X-Guide Surgical Navigation System

K232148 · X-Nav Technologies, LLC · QRY · Feb 21, 2024 · Dental

Device Facts

• Record ID: K232148
• Device Name: X-Guide Surgical Navigation System
• Applicant: X-Nav Technologies, LLC
• Product Code: QRY · Dental
• Decision Date: Feb 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.

Device Story

X-Guide Surgical Navigation System is a cart-mounted, video-based navigation system for dental surgery. It tracks the position/movement of a dental handpiece relative to patient anatomy using stereo cameras and LED-illuminated tracking patterns. The system integrates preoperative planning (using CT/CBCT data) with intra-operative guidance. The surgeon uses an LCD monitor for real-time visual feedback, showing the handpiece location relative to the surgical plan. The system provides 6-degree-of-freedom tracking with <1mm RMS accuracy. The subject device adds 'IconiX' Automatic Image Processing (AIP), a machine learning module that segments anatomical structures (teeth, bone, sinuses, mandibular nerve canal) from CT and IOS data to assist in planning, panoramic curve generation, and IOS-to-CT registration. The system remains a supporting tool; the surgeon retains control and final decision-making authority. It is used in clinical settings by dentists.

Clinical Evidence

No clinical studies were performed. Evidence consists of software verification and validation testing, including validation of machine learning outputs for anatomical segmentation and verification of integrated system functions (pan curve generation, IOS-to-CT registration, and SurfiX generation).

Technological Characteristics

Mobile cart-mounted system; stereo cameras with blue LED illumination; LCD-TFT monitor; Ethernet connectivity. Software includes navigational guidance and ML-based AIP for segmentation. Biocompatible materials (ISO 10993). Sterilization via steam; high-level disinfection with 3% glutaraldehyde. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Accuracy <1mm RMS. ML algorithm is non-adaptive/locked.

Indications for Use

Indicated for partially edentulous and edentulous adult and geriatric patients requiring dental implants or endodontic access procedures (apicoectomies, calcified canal access) where CBCT is appropriate.

Regulatory Classification

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.

Predicate Devices

• X-Guide® Surgical Navigation System (K211701)

Reference Devices

• DTX Studio Clinic 3.0 (K213562)
• NobelClinician®, DTX Studio Implant (K163122)

Submission Summary (Full Text)

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February 21, 2024

X-Nav Technologies, LLC Kimberly Chan Director of Regulatory Affairs and Quality Assurance 1555 Bustard Road Suite 75 Lansdale, Pennsylvania 19446

Re: K232148

Trade/Device Name: X-Guide Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: QRY, PLV Dated: January 24th, 2024 Received: January 24th, 2024

Dear Kimberly Chan:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

Submission Number (if known)

K232148

Device Name

X-Guide Surgical Navigation System

Indications for Use (Describe)

The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures.

The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.

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/4/Picture/0 description: The image shows the logo for X-NAV Technologies. The "X" in X-NAV is stylized with green, blue, and gray horizontal lines. The rest of the text, "-NAV TECHNOLOGIES" is in a dark blue color, except for the word "TECHNOLOGIES" which is in light gray.

# 510(k) Summary - K232148

(As required by Section 807.92(c))

| Date Prepared:<br>Applicant: | 21 FEB 2024<br>X-Nav Technologies, LLC<br>1555 Bustard Road, Suite 75<br>Lansdale, PA. 19446 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kimberly Chan<br>Director of Regulatory Affairs and Quality Assurance<br>Phone: [phone]<br>[e-mail] |
| Device Trade / Proprietary Name: | X-Guide Surgical Navigation System<br>Model P007839<br>Model P011000 |
| Device Name, Common/Usual: | Surgical Navigation System |
| Classification Name:<br>Regulatory Class:<br>Product Code: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories)<br>II<br>QRY, PLV |
| Predicate Device:<br>Reference Devices: | X-Guide® Surgical Navigation System (K211701)<br>DTX Studio Clinic 3.0 (K213562)<br>NobelClinician®, DTX Studio Implant (K163122) |

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Image /page/5/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal lines in green, dark blue, and gray. To the right of the "X" is the text "-NAV" in dark blue. Below the "X" and "-NAV" is the text "TECHNOLOGIES" in gray.

# Proposed Change – Automatic Image Processing (AIP) Software Integration (IconiX)

The proposed change is a software change to integrate a machine learning software trained on varied CT data to segment and identify anatomical structures in a maxillofacial Computer Tomography (CT) scan and in an IntraOral Scan (IOS). The machine learning software performs Automatic Image Processing when a CT or IOS is loaded into the X-Guide System. The software is not adaptive. Rather, it is trained at the manufacturer and the weights are locked.

The AIP initializes upon opening a patient case. The original CT is not altered. All data is displayed is superimposed on the radiographic images, allowing for users to view and confirm the correctness and completeness of results and, if desired, replace or augment them with conventional tools/methods provided in the predicate device.

The machine learning software can recognize the following anatomical features in a CT:

- Teeth (including roots) -
- Maxilla bone -
- -Mandible bone
- Maxillary Sinuses -
- Mandibular Nerve Canal -

The machine learning software can recognize the following anatomical features in an IOS:

- Teeth -
- -Gingiva

Additionally, the software may also use the Automatic Image Processing outputs to:

- create a pan curve automatically to fit the arch (minimum of two teeth per sextant required) -
- register (superimpose) the IOS over the CT -
- generate the X-Guide SurfiX from the segmented teeth and bone for use in X-Mark Registration (point marking) or Refinement.

The subject device is the same as the X-Guide® Surgical Navigation System cleared under K211701 (the predicate device) except for the addition of the machine learning software. There are no changes to the components. There are no changes to the calibration workflow or navigation process.

The differences in software do not affect the safety or effectiveness of the device when used as labeled. The device is still for use with dental surgical procedures under the control of a trained surgeon. The X-Guide® Surgical Navigation System is a supporting device, providing additional information to the decision-making process during the surgical procedure. It is by no means intended to replace the surgeon's judgment. The final decisions as to the exact location and depth of the surgery are the sole responsibility of the surgeon can at any time during the surgical procedure modify the planned trajectories. Under no circumstances does the device the surgeon of his or her ultimate clinical responsibility.

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Image /page/6/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of green, blue, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a dark blue, sans-serif font. Below the "X-NAV" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font.

# Device Overview

The X-Guide® Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Hand-Piece) during surgical procedures.

The X-Guide® Surgical Navigation System consists of a Mobile Cart, equipped with an LCD Monitor, Boom Arm, Navigation Assembly, Keyboard, Mouse and an Electronics Enclosure. Reference Figures 1 and 2 for an illustration.

The Electronics Enclosure contains the system power supplies, data processing hardware, and electronics control circuitry for coordinating operation of the X-Guide® Surgical Navigation System.

A LCD Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Go-Button serves as an additional form of input by providing virtual buttons that a user can activate by touching them with the surgical instrument tip.

The Boom Arm allows the operator to manipulate the Navigation Assembly position for optimal distance and alignment to patterns located with the surgical region (Navi-Zone) for tracking purposes. The Boom Arm can be extended up to ~79" in the X-Axis and retracts to ~35". It can be positioned 180 degrees in the left to right to left motion range.

The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting for illuminating the patterns and mitigating ambient lighting noise.

This electro-optical device is designed to improve dental surgical procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data.

The surgical process occurs in two stages. Stage 1 is the pre-planning of the surgical procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant or endodontic trajectory is aligned and oriented to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during surgery. Once an implant or trajectory has been optimally positioned, the plan is transferred to the X-Guide Surgical Navigation System in preparation for surgery.

In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the preoperative plan.

As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Handpiece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient.

The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and depicted in precise location and orientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the

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Image /page/7/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray horizontal bars. To the right of the "X" is the word "NAV" in large, bold, blue letters, and below the "X-NAV" is the word "TECHNOLOGIES" in smaller, gray letters.

surgical plan. This provides continuous visual feedback that enables the dental surgeon to manewer the dental handpiece into precise alignment.

During execution of the surgical procedure, the X-Guide® Surgical Navigation System correlates between the surgical plan and the surgeon's actual performance. If significant deviations in navigation between the plan and the system performance occur, the system will alert the user.

Safety glasses are provided for patient use on an optional as needed basis.

Device accuracy has been evaluated for compliance with FDA recognized performance standard ASTM F2554- 18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.

Image /page/7/Picture/5 description: The image shows a medical device with several labeled components. The device includes a boom arm, a navigation assembly, LEDs and cameras, a monitor, and an electronics enclosure. The boom arm is connected to the navigation assembly, which houses the LEDs and cameras. The monitor is mounted on a stand, and the electronics enclosure is located at the base of the device.

Figure 1: X-Guide® Surgical Navigation System (P007839)

Image /page/7/Figure/7 description: The image shows a medical device with several labeled components. The device includes a boom arm, a navigation assembly with LEDs and cameras, and a monitor. The device also has an electronics enclosure at the base, which is mounted on wheels.

Figure 2: X-Guide® Surgical Navigation System (P011000)

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Image /page/8/Picture/0 description: The image is a logo for X-NAV Technologies. The logo has the letters X-NAV in a bold, sans-serif font. The X is made up of green, blue, and gray shapes. The word "TECHNOLOGIES" is written in a smaller, sans-serif font below the letters X-NAV.

# Device Description

The benefit is to improve surgical procedures and reduce risk of potential damage to adjacent anatomical structures and tissues, resulting in a reduction of risk to the patient.

The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of < 1 mm. This helps to improve the surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery.

Several patient-specific calibrations underpin the guidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument.

## Patient Tracker Calibration

Patient Tracker calibration is performed to determine the geometric relationship between the Patient Tracker and the scan coordinates of the patient anatomy. There are separate procedures for Patient Tracker calibration, depending on whether the patient is edentulous, partially edentulous, or if the surgeon wishes to use the X-Mark process.

- X-Clip Calibration: For toothed patients (partially edentulous), an X-Clip®, which contains ● embedded radiodense spheres, is attached to patient teeth prior to CT image acquisition. The location of these spheres on the X-Clip establishes a link between the CT coordinate system and the patient's surgical anatomy. Immediately prior to surgery, the Patient Tracker is attached, and a separate calibration determines the relationship between the spheres and the Patient Tracker. This device remains on the patient teeth for the duration of surgery.
- Edentulous Fiducial Registration: For edentulous (toothless) patients, the surgeon drills ● several bone screws in the bone to serve as fiducials for the CT scan. The location of these bone screws establishes a link between the CT coordinate system and the patient's surgical anatomy. The surgeon then locates and marks the screws in the CT image in the X-Guide software. Just prior to surgery, an Edentulous Clip, CLX Tracker Arm, or EDX Tracker arm is attached to the patient. This device is necessary to attach the Patient Tracker to the patient, and facilitates the navigation and tracking process. The system is calibrated to the patient anatomy and CT by probing each of the fiducial screws and correlating these locations to the locations marked in the plan.
- X-Mark Registration: The CT scan of the patient is taken without any fiducials in the ● image. The doctor manually marks anatomical landmarks as fiducials instead, and because of this, this process is well suited for both dentate and edentulous patients. Once at least 3 anatomical landmarks are marked, the doctor registers the anatomical landmarks by touching them with the tip of a Probe Tool on the registration page. The tracking system tracks the relationship between the Patient Tracker and Probe Tracker to complete the patient registration.

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Image /page/9/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" with green, blue, and gray horizontal lines. The words "-NAV" are in a bold, dark blue font, and the word "TECHNOLOGIES" is in a smaller, light gray font below the main logo.

# Device Indications for Use

The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures.

The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments.

The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.

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Image /page/10/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made of horizontal bars in shades of green, blue, and gray. To the right of the "X" is the text "-NAV" in a bold, dark blue font, and below the "X" is the word "TECHNOLOGIES" in a smaller, gray font.

# Specifications

A comparison of the following specifications is itemized in the tables on the ensuing pages.

- . Use Specifications
- Technology / Performance Characteristics
- Safety Features ●
- Components
- Energy .

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Image /page/11/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a bold, dark blue font. Below the "X-NAV" text is the word "TECHNOLOGIES" in a smaller, light gray font.

## Use Specifications

| Use<br>Specifications | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K211701 | DTX Studio Clinic 3.0<br>(Reference Device for<br>automatic annotation<br>of the dental<br>mandibular canal) ;<br>K213562 | NobelClinician®, DTX<br>Studio Implant (Reference<br>Device for the alignment of<br>IOS to CBCT and guidance<br>of surgery); K163122 | Justification of<br>Differences |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use Statement | The X-Guide® Surgical Navigation<br>System is a computerized navigational<br>system intended to provide assistance in<br>both the preoperative planning phase and<br>the intra-operative surgical phase of dental<br>implantation procedures and/or endodontic<br>access procedures.<br>The system provides software to<br>preoperatively plan dental implantation<br>procedures and/or endodontics access<br>procedures and provides navigational<br>guidance of the surgical instruments.<br>The device is intended for use for partially<br>edentulous and edentulous adult and<br>geriatric patients who need dental implants<br>as a part of their treatment plan. The device<br>is also intended for endodontic access<br>procedures (i.e., apicoectomies and/or<br>access of calcified canals) where a CBCT<br>is deemed appropriate as part of their<br>treatment plan. | The X-Guide® Surgical Navigation System<br>is a computerized navigational system<br>intended to provide assistance in both the<br>preoperative planning phase and the intra-<br>operative surgical phase of dental<br>implantation procedures and/or endodontic<br>access procedures.<br>The system provides software to<br>preoperatively plan dental implantation<br>procedures and/or endodontics access<br>procedures and provides navigational<br>guidance of the surgical instruments.<br>The device is intended for use for partially<br>edentulous and edentulous adult and<br>geriatric patients who need dental implants<br>as a part of their treatment plan. The device<br>is also intended for endodontic access<br>procedures (i.e., apicoectomies and/or<br>access of calcified canals) where a CBCT is<br>deemed appropriate as part of their<br>treatment plan. | DTX Studio Clinic is a<br>software program for<br>the acquisition,<br>management, transfer<br>and analysis of dental<br>and<br>craniomaxillofacial<br>image information,<br>and can be used to<br>provide design input<br>for dental restorative<br>solutions. It displays<br>and enhances digital<br>images from various<br>sources to support the<br>diagnostic process and<br>treatment planning. It<br>stores and provides<br>these images within<br>the system or across<br>computer systems at<br>different locations. | NobelClinician® (DTX<br>Studio Implant) is a software<br>interface for the transfer and<br>visualization of 2D and 3D<br>image information from<br>equipment such as a CT<br>scanner for the purposes of<br>supporting the diagnostic<br>process, treatment planning<br>and follow-up in the dental<br>and cranio- maxillofacial<br>regions.<br>NobelClinician® (DTX<br>Studio Implant) can be used<br>to support guided implant<br>surgery and to provide<br>design input for and review<br>of dental restorative<br>solutions. The results can be<br>exported to be manufactured. | The subject device has the<br>same Indications for Use<br>as the predicate device.<br>The Reference devices are<br>software used in planning<br>dental and maxillofacial<br>surgery.<br>The proposed device<br>modification is limited in<br>scope to a change to the<br>pre-operative treatment<br>planning phase of the<br>software. The pre-<br>operative treatment<br>planning phase of the<br>software displays 2D and<br>3D images from various<br>sources.<br>A plan generated in<br>NobelClinician®, DTX<br>Studio Implant can be<br>used to fabricate a static<br>guide for use in surgery. |
| Intended User | Dentists | Dentists | Dentists | Dentists | No difference |
| Use<br>Environment | Clinical Setting, Doctor's Office | Clinical Setting, Doctor's Office | Clinical Setting,<br>Doctor's Office | Clinical Setting, Doctor's<br>Office | No difference |
| Technology / Performance<br>Characteristics | X-Guide® (Subject Device) | X-Guide®<br>(Predicate<br>Device) ; K211701 | DTX Studio Clinic 3.0<br>(Reference Device for<br>automatic annotation of the<br>dental mandibular canal) ;<br>K213562 | NobelClinician®, DTX<br>Studio Implant (Reference<br>Device for the alignment of<br>IOS to CBCT and guidance<br>of surgery); K163122 | Justification of Differences |
| Operating Temperature | 10 - 35 deg C | 10 - 35 deg C | Not applicable | Not applicable | No difference. |
| Operating Relative<br>Humidity | 30% - 90% non-condensing | 30% - 90% non-<br>condensing | Not applicable | Not applicable | No difference. |
| Operating/Transport Air<br>Pressure | 500 hPa-1060hPa | 500 hPa-1060hPa | Not applicable | Not applicable | No difference. |
| Transport Temperature | -20 - +60 deg C | -20 - +60 deg C | Not applicable | Not applicable | No difference. |
| Transport Humidity | 10% - 95% non-condensing | 10% - 95% non-<br>condensing | Not applicable | Not applicable | No difference. |
| Optical Radiation | LED, Risk Group 1 (minimal<br>risk) per IEC 62471-1 | LED, Risk Group<br>1 (minimal risk)<br>per IEC 62471-1 | Not applicable | Not applicable | No difference. |
| Tracking Technology | Stereo Cameras / LEDs /<br>Pattern | Stereo Cameras /<br>LEDs / Pattern | Not applicable | Not applicable | No difference. |
| Calibration Frequency | Prior to each surgery | Prior to each<br>surgery | Not applicable | Not applicable | No difference. |
| Overall System Accuracy<br>(RMS) | <1mm | <1mm | Not applicable | Not applicable | No difference. |
| Alarms | Audible, Visual | Audible, Visual | Not specified | Not specified…