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 guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The implant process occurs in two phases: planning and surgical. Physical guidance is provided via the Guidance Arm. Visual guidance is provided by 3D graphics and 2D cross sections. The patient tracking portion is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth and has a fiducial array. The Patient Tracker is a mechanical feedback system connected to the Patient Splint. Calibration and measurement steps are required using the Calibration Drill Bit and Depth Gauge. The NGS is a supporting device and does not replace the surgeon's judgment. The subject device is the same as the predicate device (K173402) except for a change to the dental materials used to affix the splint.

AI/ML Overview

This document describes the Neocis Guidance System (NGS) and its equivalence to a previously cleared predicate device (K173402), specifically focusing on the modification of dental materials used to affix the chairside patient splint.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for system accuracy (lateral, depth, and angular) and the reported performance for the Neocis Guidance System (NGS) are provided below. These criteria and performance values were established for the predicate device (K173402) and are stated to be unchanged for the subject device.

Acceptance Criterion	Reported Device Performance
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, Full 13cm 21 sec, Multi 2 DICOM format
F/T Sensor Force Measurement Range	+/- 30 N
F/T Sensor Torque Measurement Range	+/- 2 Nm
F/T Sensor Single Axis Force Overload Limit	200 N
F/T Sensor Single Axis Torque Overload Limit	20 Nm
Upper limit specification for Guidance Arm Translation Speed	1.25 m/s

Study Proving Device Meets Acceptance Criteria:

The current submission (K182776) focuses on demonstrating substantial equivalence for the modified dental materials used to affix the chairside patient splint. It relies on performance testing previously performed on the predicate NGS (K161399 and K173402) for the overall system accuracy and other technical characteristics. The document explicitly states: "The subject of this 510(k) was only a modification to the dental materials used to affix the chairside patient splint. As such, non-clinical testing performed in support of clearance of the predicate NGS itself did not need to be repeated."

Therefore, the studies verifying the system accuracy parameters listed above were conducted on the predicate device (K161399 and K173402). The specific details of these studies are summarized below from the provided text for both the predicate device and the new material validation:

For the Predicate Device's Overall System Accuracy (K173402 and K161399):
- 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 Accuracy: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
- 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."
For the Substantial Equivalence of New Dental Materials (K182776):
- Material polymerization temperature measurements: Splints were affixed to typodonts using the new dental materials in a heat box at 37°C. Curing temperature was measured with a thermocouple, and maximum temperatures were reported.
- Rigidly mounted splint deflection measurement: Splints were mounted to typodonts using the new dental materials, and a load 2-times the weight of the Patient tracker was applied. Deflection was measured at various points using a FARO arm. Mean deflection with standard deviation was reported.
- Comparison of materials' material safety data sheets (MSDS): MSDS sheets were compared to assess material compositions and safety hazards.
- Simulated clinical use validation: Surgeons affixed and removed chairside patient splints from typodonts using the new dental materials. Qualitative validation and usability endpoints were recorded.

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

Due to the nature of this 510(k) submission which focuses on a material change and relies heavily on previous clearances for system performance, specific sample sizes for all test sets are not exhaustively detailed for this current submission.

Predicate Device (K173402/K161399) Studies (for overall system accuracy):
- Total System Accuracy: 1 typodont (with 3 osteotomies per typodont in 4 locations). The data provenance is implied to be from laboratory testing/simulated use, likely in the US (where Neocis Inc. is located).
- Patient Tracker Accuracy: "evaluated for accuracy per ASTM F2554" - specific sample size not provided, but implies standard testing methods. Data provenance is implied to be laboratory testing.
- Guidance Arm Accuracy / Repeatability: 27 data points in spaces within two work volumes (total 54 points). Data provenance is implied to be laboratory testing.
Current Submission (K182776) Studies (for new dental materials):
- No specific sample sizes (e.g., number of typodonts, number of splints tested) are provided for the material polymerization, deflection measurement, or the simulated clinical use validation. The format "Splints were affixed to typodonts..." suggests multiple instances, but the exact number isn't quantified. The data provenance is implied to be from laboratory testing/simulated use, likely in the US.

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

For the Predicate Device's Overall System Accuracy (K173402/K161399):
- Simulated Use (End User Validation): "Run through of typical splint affixation cases using typodonts, performed by Surgeons." The number of surgeons is not specified. Their qualifications are listed generally as "Surgeons" (implying dental surgeons relevant to the device's indications for use), but specific experience years are not provided.
- End User Validation of User Requirements: "Validation of User Requirements as they pertain to NGS Design and Development, and Software Lifecycle Design and Development, performed by End User in simulated environment." "End Users" would typically be dental surgeons, but their specific number and qualifications are not detailed.
For the Current Submission (K182776) Studies (for new dental materials):
- Simulated clinical use validation: "Surgeons affixed and removed chairside patient splints from typodonts using the dental materials specified in this submission." The number of surgeons is not specified, nor are their specific qualifications beyond "Surgeons."

4. Adjudication Method for the Test Set

The provided text does not explicitly describe an adjudication method (like 2+1, 3+1). The tests appear to be primarily quantitative measurements (accuracy, deflection, temperature) or qualitative assessments of usability ("qualitative validation and usability endpoints were recorded" for simulated clinical use), where consensus or adjudication processes are not typically applied in the same way as, for example, expert review of images.

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

No MRMC comparative effectiveness study is mentioned, nor is an effect size for human readers improving with AI vs. without AI assistance. This device is a robotic guidance system, not an AI-assisted diagnostic imaging tool that would typically involve human reader studies. It guides the surgeon during the procedure rather than providing diagnostic information.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) was done for various components and overall system accuracy, as implied by the non-clinical testing performed on the predicate device. Examples include:

Total System Accuracy: "The Total System was evaluated for accuracy via simulated use with a typodont..."
Patient Tracker Accuracy: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
Guidance Arm Accuracy / Repeatability: Positional accuracy evaluated against a calibrated CMM.
Measurements of "material polymerization temperature" and "rigidly mounted splint deflection" for the new materials are also forms of standalone, objective measurements.

7. Type of Ground Truth Used

The ground truth used primarily consists of objective physical measurements from calibrated instruments and established standards.

For system accuracy, it would be the precisely known positions and angles within a calibrated test setup (e.g., against a CMM for Guidance Arm accuracy, or the planned osteotomy sites in a typodont for total system accuracy).
For the new materials, ground truth involved direct measurements of temperature and deflection using instruments like thermocouples and FARO arms.
For usability, the "ground truth" is a qualitative assessment by surgeons during simulated use.

8. Sample Size for the Training Set

No information regarding a "training set" or "training data" is provided. This device is a robotic guidance system, not a machine learning or AI algorithm that typically would have a distinct training phase requiring a training set in the conventional sense. The "software and system verification and validation" (Table 3) describes comprehensive testing of software functions and system boundaries, but these are verification/validation activities, not "training."

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

As no training set is mentioned for the device's functionality, this question is not applicable based on the provided document. The device's operation is based on pre-programmed guidance and real-time tracking, not on a learned model derived from a training dataset.

Summary

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December 21, 2018

Neocis Inc. Thomas Claiborne, Ph.D. Regulatory Affairs Manager 555 NW 29th Street Miami, Florida 33127

Re: K182776

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: December 3, 2018 Received: December 4, 2018

Dear Thomas Claiborne:

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/cdrl/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.

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.12.21
2018-05-09 09:51:12 -05'00'

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)	K182776
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)

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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. A gray horizontal line extends from the left of the word to above the "neo" portion. A gray vertical line extends from above the "cis" portion, intersecting with the horizontal line at a small circle.

510(k) Summary

Submitter Name:	Neocis Inc.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: 1-855-9NEOCIS
Contact Person:	Thomas Claiborne, Ph.D.2800 Biscayne Blvd.Suite 600Miami, FL 33137Tel: 1-855-9NEOCIS
Date Prepared:	December 20, 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 (NGS) with Chairside Splint (K173402)

Indications for Use:

Device Description:

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

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Image /page/4/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in gold. A gray line is above the word, and a gray crosshair is to the right of the word. The crosshair has a small circle in the center.

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 quidance 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.

The subject device is the same as the NGS cleared under K173402 (the predicate device). except for a change to the dental materials used to affix the 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 dental materials specified in this submission. 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.

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Image /page/5/Picture/1 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. 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 "c" in "neocis."

Comparison of Technological Characteristics:

This submission involves only a modification to the dental materials for use with the chairside patient splint. Otherwise, all performance characteristics of the NGS are the same. The differences introduced by this modification are detailed in Table 1.

Technological	NGS with Chairside Splint	NGS with Chairside Splint	Comments
Characteristics	Subject Device	Predicate Device (K173402)
Indications for Use
Indications forUse	The Neocis Guidance System(NGS) is a computerizednavigational system intendedto provide assistance in boththe planning (pre-operative)and the surgical (intra-operative) phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments.	The Neocis Guidance System(NGS) is a computerizednavigational system intendedto provide assistance in boththe planning (pre-operative)and the surgical (intra-operative) phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments.	No difference
Materials
Materials	Ixef®-HC-1022	Ixef®-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(Hz)	60 Hz	60 Hz	No difference
Rated PowerInput (VA)	600 VA	600 VA	No difference
Types andRatings ofexternalaccessible fuses	5.0 A for 240 V	5.0 A for 240 V	No difference
Type of Protectionagainst ElectricShock	Class I Equipment	Class I Equipment	No difference
Degree ofProtection againstElectric Shock	Type BF	Type BF	No difference
TechnologicalCharacteristics	NGS with Chairside Splint	NGS with Chairside Splint
	Subject Device	Predicate Device (K173402)	Comments
EquipmentSuitable for use inthe presence ofFlammableMixtures?	No	No	No difference
Mode ofOperation	Continuous Operation	Continuous Operation	No difference
System LateralAccuracy	RMS < 1 mm	RMS < 1 mm	No difference
System DepthAccuracy	RMS < 1 mm	RMS < 1 mm	No difference
System AngularAccuracy	RMS < 6.0°	RMS < 6.0°	No difference
CT Scan QualityRequirements	0.3 mm Voxel, 0.3 mm SliceThickness, Matrix 512x512, Full13cm 21 sec, Multi 2 DICOMformat.	0.3 mm Voxel, 0.3 mm SliceThickness, Matrix 512x512, Full13cm 21 sec, Multi 2 DICOMformat.	No difference
F/T Sensor ForceMeasurementRange	+/- 30 N	+/- 30 N	No difference
F/T SensorTorqueMeasurement Range	+/- 2 Nm	+/- 2 Nm	No difference
F/T Sensor SingleAxis ForceOverload Limit	200 N	200 N	No difference
F/T Sensor SinaleAxis TorqueOverload Limit	20 Nm	20 Nm	No difference
Upper limitspecification forGuidance ArmTranslation Speed	1.25 m/s	1.25 m/s	No difference
StorageRequirements	Store powered at RoomTemperature (68°F to 76°F or20°C to 24.4°C) and standardambient humidity (5% to 95%) in adust free, clean environment.	Store powered at RoomTemperature (68°F to 76°F or20°C to 24.4°C) and standardambient humidity (5% to 95%) in adust free, clean environment.	No difference
Splint Attachment	Chairside Splint can be attachedchairside with use of acrylic ordeveloped with acrylic on a patientmodel in a dental lab.	Chairside Splint can beattached chairside with use ofacrylic or developed withacrylic on a patient model in adental lab.	No difference
Dental materials(acrylics or resins)	· Alike (K942670-GC PatternResin)· Cool Temp Natural (K041098)· 3M ESPE ProTemp Plus(K033022-Protemp 3 Garant)· Visalys Core (UV light curable)(K143104)· EZ Pickup (UV light curable)(K984341-SternVantageVarnish LC Model 221001)· Ufi Gel hard C (K030916)· Triad C&B Material (UV lightcurable) (K850911)	Lang Jet Tooth Shade(K083195)	Additional dentalmaterials meetperformancespecifications forthe chairsidesplint.
Splint Removal	Chairside Splint may be removedeither by cutting bridges along aseam of the splint or manuallypulling off.	Chairside Splint may beremoved either by cuttingbridges along a seam of thesplint or manually pullingoff.	No difference
Fiducial Array	The Fiducial Array attaches to the	The Fiducial Array attaches to the	No difference
Attachment to	splint during the CT scan to	splint during the CT scan to	No difference

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Image /page/6/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 a golden color and the "cis" portion in a lighter golden color. Above the word is a gray horizontal line that extends over the "neo" portion. Above the "i" in "cis" is a gray circle with a vertical line extending upwards and horizontal lines extending to the left and right.

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Image /page/7/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font, with the letters in a golden color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically, intersecting at a small circle above the "c" in "neocis".

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Image /page/8/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the "neo" portion in gold and the "cis" portion in gray. Above the word is a gray horizontal line that extends over the "neo" portion and connects to a circle above the "c" in "cis". A vertical line extends upward from the circle, creating a cross-like shape.

Technological	NGS with Chairside Splint	NGS with Chairside Splint	Comments
Characteristics	Subject Device	Predicate Device (K173402)
Splint	provide a reference in the image.	provide a reference in the image.
Kinematic MountAttachment toSplint	The Kinematic Mount attaches tothe splint to provide a mountingpoint for the Fiducial Array andPatient Tracker.	The Kinematic Mount attaches tothe splint to provide a mountingpoint for the Fiducial Array andPatient Tracker.	No difference
Splint Shape andKinematic MountLocation	The shape of the splint and thelocation of the Kinematic Mountattachment point are designed toallow for proper ergonomicapproach of the Patient Trackerand Guidance Arm.	The shape of the splint and thelocation of the Kinematic Mountattachment point are designed toallow for proper ergonomicapproach of the Patient Trackerand Guidance Arm.	No difference
Safety Features
Biocompatibility	Yes (ISO 10993-1, -5, -10, -11, -12)	Yes (ISO 10993-1, -5, -10, -11, -12)	No difference
Sterilization	Steam	Steam	No difference
Components
Patient TrackingDevice	Patient Tracker	Patient Tracker	No difference
Patient TrackingAttachmentSystem	Chairside Splint	Chairside Splint	No difference

Table 1: Summary of Technological Characteristics Comparison

Performance Testing:

Non-clinical Testing

Chairside Splint verification and validation testing from K173402 is described below in Table 2.

Verification / ValidationType	Description
Simulated Use (End UserValidation)	Run through of typical splint affixation cases using typodonts, performed bySurgeons.
Total System Accuracy	The Total System was evaluated for accuracy via simulated use with atypodont as simulation of a patient with three osteotomies per typodont infour locations (Upper Right / Upper Left / Lower Right / Lower Left).
Patient Tracker and SplintMounting Verifications	Evaluating the effect of 2x Patient Tracker weight as total downward forceon a standard splint mounted on a typodont per the IFU. In addition,evaluation of kinematic mount repeatability and patient anatomyaccommodation analysis.

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Image /page/9/Picture/1 description: The image shows the logo for "neocis". The word "neocis" is written in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends over the word. There is a gray circle with a vertical line extending above and below the circle, intersecting the horizontal line above the word.

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

The subject of this 510(k) was only a modification to the dental materials used to affix the chairside 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 previously performed on the NGS (K161399) 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)

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Image /page/10/Picture/1 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 lighter golden color. Above the word is a horizontal gray line that extends over the entire word. A gray vertical line intersects the horizontal line at the letter "o" in "neocis", forming a cross 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 / 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.
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.
Verification / ValidationType	Description
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.
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.
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

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

Nonclinical Comparisons to Predicate Device in this Submission

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We performed the following tests to establish substantial equivalence for chairside patient splint affixation using additional dental materials:

. Material polymerization temperature measurements
Splints were affixed to typodonts using the dental materials specified in this submission in a heat box set to 37°C. Curing temperature of the dental material was measured using a thermocouple. Maximum temperatures were reported.
. Rigidly mounted splint deflection measurement
Splints were mounted to typodonts using the dental materials specified in this submission then a load 2-times the weight of the Patient tracker was placed on the chairside patient splints. Deflection was measured at various points using a FARO arm. Mean defelction with standard deviation were reported.
Comparison of materials' material safety data sheets (MSDS) .
We compared the MSDS sheets to not material compositions and safety hazards. Each dental material was similar.
. Simulated clinical use validation (simulated clinical affixation and removal by surgeons)
Surgeons affixed and removed chairside patient splints from typodonts using the dental materials specified in this submission. Qualitative validation and usability endpoints were recorded.

Conclusion:

There are no technological changes to the NGS or chairside patient splint in this submission. There are no changes to the indications for use of the subject device in this submission. Our performance testing demonstrates substantially equivalent chairside patient splint performance when it is used with the specified additional dental materials. The nonclinical testing demonstrated that the modified splint is substantially equivalent to the predicate device splint 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.