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. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Device Description

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). 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 precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) 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 holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental 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. The NGS can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which include the Chairside Patient Splint (CPS) (K173402), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS 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, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (X-Guide Surgical Navigation System, K150222) rather than defining absolute acceptance criteria for novel performance claims. However, specific accuracy metrics are listed and compared.

Acceptance Criteria (from Predicate/Prior Clearance)	Reported Device Performance (NGS with Patient Splints)
System Lateral Accuracy: RMS < 1 mm	RMS < 1 mm
System Depth Accuracy: RMS < 1 mm	RMS < 1 mm
System Angular Accuracy: RMS < 6.0°	RMS < 6.0°
CT Scan Quality Requirement: Not specified for predicate, but NGS has tighter tolerances	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512 x 512, Full 13 cm 21 sec. Multi 2 DICOM format.
F/T Sensor Force Measurement Range: N/A for predicate	+/- 30 N
F/T Sensor Torque Measurement Range: N/A for predicate	+/- 2 Nm
F/T Sensor Single Axis Force Overload Limit: N/A for predicate	200 N
F/T Sensor Single Axis Torque Overload Limit: N/A for predicate	20 Nm
Upper limit specification for Guidance Arm Translation Speed: N/A for predicate	1.25 m/s
Biocompatibility: Yes (ISO 10993-1, -5, -10, -12)	Yes (ISO 10993-1, -5, -10, -12)
Sterilization: Steam (ISO 17665-1)	Steam (ISO 17665-1)
Software Level of Concern: Moderate	Moderate

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

EPS Cadaver Testing:
- Sample Size: 2 human cadaver heads.
- Data Provenance: Not specified, but likely from a US-based facility where cadaver studies are conducted. This is a prospective test.
IDE Study G190282 (Clinical Validation):
- Sample Size: 10 adult patients (5 per site), resulting in 67 dental implants placed.
- Data Provenance: Prospective, two-center study conducted in private practices (presumably in the US, as it's an FDA submission).

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

EPS Cadaver Testing: One surgeon experienced with the NGS performed the procedures and answered qualitative performance questions. Qualifications: "Surgeon experienced with the NGS."
IDE Study G190282 (Clinical Validation): Two clinical investigators (surgeons), one per site. Qualifications: "Fully licensed to practice dental implant surgery and were trained on use of the study device prior to starting the study."

4. Adjudication Method for the Test Set

Cadaver Testing: Qualitative; likely based on the single surgeon's assessment. No formal adjudication method like 2+1 or 3+1 is mentioned.
Clinical Validation (IDE Study): Implant location accuracy was examined using a "before and after analysis of CT data showing the location of the implant in the preop plan versus postop CT." It's not explicitly stated if independent experts or an adjudication panel reviewed these "before and after" CTs. The statement "All implants met system specifications for accuracy" suggests an evaluation against a predetermined quantitative threshold rather than a consensus-based adjudication process.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The study focuses on the performance and usability of the device for dental implant surgery, with the device providing robotic guidance, rather than an AI assistance tool for human readers interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the specific accuracy metrics (Lateral, Depth, Angular Accuracy), it's stated "The full system is used to perform a simulated clinical procedure on a typodont to measure the system accuracy," and also "The Patient Tracker was evaluated for accuracy per ASTM F2554," and "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." While these involve the system, the core device described is a robotic guidance system, not an AI algorithm that operates standalone. The accuracy values likely represent the standalone performance of the robotic system in guiding surgical instruments.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

System Accuracy (Lateral, Depth, Angular): Ground truth was established by precise measurements against a "calibrated CMM" (Coordinate Measuring Machine) for the guidance arm's positional accuracy and a "typodont" (dental model) for overall system accuracy. For clinical validation, post-operative CT data was compared to the pre-operative plan.
Clinical Validation (IDE Study): The ground truth for effectiveness was direct comparison of post-operative implant location (via CT) against the pre-operative plan. Safety was assessed via follow-up for wound site healing. Usability was assessed via qualitative feedback from surgeons.

8. The Sample Size for the Training Set

The document does not specify a training set sample size for any machine learning or AI component. The Neocis Guidance System is described as a "computerized navigational system" providing "robotic guidance," and while it uses software and control systems, the text doesn't indicate a machine learning model that would typically have a "training set" in the context of image interpretation or diagnostic aid. The "planning software" is described as a tool for virtual implant placement.

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

As no training set for a machine learning component is described, this question is not applicable based on the provided text.

Summary

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July 28, 2020

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

Re: K200805

Trade/Device Name: Neocis Guidance System (NGS) with Patient Splints Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: April 28, 2020 Received: April 29, 2020

Dear Thomas E. 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 probibitions 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

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801); medical device reporting (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-devices/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 (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 "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200805

Device Name

Neocis Guidance System (NGS) with Patient Splints

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 logo consists of the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a horizontal gray line that extends over the "neo" part of the word. A vertical gray line intersects the horizontal line above the "c" in "neocis", forming a plus sign with a small circle at the intersection.

510(k) Summary

I. Submitter

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

Contact Person: Thomas E. Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: July 27, 2020

II. Device

Trade Name:	Neocis Guidance System (NGS) with Patient Splints
Common Name:	Dental Stereotaxic Instrument
Classification Name:	Bone cutting instrument and accessories (21 CFR 872.4120)
Classification:	Class II
Product Code:	PLV

III. Predicate Devices

X-Guide Surgical Navigation System (K150222) ●

IV. Reference Devices

Neocis Chairside Splint (K173402)
. Dentsply Sirona Cerec Guides (K190059)
. Stryker Mandibular Fracture and Reconstruction Fixation System, Bone Fixation Screws (K014263)

V. Indications for Use

VI. Device Description

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Image /page/4/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 a light orange color. Above the word is a thin gray horizontal line that extends beyond the letters on both sides. A thin gray vertical line intersects the horizontal line at a small gray circle above the "i" in "neocis".

VII. Comparison of Technological Characteristics

This submission includes changes to the indications for use and a new patient splint for use in partially edentulous and fully edentulous patients. There are no changes to the NGS hardware or software in this submission. Since the NGS (K161399) was previously found to be substantially equivalent to K150222, we refer to our prior clearance for a full technological comparison. We have selected K150222 again as a predicate device because we now have technology that allows us to match its performance requirements for fully edentulous patients, which is the focus of this submission. The differences introduced by this modification are detailed in Table 1: Comparison of technological characteristics to the predicates below.

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Image /page/5/Picture/6 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. 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 top.

TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
Indications forUse (IFU)	The NeocisGuidanceSystem (NGS)is acomputerizednavigationalsystemintended toprovideassistance inboth theplanning (pre-operative) andthe surgical(intra-operative)phases ofdentalimplantationsurgery. Thesystemprovidessoftware topreoperativelyplan dentalimplantationprocedures andprovidesnavigationalguidance of thesurgicalinstruments.The NGS isintended foruse in partiallyedentulous andfully edentulousadult patientswho qualify fordentalimplants.	The X-Guide(R)Surgical NavigationSystem is acomputerizednavigational systemintended to provideassistance in both thepreoperative planningphase and intra-operative surgicalphase of dentalimplantationprocedures. Thesystem providessoftware topreoperatively plandental implantationprocedures andprovides navigationalguidance of thesurgical instruments.The device is intendedfor use for partiallyedentulous andedentulous adult andgeriatric patients whorequire dentalimplants as part oftheir treatment plan.	The NeocisGuidanceSystem(NGS) is acomputerizednavigationalsystemintended toprovideassistance inboth theplanning(pre-operative)and thesurgical(intra-operative)phases ofdentalimplantationsurgery. Thesystemprovidessoftware topreoperatively plandentalimplantationproceduresandprovidesnavigationalguidance ofthe surgicalinstruments.	N/A	N/A	Added conditionand patientpopulation frompredicate.
TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
Contraindications	The NeocisGuidanceSystem is notintended foruse withpatients thathaveinsufficientbone to retaina NeocisEdentulousPatient Splint(EPS) rigidlythroughout asurgicalprocedure.The EPSshould not beaffixed topatients thatexhibit:•Patientswithinsufficientbone quality•Patientswith ahistory ofjaw or TMJpain	Medical conditionswhich contraindicatethe use of X-Guideand its associatedapplications includeany medicalconditions which maycontraindicate themedical procedureitself.Only for those wheredental implants areappropriate & patientis healthy.• Not for use withpatients less than21 years of age.• Not for use withphotosensitiveepileptic patients.Patient sensitivitymay be causedfrom the LEDs.	TheNeocisGuidanceSystem isnotintendedfor usewithpatientsthat haveinsufficient bone toretain aNeocisEdentulous PatientSplint(EPS)rigidlythroughouta surgicalprocedure.The EPSshould notbe affixedto patientsthatexhibit:Patientswithinsufficient bonequalityPatientswith ahistory ofjaw or TMJpainPatientswithallergies toacrylates	N/A	N/A	Adjusted forEPS.Acrylic-likedental materialsare not used withthe EPS.Similar to X-Guide.
PatientContactingMaterials	• Ixef®-HC-1022• StainlessSteel• TitaniumAlloy	• StainlessSteel• TitaniumAlloy	IXEF	StainlessSteel	Titanium	Addition ofpredicatematerials
NGS PowerSupply	120VAC/60 Hz	120VAC/60Hz	Same as thesubjectdevice	N/A	N/A	Same
Type ofProtectionagainst ElectricShock	Class IEquipment	Class I Equipment	Same as thesubjectdevice	N/A	N/A	Same
TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
EquipmentSuitable foruse in thepresence ofFlammableMixtures?	No	No	N Same asthe subjectdevice /A	N/A	N/A	Same
ElectricalSafety	ANSI AAMIES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(ConsolidatedText) Medicalelectricalequipment -Part 1: Generalrequirementsfor basic safetyand essentialperformance(IEC 60601-1:2005, MOD)	ANSI AAMIES60601-1:2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text)Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performance(IEC 60601-1:2005,MOD)	Same as thesubjectdevice	N/A	N/A	Same
Electromagnetic Disturbances	IEC 60601-1-2Edition 4.02014-02Medicalelectricalequipment -Part 1-2:Generalrequirementsfor basic safetyand essentialperformance -CollateralStandard:Electromagnetic disturbances .Requirementsand tests	IEC 60601-1-2Edition 4.0 2014-02Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests	Same as thesubjectdevice	N/A	N/A	Same
IngresSProtection	IPX0	IPX2	Same as thesubjectdevice	N/A	N/A	The X-Guide hasa higher IPXrating. NGS is 0because of ourdraping.
ModeofOperation	ContinuousOperation	Continuous Operation	Same as thesubjectdevice	N/A	N/A	Same
SystemLateralAccuracy	RMS < 1 mm	RMS < 1 mm	Same as thesubjectdevice	N/A	N/A	Same
TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
SystemDepthAccuracy	RMS < 1 mm	RMS < 1 mm	Same as thesubjectdevice	N/A	N/A	Same
SystemAngularAccuracy	RMS < 6.0°	---	Same as thesubjectdevice	N/A	N/A	Same
CT ScanQualityRequirementS	0.3 mmVoxel, 0.3mm SliceThickness,Matrix 512x 512, Full13 cm 21sec. Multi 2DICOMformat.	---	Same as thesubjectdevice	N/A	N/A	NGS has tightertolerances thanX-Guide.
F/T SensorForceMeasurementRange	+/- 30 N	N/A	Same as thesubjectdevice	N/A	N/A	The X-Guidedoes not use F/Tsensors
F/T SensorTorqueMeasurementRa nge	+/- 2 Nm	N/A	Same as thesubjectdevice	N/A	N/A	The X-Guidedoes not use F/Tsensors
F/T SensorSingle AxisForce OverloadLimit	200 N	N/A	Same as thesubjectdevice	N/A	N/A	The X-Guidedoes not use F/Tsensors
F/T SensorSingle AxisTorqueOverload Limit	20 Nm	N/A	Same as thesubjectdevice	N/A	N/A	The X-Guidedoes not use F/Tsensors
Upper limitspecificationfor GuidanceArmTranslationSpeed	1.25 m/s	N/A	Same as thesubjectdevice	N/A	N/A	The X-Guidedoes not have aguidance arm.
StorageRequirements	Store poweredat RoomTemperature(68°F to 76°For 20°C to24.4°C) andstandardambienthumidity (5%to 95%) in adust free,cleanenvironment.	-20 to 60 °C, 10-95%humidity	Same as thesubjectdevice	N/A	N/A	Same
TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
Patient Tracking	Physicallinkage topatient viaPatientTracker andKinematicMountconnected to:· EPS. or• CPS(K173402)	Stereo-LED Opticaltracking of:• E-clip• Tracker Arm· X-Corner PatientTracker	Same as thesubjectdevice withCPS	N/A	N/A	Addition of EPSto NGSworkflow, whichis SE to the X-Guide E-clip.
Affixation oftrackingtechnology topatient	· EPSwithsleevesandbonescrews· CPSwithdentalmaterials(K182776)	Metal strip(stainless steelor titanium bonefixation plate)and titaniumbone screws	DentalMaterials	Sleeves	Screwsandscrewdriver	Samemethods forsubjectdevice andpredicatedeviceusingreferencedevices forimplementation
Patientattachmentremoval	· CPS canberemovedmanuallyor bypoweredcuttingtool• EPS isremovedbyunscrewing thebonescrews	The metal strip isremoved byunscrewing the bonescrews	Standarddentaltechniques	N/A	Use ofscrewdriver	Addition ofpredicateremovaltechniques andreference deviceimplementation
Fiducials	FiducialArray (FA)attached tosplint	X-clip fiducialattached to patient'steeth or organicfiducials in patient'sbone	Same as theSubjectDevice	N/A	N/A	NGS Fiducial isnot patientcontacting
Kinematicmount	Integratedinto the splint	E-Clip tracker armslot integrated intometal strip (boneplate)	KM asseparatepart	N/A	N/A	Similarimplementation
Biocompatibility	Yes (ISO10993-1, -5, -10, -12)	Yes (ISO 10993-1, -5,-10, -11,-12)	Yes (ISO10993-1, -5,-10, -12)	Yes (ISO10993-1, -5, -10, -12)	Yes (ISO10993-1, -5, -10, -12)	Same
TechnologicalCharacteristics	NGS withPatientSplintsSubjectDevice	X-Guide SurgicalNavigation SystemPredicate Device(K150222)	ReferenceDevice-CPSK173402	ReferenceDevice-SleevesK190059	ReferenceDevice-ScrewsK014263	SE Analysis
Sterilization	Steam (ISO17665-1)	Steam (ISO 17665-1)	Steam (ISO17665-1)	Steam(ISO17665-1)	Steam (ISO17665-1)	Same
Dental DrillMotor and HandPiece	• Held byNGSguidancearm• AsepticoDrill Motor(Model No.AEU-7000LNE-70V)(K030163)• AnthogyrMont Blanchandpiece(AsepticoModel No.AHP-85MBFO-CX)(K070084)	Not specified,handheld	Same as theSubjectDevice	N/A	N/A	Aseptico clearedfor use with NGSunder K191605,NGS guidancearm SE underK161399
PlanningSoftware	• NeocisPlanningSoftwareApplicationv1.2(K161399),or• NeocisPlanningSoftwareApplicationfor 3rd PartyPCs v1.8.1(K191363)	Implant PlanningSoftware XOS	Same as theSubjectDevice	N/A	N/A	SE underK161399
Software Levelof Concern	Moderate	Moderate	Same as theSubjectDevice	N/A	N/A	Same

Table 1: Comparison of technological characteristics to the predicates

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Image /page/6/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 a gold color. Above the word is a gray line that extends horizontally, with a small circle in the middle. A vertical gray line extends from the circle, creating a crosshair-like design above the word.

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Image /page/7/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a gray horizontal line that extends to the left and right of the word. A gray vertical line intersects the horizontal line at a small circle above the "o" in "neocis."

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Image /page/8/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. Above the word is a gray horizontal line, with a small circle in the middle. A vertical line extends from the circle.

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Image /page/9/Picture/1 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in a golden color. Above the word is a horizontal gray line, and a gray circle with a vertical line extending from it is positioned above the "i" in "neocis."

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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 letters in a golden color. Above the word is a horizontal gray line, and to the right of the word is a gray line with a circle in the middle. The logo is simple and modern, and the colors are eye-catching.

VIII. Performance Testing

The subject of this 510(k) was a modification to the indications for use and the addition of a splint for use in edentulous patients. There are no changes to the NGS in this submission. As such, NGS performance testing was not repeated.

Prior Performance Testing from K173402:

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

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	-0-(
D	417	C

Table 2: Summary of component and system verification and validation

Verification / Validation Type 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 a typodont assimulation 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 force on astandard splint mounted on a typodont per the IFU. In addition,evaluation of kinematic mount repeatability and patient anatomy accommodationanalysis.

Prior Performance Testing from K161399:

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.

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

Verification / Validation Type	Description
Simulated Use	Run through of Typical Use Case
Verification / Validation Type	Description
Boundary Condition	Testing of all potential boundary parameters in the Application Software
Registration	Testing of registration process
Case File Contents	Simulated use testing of features associated with saving / loading Cases
Error Case Injection	Simulating all error messages and pop-ups.
CT Scan Verification	Verification of the resolution and validity of CT Scans
Control SW Boundary ConditionTesting	Testing the mechanical boundaries of the Control Software and GuidanceArm.
Control Software Gravity CalibrationVerification	Verifying that the Gravity Calibration is effective over multiple start-up / shutdown cycles
Work Volume and Floor GridVerification	Verifying the design and functionality of the Work Volume and Floor Gridfeatures 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 by collecting 27data points in spaces within two work volumes (54 total points) against acalibrated CMM.
Communication Rate Verification	Force-Torque (F/T) Sensor to Control Software, Patient Tracker to ControlSoftware, Guidance Arm to Control Software and communication betweenApplication Software and Control Software rates were evaluated forappropriate speed.
End User Calibration Verification	Dimensional analysis and verification of Calibration Materials (CalibrationDrill Bit and Calibration End Effector Divot)
Verification / Validation Type	Description
F/T Sensor Verification	Guidance Arm speed limit testing and drift / idle F/T Sensor verification,intended to evaluate safety mitigations for Guidance Arm motion.
Start-Up / Shutdown ProcessVerification	Qualitative evaluation of all start-up / shutdown steps performed in asimulated clinical environment.
Start-Up Joint Position Identification	Verification to ensure system integrity of Guidance Arm in case any jointmotion that may have occurred while system was not powered.
User Emergency Safety Verification	Evaluation of time required for a Guidance Arm emergency shutdown, andemergency disconnection of the patient.
Guidance Arm Adjustment to PatientMotion	Simulation of Patient Tracker motion while system is in Drill Mode, and drillbit is in simulated bone block
Work Volume Verification	Assessment of physical design and cable management throughout availablework 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, performedby End User in simulated environment.
End User Validation of UserRequirements for Splint Applicationand Removal	An addendum to the NGS End User Validation to repeat validation stepsassociated with changes made to the design and instructions for the use of theNGS Splint.
End User Validation of UserRequirements for Changes made toPatient Tracker End Effector	An addendum to the NGS End User Validation to repeat validation stepsassociated with changes made to the design, and procedural steps associatedwith the Patient Tracker End Effector

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VERIFICATION

EPS Bench Testing

Sterilization Validation

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

Rigidly mounted EPS deflection measurement:

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Internal protocol to measure the deflection error introduced by the weight of our patient tracker.

Kinematic Mount Repeatability measurement:

Internal protocol to measure the repeatability of connection to the kinematic features of the device.

Total System Accuracy

The full system is used to perform a simulated clinical procedure on a typodont to measure the system accuracy.

PRE-CLINICAL VALIDATION

EPS Cadaver Testing

Human cadaver heads (n=2) were used to test EPS affixation and removal. One surgeon experienced with the NGS performed the procedures. Two splints (1 upper, 1 lower) were tested per surgeon. The Surgeon used bone screws to secure the splints. They attached the Patient Tracker to the EPS and moved the head around. Rigidity of splint affixation was checked qualitatively. Surgeons were asked qualitative performance questions about the device.

CLINICAL VALIDATION

IDE Study G190282

We conducted a prospective two-center (private practice) IDE study that was not randomized or controlled. The study was conducted in accordance with Good Clinical Practice (GCP) requirements. Informed consent was obtained from each patient and IRB approval was obtained prior to starting the study. It was feasibility style design to test the performance and usability of the device. We had two clinical investigators, one per site. Each site had 5 adult patients (10 total). Patients were male and representative of the dental implant surgery population. Patients were fully chronically edentulous or partially edentulated prior to surgery. Study sample size was based on the total number of dental implants placed using the study device (n=67). Endpoints included usability, safety, and effectiveness. Participating surgeons were fully licensed to practice dental implant surgery and were trained on use of the study device prior to starting the study. Patients were followed for two-weeks postop to examine wound site healing. There were no adverse events observed or reported. There were no usability concerns identified. We examined implant location accuracy using a before and after analysis of CT data showing the location of the implant in the preop plan versus postop CT. All implants met system specifications for accuracy. Patient risks have been mitigated by design. No new clinical risks were identified in comparison to the predicate and our preop risk assessment.

IX. Conclusion

There are no technological changes to the NGS in this submission. The changes in this submission are limited to the indications for use and the new edentulous patient splint. Changes to the indications for use specify the same condition and patient population as the X-Guide predicate. The EPS represents an operative guidance technique substantially equivalent to predicate. Our performance testing demonstrates substantially equivalent performance of the EPS as compared to the predicate. The bench and clinical testing are sufficient to demonstrate that the EPS is substantially equivalent to the predicate.

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.