Neocis Guidance System (NGS) with Chairside Splint

K173402 · Neocis, Inc. · PLV · Feb 22, 2018 · Dental

Device Facts

• Record ID: K173402
• Device Name: Neocis Guidance System (NGS) with Chairside Splint
• Applicant: Neocis, Inc.
• Product Code: PLV · Dental
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2

Intended Use

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

Device Story

NGS is a stereotaxic dental surgical system. Input: patient CT scan. Operation: surgeon uses planning software to place virtual implants on CT scan; intra-operatively, system tracks patient via Chairside Splint and Patient Tracker; Guidance Arm physically constrains dental drill to follow pre-operative plan. Output: real-time 3D/2D visual feedback on drill position/orientation relative to plan; physical guidance of drill. Used in dental clinics by surgeons. System adjusts guidance in real-time if patient moves. Benefits: improved accuracy of implant placement, avoidance of critical anatomical structures. Surgeon retains final clinical decision-making authority.

Clinical Evidence

Clinical study evaluated human factors of Chairside Splint application/removal. Study included 15 dentists across two sites with 75 subjects (upper and lower jaw). Endpoints: duration of application/removal, adverse events (acrylic fixation, removal, aspiration/swallowing), and investigator subjective evaluation. Results showed no significant adverse events or complications; performance equivalent to predicate.

Technological Characteristics

Stereotaxic navigational system. Materials: Ixef HC-1022. Energy: 120V AC, 60Hz, 600VA. Accuracy: RMS < 1mm (lateral/depth), < 6.0° (angular). Connectivity: System tracks patient via mechanical Patient Tracker and fiducial array. Sterilization: Steam (reusable components). Software: Moderate level of concern. Compliance: IEC 60601-1, IEC 60601-1-2, ISO 10993, ISO 14971.

Indications for Use

Indicated for dental implantation surgery planning and intra-operative navigational guidance of surgical instruments.

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

• Neocis Guidance System (K161399)

Reference Devices

• Lang Jet Tooth Shade Dental Acrylic (K083195)

Submission Summary (Full Text)

{0}------------------------------------------------

February 22, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Neocis Inc. Alon Mozes, Ph.D. CEO and Co-Founder 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K173402

Trade/Device Name: Neocis Guidance System (NGS) with Chairside Splint Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: January 22, 2018 Received: January 25, 2018

Dear Alon Mozes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Mary S. Runner -S

> > For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K173402

#### Device Name

Neocis Guidance System (NGS) with Chairside Splint

Indications for Use (Describe)

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

| 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 [e-mail]

"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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the "neo" portion in yellow and the "cis" portion in gray. Above the word is a gray line, and to the right of the word is a gray circle with lines extending from it in four directions.

# Section 7. 510(k) Summary

| Submitter Name: | Neocis Inc.<br>2800 Biscayne Blvd.<br>Suite 600<br>Miami, FL 33137<br>Tel: 1-855-9NEOCIS |
|----------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Alon Mozes, Ph.D.<br>2800 Biscayne Blvd.<br>Suite 600<br>Miami, FL 33137<br>Tel: [phone] |
| Date Prepared: | January 22, 2018 |
| Trade Name: | Neocis Guidance System (NGS) with Chairside Splint |
| Common Name: | Dental Stereotaxic Instrument |
| Classification Name: | Bone cutting instrument and accessories (21 CFR 872.4120) |
| Classification: | Class II |
| Product Code: | PLV |
| Predicate Device: | Neocis Guidance System (K161399) |

### Indications for Use:

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

### Device Description:

The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.

Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font and is colored in yellow. Above the word is a gray line, and to the right of the word is a gray symbol that looks like a plus sign with a circle in the middle.

not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.

Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.

The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.

The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.

The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. A gray vertical line intersects the horizontal line at a point above the "i" in "neocis", forming a crosshair-like symbol.

# Comparison of Technological Characteristics:

This submission involves only a modification to the Patient Splint for the NGS. The new version will be referred to as the Chairside Splint, to be differentiated from the previous Patient Splint. Otherwise, all performance characteristics of the NGS are the same. The Chairside Splint involves a modification that allows for a chairside creation of the Patient Splint rather than requiring a patient impression and model and fabrication through a dental lab. The differences introduced by this modification are detailed in Table 1.

| Technological<br>Characteristics | NGS with Chairside Splint | NGS with Patient Splint | Comments |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device (K161399) | |
| Indications for Use | | | |
| Indications for<br>Use | The Neocis Guidance System<br>(NGS) is a computerized<br>navigational system intended<br>to provide assistance in both<br>the planning (pre-operative)<br>and the surgical (intra-<br>operative) phases of dental<br>implantation surgery. The<br>system provides software to<br>preoperatively plan dental<br>implantation procedures and<br>provides navigational guidance<br>of the surgical instruments. | The Neocis Guidance System<br>(NGS) is a computerized<br>navigational system intended<br>to provide assistance in both<br>the planning (pre-operative)<br>and the surgical (intra-<br>operative) phases of dental<br>implantation surgery. The<br>system provides software to<br>preoperatively plan dental<br>implantation procedures and<br>provides navigational guidance<br>of the surgical instruments. | No difference |
| Materials | | | |
| Materials | lxef®-HC-1022 | lxef®-HC-1022 | No difference |
| Technology / Performance Characteristics | | | |
| Supply Voltage | 120 V | 120 V | No difference |
| Phases | 1 | 1 | No difference |
| Type of Current | AC | AC | No difference |
| Rated Frequency<br>(Hz) | 60 Hz | 60 Hz | No difference |
| Rated Power<br>Input (VA) | 600 VA | 600 VA | No difference |
| Types and<br>Ratings of<br>external<br>accessible fuses | 5.0 A for 240 V | 5.0 A for 240 V | No difference |
| Type of Protection<br>against Electric<br>Shock | Class I Equipment | Class I Equipment | No difference |
| Degree of<br>Protection against<br>Electric Shock | Type BF | Type BF | No difference |
| Technological | NGS with Chairside Splint | NGS with Patient Splint | Comments |
| Characteristics | Subject Device | Predicate Device (K161399) | |
| Equipment<br>Suitable for use in<br>the presence of<br>Flammable<br>Mixtures? | No | No | No difference |
| Mode of<br>Operation | Continuous Operation | Continuous Operation | No difference |
| System Lateral<br>Accuracy | RMS < 1 mm | RMS < 1 mm | No difference |
| System Depth<br>Accuracy | RMS < 1 mm | RMS < 1 mm | No difference |
| System Angular<br>Accuracy | RMS < 6.0° | RMS < 6.0° | No difference |
| CT Scan Quality<br>Requirements | 0.3 mm Voxel, 0.3 mm Slice<br>Thickness, Matrix 512x512, Full<br>13cm 21 sec, Multi 2 DICOM<br>format. | 0.3 mm Voxel, 0.3 mm Slice<br>Thickness, Matrix 512x512, Full<br>13cm 21 sec, Multi 2 DICOM<br>format. | No difference |
| F/T Sensor Force<br>Measurement<br>Range | +/- 30 N | +/- 30 N | No difference |
| F/T Sensor<br>Torque<br>Measurement Ra<br>nge | +/- 2 Nm | +/- 2 Nm | No difference |
| F/T Sensor Single<br>Axis Force<br>Overload Limit | 200 N | 200 N | No difference |
| F/T Sensor Single<br>Axis Torque<br>Overload Limit | 20 Nm | 20 Nm | No difference |
| Upper limit<br>specification for<br>Guidance Arm<br>Translation Speed | 1.25 m/s | 1.25 m/s | No difference |
| Storage<br>Requirements | Store powered at Room<br>Temperature (68°F to 76°F or<br>20°C to 24.4°C) and standard<br>ambient humidity (5% to 95%) in a<br>dust free, clean environment. | Store powered at Room<br>Temperature (68°F to 76°F or<br>20°C to 24.4°C) and standard<br>ambient humidity (5% to 95%) in a<br>dust free, clean environment. | No difference |
| Splint Attachment | Chairside Splint can be attached<br>chairside with use of acrylic or<br>developed with acrylic on a patient<br>model in a dental lab. | Patient Splint is developed with<br>acrylic on a patient model in a<br>dental lab. | Difference in splint<br>attachment has<br>been verified and<br>validated through<br>nonclinical and<br>clinical testing. |
| Splint Removal | Chairside Splint may be removed<br>either by cutting bridges along a<br>seam of the splint or manually<br>pulling off. | Patient Splint is removed by<br>manually pulling off. | Difference in splint<br>removal has been<br>verified and<br>validated through<br>nonclinical and<br>clinical testing. |
| Fiducial Array<br>Attachment to | The Fiducial Array attaches to the<br>splint during the CT scan to | The Fiducial Array attaches to the<br>splint during the CT scan to | No difference |
| Technological<br>Characteristics | NGS with Chairside Splint | NGS with Patient Splint | Comments |
| | Subject Device | Predicate Device (K161399) | |
| Splint | provide a reference in the image. | provide a reference in the image. | |
| Kinematic Mount<br>Attachment to<br>Splint | The Kinematic Mount attaches to<br>the splint to provide a mounting<br>point for the Fiducial Array and<br>Patient Tracker. | The Kinematic Mount attaches to<br>the splint to provide a mounting<br>point for the Fiducial Array and<br>Patient Tracker. | No difference |
| Splint Shape and<br>Kinematic Mount<br>Location | The shape of the splint and the<br>location of the Kinematic Mount<br>attachment point are designed to<br>allow for proper ergonomic<br>approach of the Patient Tracker<br>and Guidance Arm. | The shape of the splint and the<br>location of the Kinematic Mount<br>attachment point are designed to<br>allow for proper ergonomic<br>approach of the Patient Tracker<br>and Guidance Arm. | No difference |
| Safety Features | | | |
| Biocompatibility | Yes (ISO 10993-1, -5, -10, -11, -<br>12) | Yes (ISO 10993-1, -5, -10, -11, -<br>12) | No difference |
| Sterilization | Steam | Steam | No difference. Both<br>splint versions are<br>disposable and one-<br>time use. |
| Components | | | |
| Patient Tracking<br>Device | Patient Tracker | Patient Tracker | No difference |
| Patient Tracking<br>Attachment<br>System | Chairside Splint | Patient Splint | Intended use for<br>these items is the<br>same. |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Neocis. The logo is a stylized wordmark with the word "neocis" in a sans-serif font. The letters are connected by a horizontal line above the word. There is a small circle above the "i" in "neocis".

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. There is a gray circle above the "i" in "neocis" with a vertical line extending upwards from the circle.

# Table 1: Summary of Technological Characteristics Comparison

# Performance Testing:

# Non-clinical Testing

Chairside Splint verification and validation testing is described below in Table 2.

| Verification / Validation<br>Type | Description |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use (End User Validation) | Run through of typical splint affixation cases using typodonts, performed by Surgeons. |
| Total System Accuracy | The Total System was evaluated for accuracy via simulated use with a typodont as simulation of a patient with three osteotomies per typodont in four locations (Upper Right / Upper Left / Lower Right / Lower Left). |
| Patient Tracker and Splint Mounting Verifications | Evaluating the effect of 2x Patient Tracker weight as total downward force on a standard splint mounted on a typodont per the IFU. In addition, evaluation of kinematic mount repeatability and patient anatomy accommodation analysis. |

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends slightly beyond the letters on either side. A gray vertical line intersects the horizontal line at the center, forming a cross shape with a small circle at the intersection point.

### Table 2: Summary of component and system verification and validation.

The subject of this 510(k) was only a modification to the patient splint. As such, non-clinical testing performed in support of clearance of the predicate NGS itself did not need to be repeated. Below is a list of the non-clinical testing performed on the predicate NGS that were relied upon for clearance of the modified splint.

### Biocompatibility Testing

The biocompatibility evaluation for NGS components was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10).

The components of the NGS are considered tissue contacting for a duration of less than 24 hours.

### Cleaning and Sterilization Validation

A representative sample of the re-usable NGS components were tested to validate that the components can withstand the steam sterilization process and that acceptable sterility is achieved using the recommended sterilization protocols. The sterilization validation testing was conducted according to ISO 17665-1:2006 and it validated that the reusable NGS components can be sterilized to reach an acceptable sterility assurance level.

### Electrical Safety and Electromagnetic Compatibility (EMC)

Comprehensive performance testing has been conducted on the NGS in accordance with various recognized industry standards, by a recognized third party organization. IEC 60601-1:2005 + Corr. 1 (2006) + Corr. 2 (2007) ANSI/AAMI ES60601-1:2005@2012 and C1:2009/® 2012 and A2:2010/® 2012 (Consolidated Text) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance was used for product safety and IEC 60601-1-2:2007 was used for EMC.

### Software and System Verification and Validation

Software and system verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in result in minor injury to the patient or operator.

Software Development and Testing was performed per IEC 62304: 2006 Medical Device Software - Software Lifecycle Processes, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002).

Risk analysis was conducted in compliance with ISO 14971: 2012 and includes FMEA analysis to review the following:

- · risks associated with the use, usability and performance of the device (Use FMEA)
- · the risks associated with and specific to the design aspects of the device (Design FMEA)

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in yellow. Above the word is a gray line that extends to the right, where it connects to a gray circle. A vertical gray line extends up and down from the circle, creating a cross-like shape.

- · the risks associated with the electrical safety of the device design as it applies to IEC 60601-1 (60601 FMEA)
- the risks associated with software functionality and software interaction with the user (Software FMEA)

The combined software and system testing and analysis of results (details in Table 3 below) provide assurance that the device performs as intended.

| Verification / Validation<br>Type | Description |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Simulated Use | Run through of Typical Use Case |
| Boundary Condition | Testing of all potential boundary parameters in the Application<br>Software |
| Registration | Testing of registration process |
| Case File Contents | Simulated use testing of features associated with saving / loading<br>Cases |
| Error Case Injection | Simulating all error messages and pop-ups. |
| CT Scan Verification | Verification of the resolution and validity of CT Scans |
| Control SW Boundary<br>Condition Testing | Testing the mechanical boundaries of the Control Software and<br>Guidance Arm. |
| Control Software Gravity<br>Calibration Verification | Verifying that the Gravity Calibration is effective over multiple start-up /<br>shut down cycles |
| Work Volume and Floor<br>Grid Verification | Verifying the design and functionality of the Work Volume and Floor<br>Grid features in the application software. |
| Accuracy Verification:<br>Patient Tracker | The Patient Tracker was evaluated for accuracy per ASTM F2554. |
| Guidance Arm Accuracy /<br>Repeatability | The positional accuracy of the Guidance Arm was evaluated by<br>collecting 27 data points in spaces within two work volumes (54 total<br>points) against a calibrated CMM. |
| Communication Rate<br>Verification | Force-Torque (F/T) Sensor to Control Software, Patient Tracker to<br>Control Software, Guidance Arm to Control Software and<br>communication between Application Software and Control Software<br>rates were evaluated for appropriate speed. |
| Verification / Validation<br>Type | Description |
| End User Calibration<br>Verification | Dimensional analysis and verification of Calibration Materials<br>(Calibration Drill Bit and Calibration End Effector Divot) |
| F/T Sensor Verification | Guidance Arm speed limit testing and drift / idle F/T Sensor<br>verification, intended to evaluate safety mitigations for Guidance Arm<br>motion. |
| Start-Up / Shutdown<br>Process Verification | Qualitative evaluation of all start-up / shutdown steps performed in a<br>simulated clinical environment. |
| Start-Up Joint Position<br>Identification | Verification to ensure system integrity of Guidance Arm in case any<br>joint motion that may have occurred while system was not powered. |
| User Emergency Safety<br>Verification | Evaluation of time required for a Guidance Arm emergency shutdown,<br>and emergency disconnection of the patient. |
| Guidance Arm Adjustment<br>to Patient Motion | Simulation of Patient Tracker motion while system is in Drill Mode, and<br>drill bit is in simulated bone block |
| Work Volume Verification | Assessment of physical design and cable management throughout<br>available work volumes. |
| Speed Trap Verification | Evaluation of the Guidance Arm and Patient Tracker speed trap safety<br>mitigations. |
| End User Validation of<br>User Requirements | Validation of User Requirements as they pertain to NGS Design and<br>Development, and Software Lifecycle Design and Development,<br>performed by End User in simulated environment. |
| End User Validation of<br>User Requirements for<br>Splint Application and<br>Removal | An addendum to the NGS End User Validation to repeat validation<br>steps associated with changes made to the design and instructions for<br>the use of the NGS Splint. |
| End User Validation of<br>User Requirements for<br>Changes made to Patient<br>Tracker End Effector | An addendum to the NGS End User Validation to repeat validation<br>steps associated with changes made to the design, and procedural<br>steps associated with the Patient Tracker End Effector |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in yellow. Above the word is a gray horizontal line, and to the right of the word is a gray crosshair symbol. The logo is simple and modern.

Table 3: Summary of all software and system verification and validation.

Nonclinical Comparisons to Predicate Device

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends slightly beyond the letters on either side. A gray crosshair-like symbol is positioned above the "i" in "neocis," with a small circle at the intersection of the lines.

Hardware and software verification and validation testing has been performed at the component and system level to confirm the performance of the NGS and assess substantial equivalence to the predicate device. Verification tests included:

- . Patient Splint attachment, stability, and removal testing
- . Total system use testing

Nonclinical validation testing was conducted in a simulated clinical environment and included full use of the system through the complete workflow. Testing demonstrated that the device is substantially equivalent to the predicate device.

## Clinical Testing

Clinical testing has been conducted to assess the application and removal of the Chairside Splint, with a primary focus on human factors issues. The study included objective criteria and subjective criteria evaluated by 15 dentists at two different sites over a total of 75 subjects. The investigator population included a variety of experience levels and the subject population included both upper and lower jaw testing.

The primary study endpoint was:

- Evaluation of human factors regarding Chairside Splint application and removal ●
It was evaluated using the following criteria and data:

- . Duration of Chairside Splint application and removal
- Photos and intra-oral scans of the site before and after Chairside Splint placement ●
- Occurrence of adverse events related to acrylic fixation
- Occurrence of adverse events during removal due to drilling the Chairside Splint .
- Occurrence of adverse events due to debris or other swallowing or aspiration potential ● hazards
- . Subjective evaluation by Investigators

Study results support the substantial equivalence of the NGS Chairside Splint to the cleared Patient Splint.

No significant adverse events or complications have been reported. In comparison to the predicate device, no significant new issues or risks have been identified.

## Conclusion:

The nonclinical and clinical testing demonstrated that the modified splint is substantially equivalent to the predicate device splint when used as intended.