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

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120).

In terms of previously FDA-cleared indications for use, the Neocis Guidance System (NGS) (K161399) 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 system allows the user to plan the surgery virtually in our Neocis Planning Software Application installed on the NGS planning station or on a 3rd party PC (K191363). The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDA-cleared powered bone cutting instrument (K191605).

The patient tracking portion of the NGS is comprised of linkages from the patient to 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 NGS 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 implant process occurs in two phases: (1) The dental surgeon plans the surgical procedure with the planning software, on the day of surgery or sometime prior if a pre-operative CT scan was taken at an earlier visit. A virtual dental implant, selected from the dental implant library or using a generic model, both contained within our planning software, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, provides haptic feedback to the surgeon by constraining the motion of 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 surgeon may modify the plan intraoperatively, if needed, has direct visualization of the patient anatomy, and is always in control of the surgical instrument.

Key safety features include:

Emergency stop
Safety pause
Audio and visual queues
Drill torque limits
Surgeon control

The subject device in this submission is the new Clamped Chairside Patient Splint (C-CPS). The C-CPS offers our users an alternative to acrylic-type dental material affixation. The subject device replaces the acrylic-type dental material locking mechanism of affixation with a clamplike mechanism of affixation using softer dental impression (registration) material, alignment slots, and an approximation screw. The clamping screw is not a bone screw, and it does not interact directly with the patient. The screw is positioned above the teeth inside the splint. The subject device is essentially a CPS (K173402) that has been bisected lengthwise with screw holes and alignment slots in each half to approximate the two halves around the patient's stable teeth. The dental impression material is placed inside the splint to form a tight conformational gripping surface between the splint and the teeth. The dental impression material conforms the shape of the patient's teeth to form a large gripping surface area. The C-CPS initial placement is like a dental impression tray. A torque-brake screwdriver with hex bit is used to tighten and loosen the screw. The proper C-CPS model (left/right or anterior/posterior) should be selected based upon the accommodation of the patient's anatomy and the intended surgical location.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS). The submission aims to demonstrate substantial equivalence to a predicate device, the NGS with Chairside Splint (K173402), by introducing a new clamping mechanism for the patient splint.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device and lists several identical technological characteristics, including system accuracy specifications.

Characteristic	Acceptance Criteria (from Predicate)	Reported Device Performance (NGS with C-CPS)
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 Requirements	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512 x 512, Full 13 cm 21 sec, Multi 2 DICOM format	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512 x 512, Full 13 cm 21 sec, Multi 2 DICOM format

Explanation of the Acceptance Criteria for the C-CPS:

The main purpose of this submission is the introduction of the Clamped Chairside Patient Splint (C-CPS) as an alternative to the existing Chairside Patient Splint (CPS) (K173402). Therefore, the "acceptance criteria" are not new performance metrics for the overall guidance system, but rather demonstrate that the new C-CPS component does not negatively impact the established performance of the NGS system and meets safety and functional requirements.

The document lists several verification activities to confirm the C-CPS's performance in relation to these system accuracy and functional requirements. These are implicitly the acceptance criteria for the C-CPS module itself:

Clamped Chairside Patient Splint (C-CPS) Splint Deflection Test with Optical Tracking: (Implicit acceptance: deflection within acceptable limits to maintain system accuracy).
Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Teeth): (Implicit acceptance: pressure within safe and effective limits).
Clamped Chairside Patient Splint (C-CPS) Kinematic Mount Repeatability: (Implicit acceptance: provides consistent and repeatable connection for tracking, contributing to overall system accuracy).
Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Soft Tissue): (Implicit acceptance: pressure within safe and effective limits).
Clamped Chairside Patient Splint (C-CPS) Removal Force Test: (Implicit acceptance: allows for safe and effective removal).
Clamped Chairside Patient Splint (C-CPS) DOE for Parameter Evaluation: (Implicit acceptance: relevant parameters are optimally defined).
Clamped Chairside Patient Splint (C-CPS) Screw Failure Test: (Implicit acceptance: screw designed to withstand expected forces without failure).
Clamped Chairside Patient Splint (C-CPS) Lingual-Buccal Assembly Failure Torque: (Implicit acceptance: assembly maintains integrity under expected torque).
Dimension Analysis (Clamped Chairside Patient Splint (C-CPS) vs. Chairside Patient Splint (CPS)): (Implicit acceptance: dimensional compatibility and understanding of differences).
Total System Accuracy: (Implicit acceptance: overall system accuracy, including the C-CPS, remains within the established RMS < 1 mm for lateral/depth and RMS < 6.0° for angular accuracy).

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

The document mentions "Verification" and "Validation" activities, but does not explicitly state the sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

The "C-CPS Technique Validation: Simulated Clinical Testing" is described as a "nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a C-CPS directly to a patient." This indicates the testing was likely conducted in a controlled lab environment rather than on actual patients.

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

The document states, "C-CPS Technique Validation: Simulated Clinical Testing... To validate the user requirements of the C-CPS, as performed by a surgeon (end-user)." This implies that at least one "surgeon (end-user)" was involved in the qualitative evaluation. However, the exact number of experts, their qualifications, and how "ground truth" was established are not specified. Given it's a simulated clinical test, the "ground truth" would likely be based on the qualitative assessment of the surgeon(s) performing the task.

4. Adjudication Method for the Test Set:

No adjudication method is described for the verification or validation tests. The qualitative evaluation by a "surgeon (end-user)" suggests a subjective assessment rather than a formal adjudication process using multiple reviewers.

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 was performed or described. The device is a robotically assisted surgical system, not an AI diagnostic tool that assists human readers/interpreters in a diagnostic task. The "AI" component is likely in the planning software and robotic guidance, not in image interpretation.

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

No standalone algorithm-only performance study is explicitly described. The device is a "computerized navigational system" that provides "navigational guidance of the surgical instruments," which implies a human-in-the-loop system. The surgeon is always "in control of the surgical instrument" and receives haptic feedback. The "Total System Accuracy" test would represent the performance of the system with all its components, including the robotic guidance based on the algorithm, but this is not a standalone algorithm without a physical output or human interaction.

7. The Type of Ground Truth Used:

For the performance characteristics like "System Lateral/Depth/Angular Accuracy," the ground truth would typically be established by highly precise measurement tools (e.g., optical tracking systems, CMMs) in a controlled laboratory setting, comparing the planned trajectory to the actual trajectory.

For the "C-CPS Technique Validation: Simulated Clinical Testing," the ground truth for "user requirements" and "rigidity" would be qualitative assessment by a surgeon (end-user), likely against predefined criteria for ease of application, stability, and removal.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This submission describes a modification to a physical component (patient splint) of an existing robotic guidance system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or prediction). The core "planning software" is mentioned as Neocis Planning Software Application v1.2 (K161399) or v1.8.1 (K191363), but no details on training data for these software versions are provided in this document.

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

Not applicable/Not provided. As explained above, this submission doesn't detail the training of an AI model.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a hardware modification (the C-CPS) to an existing dental navigation system. The "acceptance criteria" are predominantly implicit in proving that the new component does not degrade the established performance specifications of the overall system and meets new functional and safety requirements related to its design and use. The studies performed are primarily verification and validation tests in a simulated environment to confirm these aspects, rather than clinical trials or AI-specific performance evaluations involving large datasets or multiple human readers.

Summary

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

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

October 19, 2020

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

Re: K202100

Trade/Device Name: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: July 24, 2020 Received: July 29, 2020

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.

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

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

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 mediation-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 ''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

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

Indications for Use

510(k) Number (if known) K202100

Device Name

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):
X Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary - K202100

l. Submitter

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

Contact Person: Thomas Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: October 19, 2020

II. Device

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

lll. Predicate Devices

Neocis Guidance System (NGS) with Chairside Splint (K173402)

IV. Indications for Use

V. Device Description:

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120).

The system allows the user to plan the surgery virtually in our Neocis Planning Software

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

Application installed on the NGS planning station or on a 3rd party PC (K191363). The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDA-cleared powered bone cutting instrument (K191605).

Key safety features include:

. Emergency stop
Safety pause
Audio and visual queues
Drill torque limits
Surgeon control

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

interact directly with the patient. The screw is positioned above the teeth inside the splint. The subject device is essentially a CPS (K173402) that has been bisected lengthwise with screw holes and alignment slots in each half to approximate the two halves around the patient's stable teeth. The dental impression material is placed inside the splint to form a tight conformational gripping surface between the splint and the teeth. The dental impression material conforms the shape of the patient's teeth to form a large gripping surface area. The C-CPS initial placement is like a dental impression tray. A torque-brake screwdriver with hex bit is used to tighten and loosen the screw. The proper C-CPS model (left/right or anterior/posterior) should be selected based upon the accommodation of the patient's anatomy and the intended surgical location.

VI. Comparison of Technological Characteristics:

The indications for use (IFU) of the subject device have remained unchanged from the predicate device Acrylates allergy contraindication is not applicable to the C-CPS. There are no changes to the non-splint NGS hardware or software in this submission.

TechnologicalCharacteristics	NGS with C-CPSSubject Device	NGS with CPS K173402Predicate Device	SE Analysis
Patient ContactingMaterials	lxef®-HC-1022	Same as the subjectdevice	Identical
NGS Power Supply	120VAC/60 Hz	Same as the subjectdevice	Identical
Type of Protectionagainst Electric Shock	Class I Equipment	Same as the subjectdevice	Identical
Equipment Suitablefor use in thepresence ofFlammableMixtures?	No	Same as the subjectdevice	Identical
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012and A2:2010/(R)2012(Consolidated Text) Medicalelectrical equipment - Part1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD)	Same as the subjectdevice	Identical
TechnologicalCharacteristics	NGS with C-CPS	NGS with CPS K173402	SE Analysis
	Subject Device	Predicate Device
ElectromagneticDisturbances	IEC 60601-1-2 Edition 4.02014-02Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances -Requirements and tests	Same as the subjectdevice	Identical
IngressProtection	IPXO	Same as the subjectdevice	Identical
Mode ofOperation	Continuous Operation	Same as the subjectdevice	Identical
System LateralAccuracy	RMS < 1 mm	Same as the subjectdevice	Identical
System DepthAccuracy	RMS < 1 mm	Same as the subjectdevice	Identical
System AngularAccuracy	RMS < 6.0°	Same as the subjectdevice	Identical
CT Scan QualityRequirements	0.3 mm Voxel, 0.3 mmSlice Thickness, Matrix512 x 512, Full 13 cm 21sec, Multi 2 DICOMformat.	Same as the subjectdevice	Identical
F/T Sensor ForceMeasurement Range	+/- 30 N	Same as the subjectdevice	Identical
F/T Sensor TorqueMeasurement Range	+/- 2 Nm	Same as the subjectdevice	Identical
F/T Sensor SingleAxis Force OverloadLimit	200 N	Same as the subjectdevice	Identical
F/T Sensor SingleAxis TorqueOverload Limit	20 Nm	Same as the subjectdevice	Identical
Upper limitspecification forGuidance ArmTranslation Speed	1.25 m/s	Same as the subjectdevice	Identical

TechnologicalCharacteristics	NGS with C-CPSSubject Device	NGS with CPS K173402Predicate Device	SE Analysis
StorageRequirements	Store powered at RoomTemperature (68°F to 76°For 20°C to 24.4°C) andstandard ambienthumidity (5% to 95%) in adust free, cleanenvironment.	Same as the subjectdevice	Identical
Splint Purpose	Physical linkage to patientvia Patient Tracker andKinematic Mountconnected to:• C-CPS, or• CPS (K173402)	Same as the subjectdevice	Addition of C-CPS to NGSworkflow.
Splint Models	-Posterior (left &right)-Anterior (left &right);Each with onealuminum screw	-Posterior (left &right)-Anterior (left &right)	Addition of screw
Splint Volume	Approximately 16kmm3	Approximately 13kmm3	Subject deviceapproximately 20%larger than predicate
Splint Surface Area	Anterior Model:-Mucosa: 206 mm²-Teeth: 1062 mm²Posterior Model:-Mucosa: 155 mm²-Teeth 898 mm²	Anterior Model:-Mucosa: 200 mm²-Teeth: 725 mm²Posterior Model:-Mucosa: 65 mm²-Teeth 583 mm²	C-CPS is % Largerthan CPS:Anterior Model:-Mucosa: 3%-Teeth: 46%Posterior Model:-Mucosa: 140%-Teeth: 54%
Patient ContactingMaterials	-IXEF-#8-32 UNC 6061aluminum screw-316 Stainless steelhex bit	-IXEF	Addition of screw andscrewdriver bitmaterials
Splint ApplicationTools	-Torque-brakescrewdriver set to1.8Nm with 9/64-inchhex bit;-Dental materialapplicator	Dental materialapplicator	Added screwdriver
Dental MaterialsUsed with the Splints	Dental impressionmaterial DMG O-Bite(Luxabite K013236)	Lang Jet ToothShade(K083195)(Additionalmaterials cleared inK182776)	Use of softerimpression materialsinstead of hardacrylic-like materials,both FDA-cleared fordental use
TechnologicalCharacteristics	NGS with C-CPSSubject Device	NGS with CPS K173402Predicate Device	SE Analysis
Splint Affixation	Clamping and grippingteeth with compressiveforce and dentalimpression materialgrip (friction force)	Hardening andlocking of dentalmaterials to teeth(with mildcompression due tomaterial shrinkage)	Reliance on increasedcompression force forfixation
Splint removal	Backing out clampingscrew and manuallyseparating the two halves	CPS can be removedmanually or by poweredcutting tool	Splint cutting not needed
Dental MaterialRemoval	Standard dentaltechniques	Same as subject device	Identical
Fiducials	Fiducial Array (FA)attached to splint	Same as the SubjectDevice	NGS Fiducial is not patientcontacting
Kinematic mount	Integrated into the splint	KM as separate part	Similar implementation
Biocompatibility	Yes(ISO 10993-1, -5, -10, -12)Provided nonsterile	Same as the SubjectDevice	Identical
Sterilization	User sterilized by Steam(ISO 17665-1)	Same as the SubjectDevice	Identical
Use	Splint single use onlyTools reusable	Splint single use only	Addition of tools forsubject device
Dental Drill Motorand Hand Piece	Held by NGS guidance arm Aseptico Drill Motor (Model No. AEU-7000LNE-70V) (K030163) Anthogyr Mont Blanc handpiece (Aseptico Model No. AHP-85MBFO-CX) (K070084)	Same as the SubjectDevice	Aseptico cleared for usewith NGS under K191605,NGS guidance arm clearedunder K161399
Planning Software	Neocis Planning Software Application v1.2 (K161399), or Neocis Planning Software Application for 3rd Party PCs v1.8.1 (K191363)	Same as the SubjectDevice	Identical
Technological	NGS with C-CPS	NGS with CPS K173402	SE Analysis
Characteristics	Subject Device	Predicate Device
Software Level ofConcern	Moderate	Same as the SubjectDevice	Identical

Table 1. Comparison of Technologies Characteristics

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

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

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

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

Comparison of the Indications for Use and Contraindications

The indications for use (IFU) of the subject device are identical to the predicate device. Acrylates allergy contraindication was removed since it is no longer applicable.

Technological	NGS with C-CPS	CPS K173402	SE Analysis
Characteristics	Subject Device	Predicate Device
Indications forUse (IFU)	The Neocis GuidanceSystem (NGS) is acomputerizednavigational systemintended to provideassistance in both theplanning (pre-operative)and the surgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures and providesnavigational guidance ofthe surgical instruments	The Neocis Guidance System(NGS) is a computerizednavigational systemintended to provideassistance in both theplanning (pre-operative) andthe surgical (intra-operative)phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigationalguidance of the surgicalinstruments	Identical
Technological	NGS with C-CPS	CPS K173402	SE Analysis
Characteristics	Subject Device	Predicate Device
Contraindications	The Neocis GuidanceSystem is not intended foruse with patients thathave insufficient bone orteeth to retain a NeocisChairside Patient Splint(CPS) rigidly throughout asurgical procedure.The Neocis ChairsidePatient Splint (CPS) shouldnot be affixed to patientsthat exhibit:• Periodontaldisease to includeloose teeth andinflamed tissue• Fixed orthodonticappliances, bridges,or dental implants• Patients with ahistory of jaw orTMJ pain	The Neocis Guidance Systemis not intended for use withpatients that haveinsufficient bone or teeth toretain a Neocis ChairsidePatient Splint (CPS) rigidlythroughout a surgicalprocedure.The Neocis Chairside PatientSplint (CPS) should not beaffixed to patients thatexhibit:• Periodontal diseaseto include loose teethand inflamed tissue• Fixed orthodonticappliances, bridges,or dental implants• Patients with ahistory of jaw or TMJpain• Patients with allergiesto methylmethacrylates	Acrylates allergycontraindicationnot needed

Table 2. Comparison of the Indications for Use and Contraindications

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

VII. Performance Testing

Use of FDA-Recognized Consensus Standards

A risk analysis, sterilization, and biocompatibility testing were conducted on the final finished device per the following standards:

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

. ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices -Applications of risk management to medical devices
. 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
. ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
. ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ANSI AAMI ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

Verification

Clamped Chairside Patient Splint (C-CPS) Splint Deflection Test with Optical Tracking
Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Teeth)
Clamped Chairside Patient Splint (C-CPS) Kinematic Mount Repeatability ●
Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Soft Tissue)
Clamped Chairside Patient Splint (C-CPS) Removal Force Test
Clamped Chairside Patient Splint (C-CPS) DOE for Parameter Evaluation
Clamped Chairside Patient Splint (C-CPS) Screw Failure Test
Clamped Chairside Patient Splint (C-CPS) Lingual-Buccal Assembly Failure Torque
Dimension Analysis (Clamped Chairside Patient Splint (C-CPS) vs. Chairside Patient Splint (СРУ))
Total System Accuracy

Validation

. C-CPS Technique Validation: Simulated Clinical Testing
- O To validate the user requirements of the C-CPS, as performed by a surgeon (enduser). This validation activity is a nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a C-CPS directly to a patient.

Animal or clinical testing was not conducted for the subject device.

Conclusion:

The C-CPS is substantially equivalent to the predicate. There are no changes to the intended use or to the fundamental technology.

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.