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 quides surgeons during dental implant surgery (see Table 1 below for significant physical and performance characteristics details). 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 quidance 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 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 guidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's judgment. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Neocis Guidance System (NGS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies performance characteristics as acceptance criteria and also states a clinical study result.

Acceptance Criteria (Technological Characteristic)	Reported Device Performance (as stated in the document)
System Lateral Accuracy: RMS < 1 mm	RMS < 1mm (stated under "Overall System Accuracy (RMS)" in comparison table, and "accuracy with RMS error < 1mm" in clinical results)
System Depth Accuracy: RMS < 1 mm	RMS < 1mm (stated under "Overall System Accuracy (RMS)" in comparison table, and "accuracy with RMS error < 1mm" in clinical results)
System Angular Accuracy: RMS < 6.0°	Not explicitly re-stated as achieved, but the overall system accuracy <1mm suggests it was met or considered acceptable.
Quality of the osteotomy	Feasible and accurate (clinical test result)
Accuracy of the osteotomy relative to the pre-operative plan as measured in pre- and post-operative CT scans	Enables surgeons to achieve implant accuracy with RMS error < 1mm (clinical test result)
Feasibility of NGS use with regard to human factors issues	Feasible (clinical test result)
Duration for set-up (evaluated in clinical study)	Not specified (evaluated, but no specific performance metric reported in this summary)
Duration for osteotomy preparation (evaluated in clinical study)	Not specified (evaluated, but no specific performance metric reported in this summary)
Splint stability evaluation during surgery (evaluated in clinical study)	Not specified (evaluated, but no specific performance metric reported in this summary)
System deactivation due to patient motion (evaluated in clinical study)	Not specified (evaluated, but no specific performance metric reported in this summary)

Note: The document refers to "overall system accuracy (RMS) <1mm" in the comparison table and clinical results, encompassing lateral and depth accuracy, and implicitly angular accuracy.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 17 implants placed in 15 patients.
Data Provenance: The document states "Clinical testing has been conducted...at three different surgical sites." It does not specify the country of origin, but generally FDA submissions imply studies conducted or accepted within the US or under comparable regulatory frameworks. The study was prospective as it involved clinical testing with patients.

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

Number of Experts: Three surgeons.
Qualifications: No specific additional qualifications (e.g., years of experience, specific sub-specialty) beyond being "surgeons" were provided in this document.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth from multiple experts for the test set. The clinical study involved three surgeons, but the method for reconciling their assessments or determining a single ground truth is not detailed (e.g., whether it was based on consensus, majority rule, or if each surgeon's assessment of their own patient was considered ground truth).

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The clinical study focused on the feasibility and accuracy of the NGS for osteotomy preparation by surgeons using the system. It did not compare human performance with and without the device.

6. Standalone Performance Study

Yes, a standalone performance study was done for several components and the total system. The "Non-clinical Testing" section and "Software and System Verification and Validation" section describe various tests. Specifically:

Accuracy Verification: Patient Tracker: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
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..."
Guidance Arm Accuracy / Repeatability: "The positional accuracy of the Guidance Arm was evaluated by collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM."

These indicate individual component and system-level performance evaluations without direct human interaction as part of the performance metric itself, but rather evaluating the system's inherent accuracy.

7. Type of Ground Truth Used

For accuracy verification in non-clinical testing: Calibrated CMM (Coordinate Measuring Machine) for Guidance Arm, and likely precise measurements from the typodont for total system accuracy, and ASTM F2554 standards for Patient Tracker.
For clinical testing: Pre- and post-operative CT scans were used to measure the accuracy of the osteotomy relative to the pre-operative plan. The subjective criteria were based on the surgeons' evaluations (Likert scale surveys).

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. It largely focuses on the verification and validation of the device and its accuracy. As a surgical guidance system, its "training" often refers to the development and refinement of its algorithms and mechanical components rather than a machine learning training dataset.

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

As noted above, specific details about a "training set" and its ground truth establishment are not provided in this regulatory summary. The device's development likely involved engineering specifications, simulations, and iterative testing rather than a large-scale data-driven machine learning training approach with independently established ground truth labels in the conventional sense. The "Software and System Verification and Validation" section outlines various tests, but these are verification and validation steps, not training data generation.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single, flowing shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

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

Re: K161399

Trade/Device Name: Neocis Guidance System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 30, 2016 Received: December 1, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -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) K161399

Device Name Neocis Guidance System

Indications for Use (Describe)

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}------------------------------------------------

Image /page/3/Picture/0 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. A gray line extends horizontally above the word, and a vertical line intersects it at the right end of the word, forming a crosshair-like symbol. A small circle is present at the intersection of the lines.

Section 7. 510(k) Summary

Submitter Name:	Neocis Inc.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: 1-855-9NEOCIS
Contact Person:	Alon Mozes, Ph.D.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: (305) 409-2819
Date Prepared:	December 20, 2016
Trade Name:	Neocis Guidance System (NGS)
Common Name:	Dental Stereotaxic Instrument
Classification Name:	Bone cutting instrument and accessories (21 CFR 872.4120)
Classification:	Class II
Product Code:	PLV

Predicate Device: X-Guide® Surgical Navigation System (K150222) as primary predicate, IGI System (K023424) as reference device

Indications for Use:

Device Description:

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

Image /page/4/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in lowercase letters, with the "neo" part in a yellow-gold color and the "cis" part in a light gray color. Above the word is a horizontal gray line that extends over the "neo" part of the word. The "cis" part of the word has a gray circle above it, with a vertical gray line extending upwards and horizontal gray lines extending to the left and right.

Technological Characteristic	Neocis Guidance System
Supply Voltage	120 V
Phases	1
Type of Current	AC
Rated Frequency (Hz)	60 Hz
Rated Power Input (VA)	600 VA
Types and Ratings of externalaccessible fuses	5.0 A for 240 V
Type of Protection against ElectricShock	Class I Equipment

{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 yellow-gold color. Above the word is a gray horizontal line that extends over the "neo" portion of the word. A gray vertical line intersects the horizontal line above the "c" in "neocis", forming a plus sign with a small circle in the center.

Degree of Protection against ElectricShock	Type BF
Equipment Suitable for use in thepresence of Flammable Mixtures?	No
Mode of Operation	Continuous Operation
System Lateral Accuracy	RMS < 1 mm
System Depth Accuracy	RMS < 1 mm
System Angular Accuracy	RMS < 6.0°
CT Scan Quality Requirements	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full13cm 21 sec, Multi 2 DICOM format.
F/T Sensor Force Measurement Range	+/- 30 N
F/T Sensor TorqueMeasurement Range	+/- 2 Nm
F/T Sensor Single Axis Force OverloadLimit	200 N
F/T Sensor Single Axis TorqueOverload Limit	20 Nm
Upper limit specification for GuidanceArm Translation Speed	1.25 m/s
Storage Requirements	Store powered at Room Temperature (68°F to 76°F or 20°C to24.4°C) and standard ambient humidity (5% to 95%) in a dustfree, clean environment.

Table 1: Significant physical and performance characteristics of the NGS

Comparison of Technological Characteristics:

Both the subject and predicate systems provide accurate guidance of surgical tools and implantable devices through the use of computer-aided navigation. This guidance is achieved through the tracking of the surgical tools. 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.

Additionally, Neocis Guidance System and the predicate device share several other significant features:

Both devices have the same Intended Use. .
Both devices provide animated indicators to show the real time location of the surgical . tool relative to the patient anatomy, showing the tool in the patient CT in real time.
Both devices share identical specified environments of use. .
Both devices provide planning software allowing for placement of implant, target surgical . site, and guidance to the implant site.

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

Image /page/6/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, and to the right of the word is a gray crosshair symbol.

Both devices provide sub-millimeter guidance accuracy. ●
. Both devices use CT Scans for registration of the patient tracking attachment, for use in planning the desired implant location, and as a reference to determine the exact positioning of the surgical tools during the surgical procedure.

There are many similarities between the Neocis Guidance System and X-Guide, however there are also some differences (see Table 2 below for detailed comparison).

The two systems use different tracking methods. X-Guide utilizes LED camera tracking, whereas the Neocis Guidance System uses mechanical tracking. The mechanical tracker eliminates the risk of line-of-sight failures in optical tracking when stereoscopic cameras fail to see the markers on the patient or the surgical tool.

In addition to visual feedback, the Neocis Guidance System also provides physical guidance via the Guidance Arm, which grips the drill and provides constraints to limit the surgeon's motion to match the pre-operative plan. X-Guide only provides visual feedback, which does not physically prevent the surgeon from deviating from the plan.

TechnologicalCharacteristics	NGS (K161399)Subject Device	X-Guide (K150222)Predicate Device	IGI-System (K023424)Reference Device	Justification ofDifferences
Use Specifications
Indications forUse	The NeocisGuidance System(NGS) is acomputerizednavigational systemintended to provideassistance in boththe planning (pre-operative) and thesurgical (intra-operative) phasesof dentalimplantationsurgery. Thesystem providessoftware topreoperatively plandental surgicalprocedures andprovidesnavigationalguidance of thesurgicalinstruments.	The X-Guide® SurgicalNavigation System is acomputerizednavigational systemintended to provideassistance in both thepreoperative planningphase and the intra-operative surgicalphase of dentalimplantationprocedures. Thesystem providessoftware topreoperatively plandental surgicalprocedures andprovides navigationalguidance of thesurgical instruments.The device is intendedfor use for partiallyedentulous andedentulous adult andgeriatric patients whoneed dental implants	The Image-GuidedImplantation (IGI)System is acomputerizednavigational systemintended to provideassistance in both theplanning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationprocedure. The systemprovides accuratenavigational guidanceof surgical instruments,with regard to thepreoperative planningin dental implantationprocedure. The deviceis intended for use forpartially or fullyendentulous patientswho need dentalimplants as part oftheir treatment plan.	No significantdifference
TechnologicalCharacteristics	NGS (K161399)	X-Guide (K150222)	IGI-System (K023424)	Justification ofDifferences
	Subject Device	Predicate Device	Reference Device
		as part of theirtreatment plan
Technology / Performance Characteristics
Use Environment	Clinical Setting,Doctors Office	Clinical Setting,Doctor's Office	Clinical Setting,Doctor's Office	No difference
OperatingTemperature	10 - 35 deg C	10 - 35 deg C	Not Specified	Both systems areintended for use insimilar clinicalenvironments.
OperatingRelative Humidity	5-95%	30% - 90% non-condensing	Not Specified	Both systems areintended for use insimilar clinicalenvironments.
Altitude	500 hPa-1060hPa	500 hPa-1060hPa	500 hPa-1060hPa	No difference
TransportTemperature	0°C to 46°C	-20 - +60 deg C	0 - 40 deg C	No significantdifference
TransportHumidity	5-95%	10% - 95% non-condensing	10% - 80% non-condensing	No significantdifference
Optical Radiation	N/A	LED, Risk Group 1(minimal risk) per IEC62471-1	Laser, Class II (<1mW)per IEC 60825-1, 620-690 nm	NGS has no riskrelated to opticalradiation
TrackingTechnology	MechanicalTracking	Stereo Cameras /LEDs / Pattern	Stereo Cameras /Infrared LEDs	Mechanical trackingprovides analternative trackingmethod that avoidsline-of-sightchallenges causedby optical tracking.
CalibrationFrequency	Prior to eachsurgery	Prior to each surgery	Factory Calibrated andauthorized servicepersonnel	No difference
Overall SystemAccuracy (RMS)	<1mm	<1mm	<1mm	No difference
Alarms	Audible, Visual	Audible, Visual	Audible, Visual	No difference
Monitor	LCD-TFT	LCD-TFT	LCD-TFT	No difference
TechnologicalCharacteristics	NGS (K161399)Subject Device	X-Guide (K150222)Predicate Device	IGI-System (K023424)Reference Device	Justification ofDifferences
CommunicationsInterface	Ethernet	Ethernet	Ethernet	No difference
Software	NavigationalGuidance andImplant Planning	Navigational Guidanceand Implant Planning	Navigational Guidanceand Implant Planning	No difference
Dimensions	Height: 73 in(1854.2 mm)Width: 64 in(1625.6 mm)Depth: 34 in (863mm)	Height: 64.653 in(1642.19 mm) Width:21.011 in (533.67mm)	Unavailable	Both systems areintended for use insimilar clinicalenvironments andare classified asmobile per IEC / EN60601-1definition.
MountingConfiguration	Mobile Cart	Mobile Cart	Mobile Cart	No difference
Weight	427lbs. (194 kg)	130lbs. (58.97 kg)	Unavailable	Both systems areclassified as Mobile,per IEC / EN 60601-1 definition.Differences in weightthat may exist do notaffect either device'sefficacy or intendeduse.
Safety Features
Electrical Safety	Compliance withthe following: IEC60601-1:2005 +Corr. 1 (2006) +Corr. 2 (2007)ANSI/AAMIES60601-1:2005®2012 andC1:2009/® 2012and A2:2010/®2012 (ConsolidatedText) MedicalElectricalEquipment - Part1: GeneralRequirements forBasic Safety and	IEC 60601-1:2005 3rdEdition AAMIES60601-1:2005+A1:2009 +A2:2010EN 60601-1:2006ISO15223-1:2012BS EN ISO14971:2012	Compliance with thefollowing: EN60601-1:1990 +A1:1992+A2: 1995; +A13IEC 601-1:1998+A1:1991+A2:1995+CorrigendumEN60601-1-1:1993+A1:1995IEC60601-1-4:1996	Both systems havebeen tested toequivalentstandards.
TechnologicalCharacteristics	NGS (K161399)Subject Device	X-Guide (K150222)Predicate Device	IGI-System (K023424)Reference Device	Justification ofDifferences
	EssentialPerformance.		EN980:1996 +A1:1999
	ISO15223-1:2012		EN1441:1997
	BS EN ISO14971:2012

ElectromagneticCompatibility	Compliance withIEC 60601-1-2:2007	IEC 60601-1-2:20073rd Edition	EN 60601-1-2:1993IEC 601-2:1993	No difference
Biocompatibility	Yes (ISO 10993-1,-5, -10, -11, - 12)	Yes (ISO 10993-1, -5,-10, -11, - 12)	not specified	No difference
Sterilization	Steam	Steam	Steam	No difference
Disinfectant (High-Level)	N/A	3% Glutaraldehydesolution	3% Glutaraldehydesolution	NGS does not useany high-leveldisinfection.
Ingress Protection	IPX0	IPX2	Not Specified	Both systems areintended for use insimilar clinicalenvironments. NGShas drapes foradditional ingressprotection.
Energy
Mains Voltage,Frequency	120 VAC; 50 / 60Hz	100 - 127VAC / 200 -240VAC ; 50 / 60 Hz	100 - 127VAC / 200 -240VAC ; 50 / 60 Hz	No significantdifference
Input Power(VA)	600 VA	1500VA	260VA	No significantdifference
Fusing Type /Rating	5.0 A for 240 V	Circuit Breaker: 100-127VAC, 10A	Fuse: Qty 2 @ 6A/100-120VAC	Both componentsperform the samefunction. The NGSuses a 5.0 A fuse toaccommodate a loadspecific to devicecomponents
Technological	NGS (K161399)	X-Guide (K150222)	IGI-System (K023424)	Justification of
Characteristics	Subject Device	Predicate Device	Reference Device	Differences
Degree ofProtection AgainstElectrical Shock	Applied PartType BF	Applied Part Type B	Applied Part Type BF	The applied part(Patient Splint) isfloating since thereis an insulator on theend of the PatientTracker. However,since the appliedpart is mechanicallylinked to the system,the NGS is tested toa higher riskcategory (Type BF)for protectionagainst electricalshock.
Type of ProtectionAgainst ElectricalShock	Class I	Class I	Class I	No difference
Mode ofOperation	Continuous	Continuous	Continuous	No difference
Components
Bone Screw	N/A	Bone Screw	Bone Screw	No bone screwrequired for NGS
CT Registration	NGS Fiducial Array	X-Clip	Custom RegistrationDevice (CRD) And 3Point TouchRegistration Fixture	Intended use forthese items is thesame.
Patient TrackingDevice	Patient Tracker	X-Corner PatientTracker	Patient Tracker	Intended use forthese items is thesame.
Surgical ToolTracking Device	NGS GuidanceArm	X-Corner HandpieceTracker	Handpiece Tracker	The physicalguidance providedby the NGSGuidance Arm is anadditional safetyfeature to preventdeviations from theplan
Screwdriver	Yes	Yes	Yes	Intended use forthese items is thesame.
TechnologicalCharacteristics	NGS (K161399)Subject Device	X-Guide (K150222)Predicate Device	IGI-System (K023424)Reference Device	Justification ofDifferences
Patient TrackingAttachmentSystem	Splint	E-Clip	Splint	Intended use forthese items is thesame.
Drill Bit LengthDetermination	Depth Gauge andOperator Entry	Go Button	Operator Entryrequired	Intended use forthese items is thesame.
Patient TrackerAttachment Arms	Patient Tracker	Posterior Tracker ArmAnterior Tracker Arm	6 Poles - 3 Upper, 3Lower	Intended use forthese items is thesame.

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

Image /page/7/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the "i" is a thin gray line with a circle at the end, resembling a target. Below the logo are two text boxes, one containing "X-Guide (K150222)" and the other containing "IGI".

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

Image /page/8/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the "i" is a thin gray line with a circle at the end, resembling a target. Below the logo are two text boxes, one containing "X-Guide (K150222)" and the other containing "IGI".

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

Image /page/9/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a light orange color. Above the "i" in "neocis" is a thin gray line with a small circle at the end.

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

Image /page/10/Picture/0 description: The image shows the word "neocis" in a stylized font. The letters are connected by a horizontal line above them. There is a small circle with a vertical line extending from it to the horizontal line above the letters.

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

Image /page/11/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the "neo" portion in a golden color and the "cis" portion in a gray color. Above the word is a gray line that extends horizontally, and to the right of the word is a gray line that extends vertically, intersecting at a small circle.

Table 2: Summary of Technological Characteristics Comparison

Performance Testing:

Non-clinical Testing:

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

{12}------------------------------------------------

Image /page/12/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 gold color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically. The two lines intersect at a small gray circle above the "i" in "neocis."

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 Lifecvcle 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)
· 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 / ValidationType	Description
Simulated Use	Run through of Typical Use Case
Boundary Condition	Testing of all potential boundary parameters in the ApplicationSoftware
Registration	Testing of registration process
Case File Contents	Simulated use testing of features associated with saving / loadingCases
Error Case Injection	Simulating all error messages and pop-ups.
CT Scan Verification	Verification of the resolution and validity of CT Scans
Control SW BoundaryCondition Testing	Testing the mechanical boundaries of the Control Software andGuidance Arm.
Control Software GravityCalibration Verification	Verifying that the Gravity Calibration is effective over multiple start-up /shut down cycles
Work Volume and FloorGrid Verification	Verifying the design and functionality of the Work Volume and FloorGrid features in the application software.
Accuracy Verification:Patient Tracker	The Patient Tracker was evaluated for accuracy per ASTM F2554.
Verification / ValidationType	Description
Total System Accuracy	The Total System was evaluated for accuracy via simulated use with atypodont as simulation of a patient with three osteotomies per typodontin four locations (Upper Right / Upper Left / Lower Right / Lower Left).
Guidance Arm Accuracy /Repeatability	The positional accuracy of the Guidance Arm was evaluated bycollecting 27 data points in spaces within two work volumes (54 totalpoints) against a calibrated CMM.
Communication RateVerification	Force-Torque (F/T) Sensor to Control Software, Patient Tracker toControl Software, Guidance Arm to Control Software andcommunication between Application Software and Control Softwarerates were evaluated for appropriate speed.
End User CalibrationVerification	Dimensional analysis and verification of Calibration Materials(Calibration Drill Bit and Calibration End Effector Divot)
F/T Sensor Verification	Guidance Arm speed limit testing and drift / idle F/T Sensorverification, intended to evaluate safety mitigations for Guidance Armmotion.
Patient Tracker and SplintMounting Verifications	Evaluating the effect of 2x Patient Tracker weight as total downwardforce on a standard splint mounted on a typodont per the IFU. Inaddition, evaluation of kinematic mount repeatability and patientanatomy accommodation analysis.
Start-Up / ShutdownProcess Verification	Qualitative evaluation of all start-up / shutdown steps performed in asimulated clinical environment.
Start-Up Joint Positionldentification	Verification to ensure system integrity of Guidance Arm in case anyjoint motion that may have occurred while system was not powered.
User Emergency SafetyVerification	Evaluation of time required for a Guidance Arm emergency shutdown,and emergency disconnection of the patient.
Guidance Arm Adjustmentto Patient Motion	Simulation of Patient Tracker motion while system is in Drill Mode, anddrill bit is in simulated bone block
Work Volume Verification	Assessment of physical design and cable management throughoutavailable work volumes.
Speed Trap Verification	Evaluation of the Guidance Arm and Patient Tracker speed trap safetymitigations.
Verification / ValidationType	Description
End User Validation ofUser Requirements	Validation of User Requirements as they pertain to NGS Design andDevelopment, and Software Lifecycle Design and Development,performed by End User in simulated environment.
End User Validation ofUser Requirements forSplint Application andRemoval	An addendum to the NGS End User Validation to repeat validationsteps associated with changes made to the design and instructions forthe use of the NGS Splint.
End User Validation ofUser Requirements forChanges made to PatientTracker End Effector	An addendum to the NGS End User Validation to repeat validationsteps associated with changes made to the design, and proceduralsteps associated with the Patient Tracker End Effector

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the word "neocis" in a stylized font. The word is in a golden color. Above the word is a gray line with a circle in the middle and a vertical line extending upwards from the circle.

{14}------------------------------------------------

Image /page/14/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 yellow. Above the word is a gray horizontal line, and to the right of the word is a gray vertical line with a circle at the intersection of the two lines. The logo is simple and modern.

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

Non-clinical Comparisons to Predicate Device:

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 claims to the predicate device. Verification tests included:

Accuracy testing for the Patient Tracker, Guidance Arm, and full system ●
Communication rate verification ●
. Calibration testing
. Emergency use

Internal 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 accuracy, usability, and performance of the NGS, with a primary focus on human factors issues. The study included objective (performance) criteria and subjective (qualitative) criteria evaluated by three surgeons at three different surgical sites over a total of 17 implants placed in 15 patient population included male and female patients with upper and lower jaw implant requirements.

The primary endpoint was:

Feasibility of NGS use with regard to human factors issues .
It was evaluated using the following criteria:
Subjective evaluation in a survey using the Likert scale ●
Duration for set-up ●
Duration for osteotomy preparation .
. Splint stability evaluation during surgery

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the "neo" portion in gray and the "cis" portion in yellow. Above the word is a gray line that extends horizontally, with a small circle in the middle. A vertical line extends from the circle upwards, creating a cross-like shape.

. System deactivation due to patient motion
The secondary endpoint was:

Feasibility and accuracy of osteotomy preparation using the NGS .

It was evaluated using the following criteria:

Quality of the osteotomy .
Accuracy of the osteotomy relative to the pre-operative plan as measured in pre- and . post-operative CT scans

Clinical test results show that use of the NGS is feasible and accurate. The results demonstrated that the NGS enables surgeons to achieve implant accuracy with RMS error < 1mm.

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

Conclusion:

The non-clinical and clinical testing demonstrate that the NGS is substantially equivalent to its predicate device when used as intended.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.