaviStent: includes aremovable CT Marker partcontaining a CT-visiblefiducial body. Trace Registration:registration based onAnatomical Landmarks onthe jaw's surface.. Bone screws: placed in thepatient's Jaw prior to CTscan to create fiducials. NaviBite: plastic appliancecontaining several screwswith their heads exposed.Used with impressionmaterial to form a biteregistration plate that canbe repeatably coupled toboth jaws.	NaviStent: includes a removableCT Marker part containing a CT-visible fiducial body.	X-Clip: contains embeddedradiodense spheres used asfiducial. Bone hole Fiducials: Foredentulous patients, thesurgeon drills several narrowholes in the bone to serve asfiducials for the CT scan. X-Mark: registration basedon Anatomical Landmarks. Bone screws: placed in thepatient's Jaw prior to CTscan to create artificiallandmarks.	Navident's registration solutions are identicalor very similar to the ones offered in thepredicate and the reference devices: The Navistent is a fiducial basedregistration, identical to Navident's clearedregistration solution (K161406). The "Trace Registration" is very similar toX-Guide X-mark registration solution. Bothare based on existing anatomicallandmarks as fiducials. These landmarksare manually marked in the Software andare traced by touching them with the tipof an optically trackable tracer tool. Bone Screw: same as offered by X-Guidereference device, the bone screws areplaced in the patient's Jaw prior to CT scanto create artificial landmarks. NaviBite: The screw heads, anchored tothe NaviBite plastic shell, function verysimilarly to the spheres embedded in theX-Clip solution of X-Guide. In theregistration process, both are touched bya special pointer to provide their location

Drill tip calibration	Initial drill axis calibration on a tracked pin, plus tip calibration by placing the tip in a dimple in a special optically marked tool (Calibrator) after each drill change. Support for both low speed and high-speed handpieces	Initial drill axis calibration on a tracked pin, plus tip calibration by placing the tip in a dimple in the Jaw Tag after each drill change.	Initial handpiece calibration using a special optically marked tool, plus tip calibration by touching a point after each drill change.	relative to the optical markings on the tag coupled to the jaw.The calibration steps are similar. In the cleared Navident device, the jaw tag was used to also perform these calibration steps, eliminating the need for a separate tool. The Navident, offers a dedicated calibration tool, same as the reference device (X-Guide).
Mount for camera and display	Mobile cart weighing 55lb with a folding arm holding camera and screen above patient's chest.	Mobile cart weighing 55lb with a folding arm holding camera and screen above patient's chest.	Mobile cart with a large arm holding camera above patient's head. Screen is attached to cart pole.	Identical to the cleared Navident device
Presentation of navigation guidance	3D graphics presentation of drill position, angle and depth relative to planned placement.	3D graphics presentation of drill position, angle and depth relative to planned placement.	3D graphics presentation of drill position, angle and depth relative to planned placement.	Identical to the cleared Navident device
Illumination of tracking targets	Visible light emitted by LED panel (optional)	Visible light emitted by LED panel (optional)	Visible light emitted by LED panel (optional)	Identical to the cleared Navident device
Performance Characteristics
Accuracy at the drill tip	≤1.0mm	≤1.0mm		Identical to the cleared Navident device
Presentation update rate	Real time	Real time		Identical to the cleared Navident device

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ClaroNav's Navident

SECTION 5 510(k) Summary

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SECTION 5 510(k) Summary

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ClaroNav's Navident

SECTION 5 510(k) Summary

Doc #: 985-09011 Page: 5- 9 of 9

Conclusions

The Navident has been shown through technical comparison to be substantially equivalent to the identified predicate and referenced devices when used as intended.

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.