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 quidance 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 decision- making process during the surgical procedure. It is not intended to replace the surgeon's judqment. 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 K182776 (the predicate device), except for a change to the dental drill supplier and dental drill collar design. The dental handpiece and motor have received previous 510(k) clearance under K070084 and K030163.

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 the labeling. 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.

AI/ML Overview

The provided text describes information about the Neocis Guidance System (NGS), a computerized navigational system for dental implantation surgery. However, the document (a 510(k) premarket notification) primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in dental drill supplier and collar design, rather than proving the device meets new acceptance criteria established for this specific submission.

Therefore, the information regarding acceptance criteria and study details is largely drawn from previous clearances (K173402 and K161399) as the current submission leverages prior performance testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" presented as a single, consolidated list with corresponding performance for the current submission (K191605). Instead, it refers to the performance characteristics of the device, which serve as criteria for substantial equivalence to the predicate. The "Prior Performance Testing" sections (K173402 and K161399) detail various verification and validation activities.

For this submission, the comparison table (Table 1) between the subject device and the predicate device outlines several technical characteristics. The implicit acceptance criterion for these is "no difference" compared to the predicate, as highlighted in the "Comments" column.

Acceptance Criteria (Derived from Predicate Device Performance)	Reported Device Performance (Subject Device)	Comments (from Table 1)
System Lateral Accuracy: RMS < 1 mm	RMS < 1 mm	No difference
System Depth Accuracy: RMS < 1 mm	RMS < 1 mm	No difference
System Angular Accuracy: RMS < 6.0°	RMS < 6.0°	No difference
CT Scan Quality Requirements: 0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full 13cm 21 sec, Multi 2 DICOM format.	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512x512, Full 13cm 21 sec, Multi 2 DICOM format.	No difference
F/T Sensor Force Measurement Range: +/- 30 N	+/- 30 N	No difference
F/T Sensor Torque Measurement Range: +/- 2 Nm	+/- 2 Nm	No difference
F/T Sensor Single Axis Force Overload Limit: 200 N	200 N	No difference
F/T Sensor Single Axis Torque Overload Limit: 20 Nm	20 Nm	No difference
Upper limit specification for Guidance Arm Translation Speed: 1.25 m/s	1.25 m/s	No difference
Biocompatibility: Yes (ISO 10993-1, -5, -10, -11, -12)	Yes (ISO 10993-1, -5, -10, -11, -12)	No difference
Sterilization: Steam	Steam	No difference

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides limited specific numbers for test set sample sizes and provenance:

Total System Accuracy (K173402): Evaluated with "a typodont as simulation of a patient with three osteotomies per typodont in four locations (Upper Right / Upper Left / Lower Right / Lower Left)." This implies multiple osteotomies on each typodont, but the exact number of typodonts is not specified.
Guidance Arm Accuracy / Repeatability (K161399): "collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM."
Other tests: Descriptions like "Run through of Typical Use Case," "Testing of all potential boundary parameters," and "Simulating all error messages and pop-ups" do not provide specific numerical sample sizes.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating "simulated use" on typodonts/in a simulated clinical environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Simulated Use (End User Validation) (K173402 and K161399): Performed by "Surgeons" (K173402) and "End User" (K161399). The number of surgeons/end users and their specific qualifications (e.g., years of experience, specialization) are not specified in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for establishing ground truth in the reported tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document refers to the Neocis Guidance System as a "computerized navigational system" and a "stereotaxic medical device that guides surgeons." It is a surgical guidance device, not an AI-powered diagnostic or interpretive tool that assists "human readers." Therefore, an MRMC comparative effectiveness study involving human readers (as typically seen in diagnostic imaging AI) is not applicable to this type of device, and no such study is mentioned. The system assists surgeons during the surgical procedure rather than enhancing their interpretation of images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is designed for human-in-the-loop operation, as it "guides surgeons" and "is not intended to replace the surgeon's judgment." The reported accuracy tests (System Lateral Accuracy, System Depth Accuracy, System Angular Accuracy, Guidance Arm Accuracy / Repeatability) likely represent the standalone technical performance of the guidance system's robotic/mechanical components, separate from the surgeon's manual actions, but within the context of a simulated surgical environment where the system provides guidance. The document does not explicitly present "standalone algorithm performance" in a way that separates algorithmic output from its interaction with the mechanical guidance system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the reported accuracy tests appears to be physical measurements against established benchmarks or calibrated equipment.

Total System Accuracy (K173402): Accuracy was evaluated, implying a comparison against a known, intended plan or precise measurements on the typodont.
Guidance Arm Accuracy / Repeatability (K161399): Evaluated "against a calibrated CMM" (Coordinate Measuring Machine), which provides highly accurate physical measurements.
End User Calibration Verification (K161399): "Dimensional analysis and verification of Calibration Materials."

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This type of surgical guidance system typically relies on computational geometry, kinematics, and control theory rather than machine learning models that require labeled training data in the same way as an AI diagnostic algorithm.

9. How the ground truth for the training set was established

Since no training set is mentioned for an AI/machine learning model, this question is not applicable. The device's functionality is based on established engineering principles and calibration processes.

Summary

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September 11, 2019

Neocis Inc. Thomas Claiborne Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K191605

Trade/Device Name: Neocis Guidance System (NGS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: PLV Dated: June 12, 2019 Received: June 17, 2019

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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, PhD Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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)	K191605
Device Name	Neocis Guidance System

Indications for Use (Describe)
--------------------------------

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the

Nocis 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)

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Submitter Name:

Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS

Contact Person:

Thomas Claiborne, Ph.D. 2800 Biscayne Blvd. Suite 600 Miami. FL 33137 Tel: 1-855-9NEOCIS

Date Prepared: September 11, 2019

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: Neocis Guidance System (NGS) with Chairside Splint (K182776)

Reference Devices: Aseptico VCT Versatile Control Technology Model AEU-925 (K030163), Montblanc Implantology Contra-angle Control (K070084), Neocis Guidance System (K161399), and Neocis Guidance System with Chairside Splint (K173402)

Indications for Use:

Device Description:

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and K030163.

Comparison of Technological Characteristics:

This submission involves a modification to the dental drill supplier and to the dental drill collar design. Otherwise, all performance characteristics of the NGS are the same. The differences introduced by this modification are detailed in the table 1 below.

Technological	NGS	NGS with Chairside Splint
Characteristics	Subject Device	Predicate Device (K182776)	Comments
Indications for Use
Indications forUse	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra- operative) phases ofdental implantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidance ofthe surgical instruments.	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra- operative) phasesof dental implantation surgery.The system provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidanceof the surgical instruments.	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
TechnologicalCharacteristics	NGSSubject Device	NGS with Chairside SplintPredicate Device (K182776)	Comments
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 against Type BFElectric Shock	Type BF	Type BF	No difference
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 SingleAxis TorqueOverload Limit	20 Nm	20 Nm	No difference
Upper limitspecification forGuidance ArmTranslation Speed	1.25 m/s	1.25 m/s	No difference
TechnologicalCharacteristics	NGSSubject Device	NGS with Chairside SplintPredicate Device (K182776)	Comments
StorageRequirements	Store powered at RoomTemperature (68°F to 76°F or 20°Cto 24.4°C) and standard ambienthumidity (5% to 95%) in a dust free,clean environment.	Store powered at RoomTemperature (68°F to 76°F or 20°Cto 24.4°C) and standardambient humidity (5% to 95%) ina dust 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 be attachedchairside with use of acrylic ordeveloped with acrylic on apatient model in a dental lab.	No difference
Dental materials(acrylics or resins)	Alike (K942670-GC Pattern Resin) Cool Temp Natural (K041098) 3M ESPE ProTemp Plus (K033022-Protemp 3 Garant) Visalys Core (UV light curable) (K143104) EZ Pickup (UV light curable) (K984341-SternVantage Varnish LC Model 221001) Ufi Gel hard C (K030916) Triad C&B Material (UV light curable) (K850911)	Alike (K942670-GC Pattern Resin) Cool Temp Natural (K041098) 3M ESPE ProTemp Plus (K033022-Protemp 3 Garant) Visalys Core (UV light curable) (K143104) EZ Pickup (UV light curable) (K984341-SternVantage Varnish LC Model 221001) Ufi Gel hard C (K030916) Triad C&B Material (UVlight curable) (K850911)	No difference
	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 pulling off.	No difference
	Fiducial ArrayAttachment toSplint	The Fiducial Array attaches to thesplint during the CT scan to providea reference in the image.	The Fiducial Array attaches tothesplint during the CT scan toprovide a reference in theimage.	No difference
	Kinematic MountAttachment toSplint	The Kinematic Mount attaches tothe splint to provide a mountingpoint for the Fiducial Array andPatient Tracker.	The Kinematic Mount attachesto the splint to provide amounting point for the FiducialArray and Patient 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 Tracker andGuidance 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
TechnologicalCharacteristics	NGSSubject Device	NGS with Chairside SplintPredicate Device (K182776)	Comments
Sterilization	Steam	Steam	No difference.
Components
Patient TrackingDevice	Patient Tracker	Patient Tracker	No difference
Patient TrackingAttachmentSystem	Chairside Splint	Chairside Splint	No difference
Dental Drill Motorand Hand Piece	Aseptico Drill Motor (Model●No. AEU-7000LNE-70V)(K030163)Anthogyr Mont Blanc●handpiece (Aseptico ModelNo. AHP-85MBFO-CX)(K070084)	W&H Implant Med Electric DrillMotor (Implant Med SI 95Series), and an AnthogyrImpulsion handpiece (Model No.14400BP)	Brand change,functionallyequivalent
Drill Motor Collar	● Geometry to fit Aseptico● Increased size● Compression collet toimprove rigidity	● Geometry to fit W&H● Smaller size● Tension clamp forrigidity	Increasedrobustness of thedesign toimprove rigidityand toaccommodatedifferent drillbrand

Table 1: Summary of Technological Characteristics Comparison

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Prior Performance Testing from K173402:

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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Prior Performance Testing from K161399:

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Biocompatibility Testing

The biocompatibility evaluation for NGS components was conducted in accordance with

. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff Document issued on: June 16, 2016
. ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process

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

Electrical Safety

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)

Software and System Verification and Validation

ANSI AAMI IEC 62304:2006 Medical device software Software life cycle ● processes
Guidance for Industry and FDA Staff Guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

Software testing summary is in table 3.

Verification / Validation Type	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
Verification / Validation Type	Description
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 Boundary ConditionTesting	Testing the mechanical boundaries of the Control Software andGuidance Arm.
Control Software GravityCalibration Verification	Verifying that the Gravity Calibration is effective over multiple start-upshut down cycles
Work Volume and Floor GridVerification	Verifying the design and functionality of the Work Volume and FloorGrid features in the application software.
Accuracy Verification: PatientTracker	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 Rate Verification	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 Calibration Verification	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 / Shutdown ProcessVerification	Qualitative evaluation of all start-up / shutdown steps performed in asimulated clinical environment.
Verification / Validation Type	Description
Start-Up Joint PositionIdentification	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 Adjustment toPatient 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 of UserRequirements	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 of UserRequirements for SplintApplication and Removal	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 of UserRequirements for Changes madeto Patient Tracker 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

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

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Performance Testing Submitted with this Submission

. ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices - Applications of risk management to medical devices
. ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products --. Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
Neocis-Total system accuracy verification
Neocis-End user validation
- Simulated procedure on typodont

Conclusion:

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The indications for use are unchanged. The technological changes do not raise different questions of safety and effectiveness. The new parts perform in a substantially equivalent manner to the predicates.

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.