(130 days)
No
The description focuses on optical tracking and image processing for real-time guidance, without mentioning AI or ML algorithms.
Yes
The device aids in surgical procedures by providing real-time guidance for instrument placement during dental implantations, which is a therapeutic intervention.
No
The INLIANT Surgical Navigation System is a computerized surgical navigation system intended to assist in pre-operative planning and intra-operative guidance for dental implantation procedures. It provides real-time guidance of surgical instruments relative to the patient's anatomy and planned implant position, but it does not diagnose medical conditions.
No
The device description explicitly states that the system includes hardware components such as a stand-alone cart, computer, monitor, camera (with image sensors and lens assemblies), handpiece, Patient Trackers, and Fiducial Kit. While software is a critical part of the system, it is not the only component.
Based on the provided information, the INLIANT Surgical Navigation System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The INLIANT system is used directly on the patient during a surgical procedure to guide instruments based on imaging data. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for surgical guidance. The system's purpose is to assist in pre-operative planning and intra-operative navigation for dental implant placement. This is a surgical intervention, not a diagnostic test performed on a specimen.
- The device description focuses on optical tracking and real-time guidance. The technology described involves tracking the position of surgical tools relative to the patient's anatomy, which is a characteristic of surgical navigation systems, not IVDs.
Therefore, the INLIANT Surgical Navigation System falls under the category of a surgical navigation system rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.
INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.
Product codes
PLV
Device Description
INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure.
INLIANT includes a stand-alone cart which provides mobility and structural support for the computer, monitor and the camera which consists of two high resolution optical image sensors and lens assemblies. The system also includes the handpiece (model WI-75 LED G cleared under K080939), Patient Trackers and Fiducial Kit.
Operation of INLIANT is based on optical tracking. Stereoscopic images of the markers on the Patient Tracker and a handpiece are captured by the camera above the surgical site. INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.
Mentions image processing
INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computerized Tomography
Anatomical Site
Jaw / dental
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Software Validation and documentation for software of moderate level of concern was provided per . the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All software verification/validation passed.
- Cybersecurity Evaluation per the FDA Guidance Document "Content of Premarket Submissions for ● Management of Cybersecurity in Medical Devices."
- Cleaning and disinfection validations were performed in accordance with FDA Guidance document ● "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. All testing passed.
- Steam Sterilization Validation was conducted in accordance with ANSVAAMI/ISO 17665-1, ISO . 17665-2, and ANSI/AAMI ST79. All testing passed.
- Gamma radiation validation per ISO 11137-1 and -2 and shelf life/package integrity validation per . ISO 11607-1, ASTM F2096, and ASTM F88.
- . Biocompatibility assessment and testing was conducted per FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The patient contacting components of the device passed cytotoxicity, sensitization, intracutaneous irritation, and oral mucosa irritation biocompatibility testing.
- . Performance testing was conducted to evaluate the tolerance analysis, latency, positional and tracking accuracy per ASTM F2554, tracker environmental conditions, drill length measurement accuracy, system verification, and design validation. The acceptance criteria were met.
Usability Testing:
A usability validation testing included 8 participants from 8 clinics. The study was conducted at Navigate Surgical Technologies Inc, in a simulated dental clinic operatory. Observational data were collected during the testing and participants completed a questionnaire. Analysis of the data demonstrated that the INLIANT System's user interface performed as expected for the intended users, uses, and use environments, and that no further modification to the user interface was necessary.
Clinical Performance:
Clinical testing was performed. The purpose of the clinical study was to confirm that the corrective actions identified in the Root Cause Analysis successfully reduce the angular inaccuracy of dental implants placed using the INLIANT device in a clinical setting. Specifically, it is designed to confirm that the INLIANT device is equivalent to the predicate device by measuring the angular and lateral deviations between the planned and placed implant positions. The study employed a confirmatory, single-clinic, non-randomized study of the INLIANT device to aid dental implant placement. A total of 23 implants were placed among 22 adult subjects. The subject population were dental clinic patients, male and female adults age 22 years and older in good general health in need of 1-2 implants with each tooth having at least two adiacent zero mobility teeth in the same arch on which surgery was to be performed. Four investigators used INLIANT to place the dental implants. Deviations between the planned implant positions and placed implant positions were measured. The study endpoints were evaluated by the lateral (coronal and apical) and angular deviations between the pre-planned implant positions and actual implant positions were measured by registering pre-operative and post-operative CBCT scans in a common reference. Patients were followed up 2-4 weeks post-surgery.
The primary study research question inquired as to the probability of having all three of the lateral and angulation measurements be statistically less than their respective noninferiority upper equivalence bounds that preserve 80% of the advantage of the predicate device compared to freehand. These bounds are 3.903° for angular deviation, 0.8661 mm for coronal lateral deviation, and 1.145 mm for apical lateral deviation. Results for all three types of deviations support the conclusion that the deviations are significantly different than their respective upper equivalence bound, and non-inferior to the predicate. There were no adverse events reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Navigate Surgical Technologies Inc. % Pamela Buckman Regulatory/Clinical Consultant Pamela Buckman, MSN 921 Calle Verde Martinez, California 94553
Re: K213392
Trade/Device Name: INLIANT® Surgical Navigation System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 23, 2021 Received: November 26, 2021
Dear Pamela Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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
2
Indications for Use
510(k) Number (if known) K213392
Device Name INLIANT® Surgical Navigation System
Indications for Use (Describe)
The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.
INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ | ☐ |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K213392
General Information
Date Prepared: February 22, 2022
Proprietary Name: INLIANT® Surgical Navigation System
Common Name: Dental Stereotaxic Instrument
Classification Name: Bone Cutting Instrument and Accessories
Regulation: 21 CFR 872.4120
Regulatory Class: Class II
FDA Panel: Dental
Product Code: PLV
Applicant:
Navigate Surgical Technologies, Inc. 25 E 6th Ave, Suite 302 Vancouver, BC V5T 1J3 Marty Dymek, CEO marty@navigatesurgical.com
Contact: Pamela M. Buckman, MSN 921 Calle Verde Martinez, CA d4553 925 980 7007 (mobile) pmbuckman@gmail.com
Indication for Use: The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both the pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.
INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.
4
Predicate Device: K150222 (X-Guide Surgical Navigation System)
Device Description: INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure.
INLIANT includes a stand-alone cart which provides mobility and structural support for the computer, monitor and the camera which consists of two high resolution optical image sensors and lens assemblies. The system also includes the handpiece (model WI-75 LED G cleared under K080939), Patient Trackers and Fiducial Kit.
Operation of INLIANT is based on optical tracking. Stereoscopic images of the markers on the Patient Tracker and a handpiece are captured by the camera above the surgical site. INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.
Comparison of Technological Characteristics: The INLIANT Surgical Navigation System (INLIANT) and the predicate device, X-Guide Surgical Navigation System (X-Guide), provide three-dimensional (3D) orientation and position of surgical tools displayed on a computer monitor in real-time within a patient's 3D imaging data set (CT images). Both systems utilize a dynamic computer-assisted surgery system based on optical motion tracking technology which tracks the position of the surgical tool to a sub-millimeter accuracy relative to the position of the patient throughout dental implant osteotomy preparation. Neither device is intended to replace human assessment, but to provide objective information relating to the positioning and alignment of the surgical tools in reference to the patient's anatomy.
5
INLIANT and the predicate device share many characteristics. These characteristics are provided in the following table:
| Characteristic | INLIANT (subject) | X- Guide
(predicate) | Comparison/Conclusion |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | INLIANT is a
computerized
navigational system
intended to provide
assistance in both
the pre-operative
planning and the
intra-operative
surgical phase of
dental implantation
procedures.
INLIANT provides
software to pre-
operatively plan
dental implantation
procedures and
provides
navigational
guidance of surgical
instruments. The
device is intended
for use for partially
edentulous adult
patients who require
dental implants as
part of their
treatment plan. | The X-Guide
Surgical Navigation
System is a
computerized
navigational system
intended to provide
assistance in both
the pre-operative
planning phase and
the intra-operative
surgical phase of
dental implantation
procedures. The
system provides
software to pre-
operatively plan
dental implantation
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
part of their
treatment plan. | The INLIANT is not
intended for fully
edentulous patients or
geriatric patients as
indicated in the predicate.
The exclusion of fully
edentulous patients and
geriatric patients does not
impact substantial
equivalence as the
INLIANT intended for use
on a subset of the patient
population of the
predicate, partially
edentulous patients. |
| Main Functions | CT-based implant
placement planning.
Presentation of
position, angle, and
depth indicators
when drilling in the
jaw. | CT-based implant
placement planning.
Presentation of
position, angle and
depth indicators
when drilling in the
jaw. | Identical |
| Characteristic | INLIANT (subject) | X- Guide
(predicate) | Comparison/Conclusion |
| Performance Characteristics | | | |
| Accuracy at the
Drill Tip | $\leq1.0mm$ | $\leq1.0mm$ | Identical |
| Presentation Update
Rate | Real time | Real time | Identical |
| Technological Characteristics | | | |
| Input Imaging
Modality | Computerized
Tomography | Computerized
Tomography | Identical |
| Dynamic Object
Pose Measurement
Technology | Stereoscopic
triangulation of
marker patterns. | Stereoscopic
triangulation of
illuminated
checker-board
patterns (X-
Corners). | Equivalent |
| Hand piece tracking | Optical marker
patterns on the
hand piece. | An optically
marked tube-like
attachment to the
back of the hand
piece. | Equivalent |
| Jaw Tracking
Attachment | INLIANT Fiducial
is a nonconductive
plastic piece with
embedded
radiopaque spheres.
Molded
thermoplastic is
inserted into the
INLIANT Fiducial
tray and placed on
available dentition
to form the Stent.
During surgery,
Patient Tracker
(optically marked)
is connected to the
Fiducial | U- shaped "X-clip"
with a molded
thermoplastic insert,
mounted on the
available dentition.
During surgery, a
metallic arm holding
an optically marked
metal cylinder is
connected to it. | Equivalent.
In both systems, a
thermoplastic part is
molded to the surface of
the jaw to provide a
coupling to the teeth with
the optically tracked
object rigidly connected
to the molded part. |
| Patient to CT Image
Registration | Automatic, using
small radiopaque
spheres embedded
in a uniquely
shaped,
nonconductive
plastic piece | Manual, using small
fiducial spheres
embedded in the X-
clip and a jaw
tracker calibration
process. | Equivalent.
In both systems, fiducial
objects of known shapes
are used to obtain a
registration mapping
between the patient jaw |
| | | | and the CT image. |
| Jaw Attachment
Calibration | Not needed | Needed prior to
each operation.
Different
procedures
depending on the
type of attachment. | Equivalent.
INLIANT markers
on Patient Tracker
are permanent and
pre- calibrated. |
| Characteristic | INLIANT (subject) | X- Guide
(predicate) | Comparison/Conclusion |
| Drill length
measurement | Drill length
measurement is
done by touching a
point on the Patient
Tracker. Drill
length
measurement is
followed by
"anatomy check" to
confirm system's
accuracy. Drill
length
measurement is
done after every
drill change. | Initial hand piece
calibration is done
using hand piece
calibration disc (a
special optically
marked tool) while
drill bit length
calculation is done
by touching a point
on a Go-plate
(another optically
marked tool). Drill
length
measurement is
followed by
"anatomy check" to
confirm system's
accuracy. Drill
length measurement
is done after every
drill change. | Equivalent.
INLIANT markers on
hand piece are
permanent and pre-
calibrated. Patient
Tracker is used to
perform the drill length
measurement. |
| Mount Configuration | Mobile cart | Mobile cart | Identical |
| 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. | Identical |
| llumination of
tracking targets | Visible light
emitted by existing
dental light or
operatory lighting. | Visible light
emitted by LED
panel | Equivalent |
6
7
8
Non-Clinical Testing: Device testing was conducted to evaluate conformance to product specifications and applicable standards. Conclusions drawn from these non-clinical tests demonstrate that INLIANT is substantially equivalent to the predicate device. The following standards were applied:
- Guidance on Premarket Notification [510(k)] Submissions for Medical Devices ●
- EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for . regulatory purposes
- EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
- IEC 62304:2006 Medical device software. Software life cycle processes ●
- IEC 62366:2008 Medical devices. Application of usability engineering to medical devices
- . IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for safety --● Collateral Standard: Usability
Bench Testing:
- Software Validation and documentation for software of moderate level of concern was provided per . the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All software verification/validation passed.
- Cybersecurity Evaluation per the FDA Guidance Document "Content of Premarket Submissions for ● Management of Cybersecurity in Medical Devices."
- Cleaning and disinfection validations were performed in accordance with FDA Guidance document ● "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. All testing passed.
- Steam Sterilization Validation was conducted in accordance with ANSVAAMI/ISO 17665-1, ISO . 17665-2, and ANSI/AAMI ST79. All testing passed.
- Gamma radiation validation per ISO 11137-1 and -2 and shelf life/package integrity validation per . ISO 11607-1, ASTM F2096, and ASTM F88.
- . Biocompatibility assessment and testing was conducted per FDA Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The patient contacting components of the device passed cytotoxicity, sensitization, intracutaneous irritation, and oral mucosa irritation biocompatibility testing.
- . Performance testing was conducted to evaluate the tolerance analysis, latency, positional and tracking accuracy per ASTM F2554, tracker environmental conditions, drill length measurement accuracy, system verification, and design validation. The acceptance criteria were met.
9
Usability Testing: A usability validation testing included 8 participants from 8 clinics. The study was conducted at Navigate Surgical Technologies Inc, in a simulated dental clinic operatory. Observational data were collected during the testing and participants completed a questionnaire. Analysis of the data demonstrated that the INLIANT System's user interface performed as expected for the intended users, uses, and use environments, and that no further modification to the user interface was necessary.
Animal testing: No animal testing was conducted or included in support of the INLIANT submission.
Clinical Performance: Clinical testing was performed. The purpose of the clinical study was to confirm that the corrective actions identified in the Root Cause Analysis successfully reduce the angular inaccuracy of dental implants placed using the INLIANT device in a clinical setting. Specifically, it is designed to confirm that the INLIANT device is equivalent to the predicate device by measuring the angular and lateral deviations between the planned and placed implant positions. The study employed a confirmatory, single-clinic, non-randomized study of the INLIANT device to aid dental implant placement. A total of 23 implants were placed among 22 adult subjects. The subject population were dental clinic patients, male and female adults age 22 years and older in good general health in need of 1-2 implants with each tooth having at least two adiacent zero mobility teeth in the same arch on which surgery was to be performed. Four investigators used INLIANT to place the dental implants. Deviations between the planned implant positions and placed implant positions were measured. The study endpoints were evaluated by the lateral (coronal and apical) and angular deviations between the pre-planned implant positions and actual implant positions were measured by registering pre-operative and post-operative CBCT scans in a common reference. Patients were followed up 2-4 weeks postsurgery.
The primary study research question inquired as to the probability of having all three of the lateral and angulation measurements be statistically less than their respective noninferiority upper equivalence bounds that preserve 80% of the advantage of the predicate device compared to freehand. These bounds are 3.903° for angular deviation, 0.8661 mm for coronal lateral deviation, and 1.145 mm for apical lateral deviation. Results for all three types of deviations support the conclusion that the deviations are significantly different than their respective upper equivalence bound, and non-inferior to the predicate. There were no adverse events reported.
CONCLUSION
The summary includes the conclusions drawn from the nonclinical and clinical tests demonstrate that the device is substantially equivalent to the predicate device.