(217 days)
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.
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.
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 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 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.
The provided text describes the X-Guide Surgical Navigation System, which includes a new feature: Automatic Image Processing (AIP) software integration (IconiX) using machine learning. This software is designed to segment and identify anatomical structures in maxillofacial CT scans and IntraOral Scans (IOS).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, pass/fail format with reported performance for EACH of the new ML-driven features. Instead, it states that "software verification and validation testing were conducted and documented" and that the "combined testing and analysis of results provides assurance that the device performs as intended."
However, the "Technology Performance Characteristics" table (pages 12-14) implicitly presents several performance characteristics that would have acceptance criteria for the base device, which are maintained. For the new ML features, the validation tests described aim to demonstrate "correct segmentations and visualizations," "automatically create a pan curve," "register (superimpose) the IOS over the CT," and "generate the X-Guide SurfiX."
Given the information, a table focusing on the new ML features would look like this:
| Acceptance Criteria (Implied from Validation Test Descriptions) | Reported Device Performance (Implied from Submission Outcome) |
|---|---|
| Machine Learning Outputs Validation: | Met: The device received 510(k) clearance, implying that the FDA found sufficient evidence that the ML software outputs "correct segmentations and visualizations for the expected patient population." |
| - Correct segmentation and identification of anatomical structures in CT (Teeth, Maxilla bone, Mandible bone, Maxillary Sinuses, Mandibular Nerve Canal) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) |
| - Correct segmentation and identification of anatomical structures in IOS (Teeth, Gingiva) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) |
| Machine Learning Software Verification: | Met: The device received 510(k) clearance, implying that the FDA found sufficient evidence that the ML software "meets specifications and requirements when integrated with the X-Guide System software." |
| - Ability to automatically create a pan curve to fit the arch (minimum of two teeth per sextant required) | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic pan curve creation where the predicate required manual marking. This functionality is considered similar to reference devices that also auto-generate pan curves. |
| - Ability to register (superimpose) the IOS over the CT automatically | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic IOS to CT registration where the predicate required manual point-matching. This functionality is considered similar to a reference device that also combines surface models from intraoral and CBCT scans. |
| - Ability to generate the X-Guide SurfiX from segmented teeth and bone for X-Mark Registration or Refinement | (Details not explicitly provided in the summary, but implied to be sufficient for clearance.) The new software provides automatic Surface Definition (SurfiX) where the predicate required manual selection. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the test set. It mentions "varied CT data" for training (page 5) but does not provide specifics for the validation/test set.
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions that users can "view and confirm the correctness and completeness of [ML] results and, if desired, replace or augment them with conventional tools/methods" (page 5), implying a human expert review process is part of the clinical workflow, but this does not detail how ground truth for the test set was established for regulatory validation.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document explicitly states: "No clinical studies were performed for the submission of this 510(k)." (page 19) Therefore, no MRMC study was conducted, and no effect size regarding human reader improvement with AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
The summary describes "Machine Learning Outputs Validation" and "Machine Learning Software Verification" (page 20).
- Machine Learning Outputs Validation: "This validation test demonstrates that the machine learning software outputs correct segmentations and visualizations for the expected patient population." This suggests an assessment of the algorithm's performance in generating segmentations in a standalone context (i.e., whether the outputs themselves were correct compared to ground truth).
- Machine Learning Software Verification: "This verification test demonstrates that the machine learning software meets specifications and requirements when integrated with the X-Guide System software..." This part focuses on the integrated performance.
While the details of the "Machine Learning Outputs Validation" are not provided, its description implies a standalone assessment of the ML algorithm's output accuracy against some form of ground truth.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for validating the machine learning outputs (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document mentions that the machine learning software is "trained on varied CT data" (page 5) but does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for the training set was established.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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:Applicant: | 21 FEB 2024X-Nav Technologies, LLC1555 Bustard Road, Suite 75Lansdale, PA. 19446 |
|---|---|
| Contact Person: | Kimberly ChanDirector of Regulatory Affairs and Quality AssurancePhone: 267-436-0414regulatory@x-navtech.com |
| Device Trade / Proprietary Name: | X-Guide Surgical Navigation SystemModel P007839Model P011000 |
| Device Name, Common/Usual: | Surgical Navigation System |
| Classification Name:Regulatory Class:Product Code: | 21 CFR 872.4120 (Bone Cutting Instrument and Accessories)IIQRY, PLV |
| Predicate Device:Reference Devices: | X-Guide® Surgical Navigation System (K211701)DTX Studio Clinic 3.0 (K213562)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
| UseSpecifications | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ; K211701 | DTX Studio Clinic 3.0(Reference Device forautomatic annotationof the dentalmandibular canal) ;K213562 | NobelClinician®, DTXStudio Implant (ReferenceDevice for the alignment ofIOS to CBCT and guidanceof surgery); K163122 | Justification ofDifferences |
|---|---|---|---|---|---|
| Indications forUse Statement | The X-Guide® Surgical NavigationSystem is a computerized navigationalsystem intended to provide assistance inboth the preoperative planning phase andthe intra-operative surgical phase of dentalimplantation procedures and/or endodonticaccess procedures.The system provides software topreoperatively plan dental implantationprocedures and/or endodontics accessprocedures and provides navigationalguidance of the surgical instruments.The device is intended for use for partiallyedentulous and edentulous adult andgeriatric patients who need dental implantsas a part of their treatment plan. The deviceis also intended for endodontic accessprocedures (i.e., apicoectomies and/oraccess of calcified canals) where a CBCTis deemed appropriate as part of theirtreatment plan. | The X-Guide® Surgical Navigation Systemis a computerized navigational systemintended to provide assistance in both thepreoperative planning phase and the intra-operative surgical phase of dentalimplantation procedures and/or endodonticaccess procedures.The system provides software topreoperatively plan dental implantationprocedures and/or endodontics accessprocedures and provides navigationalguidance of the surgical instruments.The device is intended for use for partiallyedentulous and edentulous adult andgeriatric patients who need dental implantsas a part of their treatment plan. The deviceis also intended for endodontic accessprocedures (i.e., apicoectomies and/oraccess of calcified canals) where a CBCT isdeemed appropriate as part of theirtreatment plan. | DTX Studio Clinic is asoftware program forthe acquisition,management, transferand analysis of dentalandcraniomaxillofacialimage information,and can be used toprovide design inputfor dental restorativesolutions. It displaysand enhances digitalimages from varioussources to support thediagnostic process andtreatment planning. Itstores and providesthese images withinthe system or acrosscomputer systems atdifferent locations. | NobelClinician® (DTXStudio Implant) is a softwareinterface for the transfer andvisualization of 2D and 3Dimage information fromequipment such as a CTscanner for the purposes ofsupporting the diagnosticprocess, treatment planningand follow-up in the dentaland cranio- maxillofacialregions.NobelClinician® (DTXStudio Implant) can be usedto support guided implantsurgery and to providedesign input for and reviewof dental restorativesolutions. The results can beexported to be manufactured. | The subject device has thesame Indications for Useas the predicate device.The Reference devices aresoftware used in planningdental and maxillofacialsurgery.The proposed devicemodification is limited inscope to a change to thepre-operative treatmentplanning phase of thesoftware. The pre-operative treatmentplanning phase of thesoftware displays 2D and3D images from varioussources.A plan generated inNobelClinician®, DTXStudio Implant can beused to fabricate a staticguide for use in surgery. |
| Intended User | Dentists | Dentists | Dentists | Dentists | No difference |
| UseEnvironment | Clinical Setting, Doctor's Office | Clinical Setting, Doctor's Office | Clinical Setting,Doctor's Office | Clinical Setting, Doctor'sOffice | No difference |
| Technology / PerformanceCharacteristics | X-Guide® (Subject Device) | X-Guide®(PredicateDevice) ; K211701 | DTX Studio Clinic 3.0(Reference Device forautomatic annotation of thedental mandibular canal) ;K213562 | NobelClinician®, DTXStudio Implant (ReferenceDevice for the alignment ofIOS to CBCT and guidanceof surgery); K163122 | Justification of Differences |
| Operating Temperature | 10 - 35 deg C | 10 - 35 deg C | Not applicable | Not applicable | No difference. |
| Operating RelativeHumidity | 30% - 90% non-condensing | 30% - 90% non-condensing | Not applicable | Not applicable | No difference. |
| Operating/Transport AirPressure | 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-condensing | Not applicable | Not applicable | No difference. |
| Optical Radiation | LED, Risk Group 1 (minimalrisk) per IEC 62471-1 | LED, Risk Group1 (minimal risk)per IEC 62471-1 | Not applicable | Not applicable | No difference. |
| Tracking Technology | Stereo Cameras / LEDs /Pattern | Stereo Cameras /LEDs / Pattern | Not applicable | Not applicable | No difference. |
| Calibration Frequency | Prior to each surgery | Prior to eachsurgery | Not applicable | Not applicable | No difference. |
| Overall System Accuracy(RMS) | <1mm | <1mm | Not applicable | Not applicable | No difference. |
| Alarms | Audible, Visual | Audible, Visual | Not specified | Not specified | No difference. |
| Monitor | LCD-TFT | LCD-TFT | Not specified | Not specified | No difference. |
| Communications Interface | Ethernet | Ethernet | Not specified | Not specified | No difference. |
| Software | Navigational Guidance andImplant/Trajectory Planning | NavigationalGuidance andImplant/TrajectoryPlanning | Acquisition, management,transfer and analysis of dentaland craniomaxillofacial imageinformation; design input fordental restorative solutions. Itdisplays and enhances imagesto support the diagnosticprocess and treatmentplanning | Guided implant surgeryplanning; design input andreview of dental restorativesolutions | No difference.The reference devices do not includenavigational guidance software,however, they can be used to plandental restorative solutions and/orguided implant surgery.NobelClinician®, DTX Studio Implantcan be used to fabricate a static surgicalguide. |
| Navigation Screens | Handpiece Navigation | HandpieceNavigation | Not applicable | Not applicable | No difference |
| Visualization | Visualize 2D and 3D imagedata. The user can applyimage filters and canmeasure length, angles andHU units.If found in the CBCT, theAutomatic Image Processing(AIP) software will overlaysegmented and identifiedteeth, maxilla bone,mandible bone, maxillarysinuses, and mandibularnerve canals on the CBCT. | Visualize 2D and3D image data.The user can applyimage filters andcan measurelength, angles andHU units. | Review and diagnose 2D and3D image data as well asclinical images. The user canapply image filters and canmeasure length, angles andHU units.Automatic annotation of themandibular canals based onanatomical landmarks | Review and diagnose 2D and3D image data to supportguided implant surgery andto provide design input forand review of dentalrestorative solutions | The difference between the subject andthe predicate is the subject of thisdevice modification, to allow theaddition of AIP to assist in planning.The software automatically segmentsthe teeth, maxilla bone, mandible bone,maxillary sinuses, and mandibularnerve canals. The user can alsomanually indicate the mandibular canalor manually indicate the tooth surfacesused for X-Mark.This functionality is similar as in thereference device DTX Studio Clinic 3.0(K213562), which automaticallyannotates the mandibular nerve canal.The mandibular nerve canal is a high-risk anatomical structure. The otheranatomical structures that the AIP isable to segment are of lower orequivalent risk. |
| Pan Curve Creation | AIP utilizes automatic toothidentifications to generate aproposed panoramic splinecurve on the arch.The user may still decide tomanually mark points onarch at certain teethlocations. The softwaregenerates a panoramic splinecurve. | User manuallymarks points onarch at certainteeth locations.The softwaregenerates apanoramic splinecurve. | Software automaticallygenerates a proposedpanoramic curve. | Software automaticallygenerates a proposedpanoramic curve. | The difference between the subject andthe predicate is the subject of thisdevice modification, to allow theaddition of AIP to generate a proposedpanoramic curve.The reference devices automaticallygenerate proposed pan curves. |
| Surface Definition | AIP utilizes automaticsegmentation definitions togenerate the surface("SurfiX").The user may also manuallychoose an isosurface HUvalue ("SurfiX"). | User manuallychooses anisosurface HUvalue ("SurfiX"). | No explicit surface definition.Volume Rendering TransferFunctions with IsovalueThresholding for visualization | No explicit surfacedefinition.Volume Rendering TransferFunctions with IsovalueThresholding forvisualization | The difference between the subject andthe predicate is the subject of thisdevice modification, to allow theaddition of AIP to assist insegmentation of anatomy and thedefinition of surfaces. |
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Image /page/12/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of blue, green, and gray horizontal bars. To the right of the "X" is the text "-NAV" in a bold, blue font, and below the entire logo is the word "TECHNOLOGIES" in a smaller, gray font.
Technology/Performance Characteristics
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Image /page/13/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up of horizontal bars in different colors, followed by the text "-NAV" in a bold, sans-serif font. Below the main logo, the word "TECHNOLOGIES" is written in a smaller, sans-serif font.
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Image /page/14/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" with green and gray stripes, followed by the text "-NAV" in a dark blue, sans-serif font. Below the "X-NAV" text, the word "TECHNOLOGIES" is written in a smaller, sans-serif font.
| IOS Registration | AIP registration of importedIOS to CTManual Registration of IOSto CT by Point-Matching | ManualRegistration ofIOS to CT byPoint-Matching | SmartFusion™ : directlycombining surface modelsfrom all intraoral and desktopscanners with any CBCT scanusing proprietary voxel-basedalgorithmsManual Registration of IOS toCT by Point-Matching | This surface information isaligned to DICOM data tosupport the prostheticimplant planning and guidedsurgery protocols.Manual Registration of IOSto CT by Point-Matching | The difference between the subject andthe predicate is the subject of thisdevice modification, to allow theaddition of AIP to assist in IOSRegistration. The softwareautomatically superimposes animported IOS to the CBCT. The usercan also manually select points toperform the superimposition in thesubject device.This functionality corresponds with thereference device NobelClinician®,DTX Studio Implant (K163122), whichallows for the superimposition of theIOS and the CBCT to support implantplanning. Nobel Clinician® (K163122)allows the user to fabricate surgicalguide templates based on the plan. |
|---|---|---|---|---|---|
| Dimensions | Height: 64.653 in (1642.19mm)Width: 21.011 in(533.67mm) | Height: 64.653 in(1642.19 mm)Width: 21.011 in(533.67mm) | Not applicable | Not applicable | No difference. |
| Mounting | Mobile Cart | Mobile Cart | Not applicable | Not applicable | No difference. |
| Configuration Weight | P007839: 102 kg (225 lb)P011000: 100kg (220 lb) | 130lbs. (58.97 kg) | Not applicable | Not applicable | Addition of weight to the bottom of thesystem for better tip-over resistance. |
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Image /page/15/Picture/0 description: The image is a logo for X-NAV Technologies. The X in the logo is made up of green, blue, and gray horizontal lines. The words "X-NAV" are in a bold, blue font, and the word "TECHNOLOGIES" is in a smaller, gray font below the X-NAV.
Safety Features
| Safety Features | X-Guide® (Subject Device) | X-Guide® (Predicate Device) ;K211701 | DTX Studio Clinic 3.0(Reference Device forautomatic annotationof the dentalmandibular canal) ;K213562 | NobelClinician®, DTXStudio Implant (ReferenceDevice for the alignment ofIOS to CBCT and guidanceof surgery); K163122 | Justification of Differences |
|---|---|---|---|---|---|
| Electrical Safety | IEC 60601-1:2005 Edition3.2AAMI ES60601-1:2005+A1:2009 +A2:2010EN 60601-1:2006ISO15223-1:2012BS EN ISO 14971:2019IEC 62304: 2006, A1:2015 | IEC 60601-1:2005 Edition3.1AAMI ES60601-1:2005+A1:2009 +A2:2010EN 60601-1:2006ISO15223-1:2012BS EN ISO 14971:2012IEC 62304: 2006, A1:2015 | Not applicable | Not applicable | Updated for latest RiskManagement (ISO 14971)Updated for latest 60601-1 |
| ElectromagneticCompatibility | IEC 60601-1-2:2014 ed 4.1 | IEC 60601-1-2:2014 4thEdition | Not applicable | Not applicable | Updated for latest 60601-1-2 |
| Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -12) | Yes (ISO 10993-1, -5, -10, -11, -12) | Not applicable | Not applicable | No difference |
| Sterilization | Steam | Steam | Not applicable | Not applicable | No difference |
| Disinfectant(High Level) | 3% Glutaraldehyde solution | 3% Glutaraldehyde solution | Not applicable | Not applicable | No difference |
| IngressProtection | IP2X | IP2X | Not applicable | Not applicable | No difference |
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Image /page/16/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo has a stylized X on the left side with green, blue, and gray horizontal lines. The words -NAV are in large blue font, and the word TECHNOLOGIES is in gray font below the X-NAV.
Components
| Components | X-Guide® (SubjectDevice) | X-Guide® (PredicateDevice) : K211701 | DTX Studio Clinic 3.0(Reference Device forautomatic annotationof the dentalmandibular canal) ;K213562 | NobelClinician®, DTXStudio Implant (ReferenceDevice for the alignment ofIOS to CBCT andguidance of surgerv);K163122 | Justification of Differences | ||
|---|---|---|---|---|---|---|---|
| Bone Screw | Bone Screw(s) | Bone Screw(s) | Not applicable | Not applicable | No difference | ||
| CT / PatientRegistration | X-Clip, OrganicFiducials, AnatomicalLandmarks | X-Clip, OrganicFiducials, AnatomicalLandmarks | Not applicable | Not applicable | No difference | ||
| Patient TrackingDevice | X-Corner PatientTracker | X-Corner PatientTracker | Not applicable | Not applicable | No difference | ||
| Surgical ToolTracking Device | X-Corner HandpieceTracker | X-Corner HandpieceTracker | Not applicable | Not applicable | No difference | ||
| Screwdriver | Yes | Yes | Not applicable | Not applicable | No difference | ||
| Edentulous PatientTracking AttachmentSystem | Edentulous Clip, EDXTracker Arms, CLXTracker Arms | Edentulous Clip, EDXTracker Arms, CLXTracker Arms | Not applicable | Not applicable | No difference | ||
| Registration Tool | Probe Tool | Probe Tool | Not applicable | Not applicable | No difference | ||
| Drill Bit LengthDetermination | Go Plate | Go Plate | Not applicable | Not applicable | No difference | ||
| Patient TrackerAttachment Arms | Posterior Tracker Arm;Anterior Tracker Arm | Posterior TrackerArm; Anterior TrackerArm | Not applicable | Not applicable | No difference | ||
| Energy | X-Guide®(SubjectDevice) | X-Guide®(PredicateDevice) ;K211701 | DTX Studio Clinic 3.0(Reference Device forautomatic annotationof the dentalmandibular canal) ;K213562 | NobelClinician®, DTX StudioImplant (Reference Device forthe alignment of IOS to CBCTand guidance of surgery);K163122 | Justification of Differences | ||
| Mains Voltage,Frequency | 115 VAC; 50 /60 Hz | 100 — 127VAC/ 200 –240VAC; 50 /60 Hz | Not applicable | Not applicable | There has been no physical change to the X-Guide SystemMains Voltage and Frequency. The X-Guide is not auto-ranging. It has always had a fixed nominal voltage. Thereason for the apparent change is due to the update to the X-Guide System's IEC 60601-1-2 test report nomenclature.The updated ed 4.1 test report Unit Under Test sectiondocuments the Rated (Nominal) Voltage. The original ed 3.0test report Unit Under Test section documents the range towhich the device was subject during the test. The ed 4.1 testreport's use of just the Nominal Voltage is more correct.115 VAC is the only configuration sold in the United Statesof America. Therefore, only the 115 VAC unit is included inthe subject device 510(k). | ||
| Input Power(VA) | 1000VA | 1500VA | Not applicable | Not applicable | The X-Guide System originally utilized an oversizedtransformer. This was updated in the IEC 60601-1-2 ed 4.1test report. | ||
| Fusing Type /Rating | CircuitBreaker:115VAC, 7A | Circuit Breaker:100-127VAC,10A | Not applicable | Not applicable | The X-Guide System has always had a fixed nominalvoltage. The reason for the apparent change in the inputvoltage is due to the update to the X-Guide System's IEC60601-1-2 test report nomenclature.The updated ed 4.1 test report Unit Under Test sectiondocuments the Rated (Nominal) Voltage. The original ed 3.0test report Unit Under Test section documents the range thatthe device was subject to during the test. The ed 4.1 testreport's use of just the Nominal Voltage is more correct.The change to the breaker is because the X-Guide Systemoriginally utilized an oversized circuit breaker. This wasupdated from 10 A to 7 A in the IEC 60601-1-2 ed 4.1 testreport. | ||
| Degree ofProtectionAgainstElectricalShock | Applied PartType B | Applied PartType B | Not applicable | Not applicable | No difference | ||
| Type ofProtectionAgainstElectricalShock | Class I | Class I | Not applicable | Not applicable | No difference | ||
| Mode ofOperation | Continuous | Continuous | Not applicable | Not applicable | No difference |
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Image /page/17/Picture/0 description: The image shows the logo for X-NAV Technologies. The logo features a stylized "X" made up of green, blue, and gray bars. The words "-NAV" are in a bold, dark blue font, and the word "TECHNOLOGIES" is in a light gray font below the "X-NAV".
Energy
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Image /page/18/Picture/0 description: The image is a logo for X-NAV Technologies. The logo features a stylized "X" made up 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. Below the "X-NAV" text is the word "TECHNOLOGIES" in a smaller, light gray font.
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Image /page/19/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 geometric shapes. To the right of the "X" is the text "-NAV" in a bold, dark blue font. Below the "X" and "-NAV" is the text "TECHNOLOGIES" in a smaller, light gray font.
Performance Testing
No performance standards have been established for Dental Stereotaxic Instruments under Section 514 of the Food, Drug and Cosmetic Act.
There are no changes to Biocompatibility, cleaning and sterilization, electromagnetic compatibility. There are no changes to the physical X-Guide System itself or any of its components. The only change was to software.
Clinical Studies
No clinical studies were performed for the submission of this 510(k).
Non-Clinical Assessment
FDA Guidance Documents
X-Nav Technologies utilized the following FDA Guidance Documents in the preparation of this 510(k):
- · Guidance for the Content of Premarket Submissions for Device Software Functions
- · Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions .
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions 트
- Good Machine Learning Practice for Medical Device Development: Guiding Principles ■
Software Development
Software development was conducted and documented in accordance to IEC 62304:2006+AMD1:2015.
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Image /page/20/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 blue, green, and gray. To the right of the "X" is the word "NAV" in large, bold, dark blue letters, and below the letters is the word "TECHNOLOGIES" in smaller, light gray letters.
Software and System Verification and Validation Testing
Software verification and validation testing were conducted and documented. The combined testing and analysis of results provides assurance that the device performs as intended.
| Verification/Validation Type | Description |
|---|---|
| Machine Learning Outputs Validation | This validation test demonstrates that the machine learning software outputs correct segmentations and visualizations for the expected patient population. |
| Machine Learning Software Verification | This verification test demonstrates that the machine learning software meets specifications and requirements when integrated with the X-Guide System software, including the ability to automatically create a pan curve to fit the arch, register (superimpose) the IOS over the CT, and generate the X-Guide SurfiX. |
Risk Analysis
A Product Risk Analysis was conducted in accordance with ISO 14971:2019 to review the following elements specific to the change:
- · The risks associated with the use, usability and performance of the device
- · the risks associated with and specific to the software design aspects of the device
- · the risks associated with software functionality and software interaction with the user
Results were updated in the X-Guide Risk Analysis.
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Image /page/21/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 word "NAV" in large, bold, dark blue letters. Below the "X-NAV" portion of the logo is the word "TECHNOLOGIES" in smaller, gray letters.
Conclusions
Based upon the information provided within this 510(k) Premarket Notification, we conclude that the X-Guide® Surgical Navigation System with integrated automatic image processing via machine learning software is substantially equivalent to the identified predicate device.
§ 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.