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). The 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. The system allows the user to plan the surgery virtually in Yomi Plan. 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 third party powered bone cutting instrument. The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). 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. The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design. The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Technological Characteristics)	Reported Device Performance (NGS with IOFA Subject Device)
System Lateral Accuracy	RMS < 1 mm
System Depth Accuracy	RMS < 1 mm
System Angular Accuracy	RMS < 6.0°
CT Scan Quality Requirements	0.3 mm Voxel, 0.3 mm Slice Thickness, Matrix 512 x 512, Full 13 cm 21 sec, Multi 2 DICOM format.
F/T Sensor Force Measurement Range	+/- 30 N
F/T Sensor Torque Measurement Range	+/- 2 Nm
F/T Sensor Single Axis Force Overload Limit	200 N
F/T Sensor Single Axis Torque Overload Limit	20 Nm
Upper limit specification for Guidance Arm Translation Speed	1.25 m/s
Storage Requirements	Store powered at Room Temperature (68°F to 76°F or 20°C to 24.4°C) and standard ambient humidity (5% to 95%) in a dust free, clean environment.
Biocompatibility	Yes (ISO 10993-1, -5, 10, -12)
Sterilization	Steam (ISO 17665-1)
Software Level of Concern	Moderate

Notes on Acceptance Criteria: The document primarily uses "Same as the subject device" or similar phrasing for the predicate/reference devices, indicating that these performance metrics are consistent across the devices and establish the acceptance criteria for the new IOFA.

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 does not explicitly state the sample size for the test set for all verification activities. However, it mentions an "IOFA End User Validation" which is described as a "nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a Intraoral Fiducial Array directly to a patient." The specifics of this "validation" and its sample size are not detailed.

The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

For the "IOFA End User Validation," it states the validation was "as performed by a surgeon (end user)." The specific number of surgeons or their qualifications are not specified. For other performance tests like accuracy, the ground truth is likely established through a combination of manufacturing specifications, calibrated measurement tools, and engineering standards, rather than expert consensus on a test set.

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

The document does not describe any adjudication method for establishing ground truth from multiple experts. Given that most performance metrics are objective measurements (e.g., RMS accuracy), formal adjudication methods typically used for subjective clinical assessments are unlikely to be applied.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. The device is a "computerized navigational system" providing guidance, not an AI for image interpretation or diagnosis that would typically involve a multi-reader study. The text explicitly states, "Animal or clinical testing was not conducted for the subject device."

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

The device (NGS with IOFA) is described as a "computerized navigational system intended to provide assistance" and "provides navigational guidance of the surgical instruments." It also emphasizes that the "surgeon may modify the plan intraoperatively...and is always in control of the surgical instrument." This indicates a human-in-the-loop system. Therefore, a standalone (algorithm only) performance assessment as would be done for an AI diagnostic algorithm is not applicable in the same way. The performance metrics focus on the accuracy of the system's guidance (lateral, depth, angular accuracy), which are inherently tied to the interaction with the human user and surgical instruments.

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

The ground truth for the verification tests (Registration Testing, Kinematic Mount Repeatability, Scan Artifact Testing, Fit Clearance Simulation, Total System Accuracy, IOFA Deflection Test) appears to be based on:

Engineering measurements and calibrated standards: For system accuracy (lateral, depth, angular), sensor ranges, and physical properties.
Established industry standards: For electrical safety, electromagnetic disturbances, ingress protection, biocompatibility (ISO standards), and sterilization (ISO standards).
Design specifications: For CT scan quality requirements, guidance arm speed, and storage requirements.

For the "IOFA End User Validation," the ground truth is implied to be a qualitative assessment of rigidity and usability by a surgeon, simulating real-world application.

8. The sample size for the training set:

The document does not mention a training set size. The device is a "computerized navigational system" and its software (Yomi Plan v2.0) was cleared previously. This type of device relies on engineering design, calibration, and deterministic algorithms for guidance, rather than a machine learning model that requires a "training set" in the conventional AI sense.

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

As no training set is described for an AI/machine learning model, the process for establishing ground truth for a training set is not applicable or mentioned. The system's functionality is verified against established engineering and safety standards.

Summary

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Image /page/0/Picture/0 description: The image contains 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 square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Neocis Inc. William Tapia Vice President Regulatory Affairs/Quality Assurance 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K211129

Trade/Device Name: Neocis Guidance System (NGS) with Intraoral Fiducial Array Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: July 1, 2021 Received: July 2, 2021

Dear William Tapia:

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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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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Indications for Use

510(k) Number (if known) K211129

Device Name

Neocis Guidance System (NGS) with Intraoral Fiducial Array

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)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K211129

l. Submitter

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

Contact Person: William Tapia, Vice President Regulatory Affairs/Quality Assurance Date Prepared: July 27, 2021

II. Device

Trade Name: Neocis Guidance System (NGS) with Intraoral Fiducial Array 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

. Primary Predicate -
- Neocis Guidance System (NGS) (K161399) .
Reference Devices: ●
- . Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (K202348)
- . Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (K202100)

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) (Figure 1).

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In terms of previously FDA-cleared indications for use (K200805), 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.

Image /page/4/Picture/4 description: The image shows a Yomi robotic surgery system. The system includes a monitor, planning station PC, lift column, base cart, robotic guide arm, and patient tracker. The monitor and planning station PC display the Yomi logo. The robotic guide arm is positioned above the lift column and base cart.

Figure 1. Overview of the Neocis Guidance System (NGS). Major components list below.

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1. Monitor: Provides visibility of Yomi Plan for the user and operative teamduring a procedure. Displays the same information as the Planning station laptop PC
1. Planning Station Laptop PC: Used to execute Yomi Plan for planning and surgery. This PC is used during the procedure as well to execute commands for the Guide Arm. There is not separate keyboard. (Not intended for removal and use by itself for planning. Remote preplanning shall be executed on a different third party PC that is not connected to the NGS or provided by Neocis.)
1. Lift Column: Supports the Robotic Guide Arm and Patient Tracker assembly and is used to adjust the height of the assembly.
1. Base Cart: Supports the NGS, provides mobility with four swivel casters and locks in position with the foot brake lever. Contains control PC and UPS.
1. Robotic Guide Arm: Used to assist the surgeon in performing the surgery. Holds dental drill and provides haptic feedback on position with respect to the plan.
1. Patient Tracker: Attached to Patient Splint via the End Effector to monitor and relay any changes in patient position.

The system allows the user to plan the surgery virtually in Yomi Plan (K191363-cleared for use alone on third party PCs for preplanning). 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 third party 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) or Edentulous Patient Splint (EPS) (K200805), 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. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).

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.

For partially edentulous patients, surgeons now have the option to use our new Clamped

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Chairside Patient Splint (CCPS) (K202100). 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 (Yomi Plan), is placed at the desired location in the virtual patient model within our planning software. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve or maxillary sinuses. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS robotic arm, which holds the powered bone cutting tool, 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 bone cutting tool's foot pedal control is not connect to the NGS guide arm. Once the guide arm places the bone cutting tool into position according to the operative plan, the surgeon must activate the tool using the provided foot pedal associated with the bone cutting tool control box. 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
Automatic software-controlled safety pause triggered by joint or force limits
Audio and visual queues
Drill torque limits provided by the drill control console
Full surgeon control and direct visualization of the surgical field

The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design.

Image /page/6/Picture/11 description: The image shows two views of a black plastic tool. The tool has a flat, wide blade at the bottom and a handle with a hole at the top. There are several small, raised bumps on the handle. Text is visible on the blade of the tool.

Figure 2. LLUR and LRUL Intraoral Fiducial Arrays.

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The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.

The Intraoral Fiducial Array corresponds directly to the type of C-CPS being used. There are four basic types of C-CPS.

. Lower Left/ Upper Right (LLUR) Posterior- sits on teeth 11-15 for the maxilla or teeth 27-31 for the mandible.
. Lower Right/ Upper Left (LRUL) Posterior- sits on teeth 2-6 for the maxilla or teeth 18-22 for the mandible.
. Lower Left/ Upper Right (LLUR) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.
. Lower Right/Upper Left (LRUL) Anterior- sits on teeth 6-11 for the maxilla or teeth 22-27 for the mandible.

A LLUR C-CPS requires an LLUR Intraoral Fiducial Array, and an LRUL C-CPS requires an LRUL Intraoral Fiducial Array. See Figure 2 for LLUR and LRUL Fiducial Arrays.

The IOFA uses kinematic features to attach to the C-CPS and therefore has only one correct orientation.

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VI. Substantial Equivalence (SE) Discussion

The indications for use (IFU) and contraindications of the subject device have remained the same as the predicate and reference devices. Acrylates allergy contraindication was removed since it is no longer applicable. Contraindications remain the same as the previously cleared reference device K202100. The subject device represents a design change to the predicate device. They are functionally equivalent.

a. Comparison of the Indications for Use and Contraindications

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TechnologicalCharacteristics	K211129IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SubstantialEquivalenceAnalysis
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 GuidanceSystem (NGS) is acomputerizednavigational systemintended to provideassistance in boththe planning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures andprovidesnavigationalguidance of thesurgical instruments.	The NeocisGuidance System(NGS) is acomputerizednavigational systemintended to provideassistance in boththe planning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides accuratenavigationalguidance of surgicalinstruments, withregard to pre-operative planning	The Neocis GuidanceSystem (NGS) is acomputerizednavigational systemintended to provideassistance in boththe planning (pre-operative) and thesurgical (intra-operative) phases ofdental implantationsurgery. The systemprovides software topreoperatively plandental implantationprocedures andprovidesnavigational	No difference.
TechnologicalCharacteristics	K21xxxxIOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SubstantialEquivalenceAnalysis
Contraindications	The Neocis GuidanceSystem is not intendedfor use with patientsthat have insufficientbone or teeth to retain aNeocis ClampedChairside Patient Splint(C-CPS) rigidlythroughout a surgicalprocedure.The Neocis ChairsidePatient Splint (C-CPS)	The Neocis GuidanceSystem is not intendedfor use with patientsthat have insufficientbone or teeth toretain a Splint rigidlythroughout a surgicalprocedure.Patients with allergiesto methylmethacrylates.	The NeocisGuidance System isnot intended for usewith patients thathave insufficientbone or teeth toretain a FAS rigidlythroughout asurgical procedure.	The Neocis GuidanceSystem is notintended for usewith patients thathave insufficientbone or teeth toretain a NeocisClamped ChairsidePatient Splint (C-CPS) rigidlythroughout asurgical procedure.	Acrylates allergycontraindicationnot needed.Contraindicationsremain the same asthe previouslycleared referencedevice K202100.
TechnologicalCharacteristics	K21xxxxIOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SubstantialEquivalenceAnalysis
	should not be affixed topatients that exhibit:• Periodontal diseaseto include looseteeth and inflamedtissue• Fixed orthodonticappliances, bridges,or dental implants• Patients with ahistory of jaw or TMJpain		The FAS should notbe affixed topatients that exhibit:• Periodontaldisease to includeloose teeth andinflamed tissue	The Neocis ClampedChairside PatientSplint (C-CPS) shouldnot be affixed topatients that exhibit:• Periodontaldisease toinclude looseteeth andinflamed tissue• Fixedorthodonticappliances,bridges, ordental implants• Patients with ahistory of jaw orTMJ pain

Table 1. Comparison of the Indications for Use and Contraindications

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b. Comparison of Technology to Predicate Devices

There are no changes to the non-splint NGS hardware or software in this submission.

c. Head-to-Head Comparison

VII.	Table 2. Head-to-Head Comparison

TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
Patient ContactingMaterials	Ixef®-HC-1022Avaspire AV-651CF30	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
NGS Power Supply	120VAC/60 Hz	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
Type ofProtectionagainst ElectricShock	Class I Equipment	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
EquipmentSuitable for usein the presenceof FlammableMixtures?	No	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same

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TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
Electrical Safety	ANSI AAMIES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012andA2:2010/(R)2012(ConsolidatedText) Medicalelectricalequipment - Part1: Generalrequirements forbasic safety andessentialperformance (IEC60601-1:2005,MOD)	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
ElectromagneticDisturbances	IEC 60601-1-2Edition 4.0 2014-02Medical electricalequipment - Part1-2: Generalrequirements forbasic safety andessentialperformance -CollateralStandard:Electromagneticdisturbances -Requirementsand tests	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
IngressProtection	IPXO	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
Mode ofOperation	ContinuousOperation	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
System LateralAccuracy	RMS < 1 mm	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
System DepthAccuracy	RMS < 1 mm	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
System AngularAccuracy	RMS < 6.0°	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
CT Scan QualityRequirements	0.3 mm Voxel,0.3 mm SliceThickness,Matrix 512 x512, Full 13cm 21 sec,Multi 2 DICOMformat.	Same as thesubject device	Same as thesubject device.	Same as the subjectdevice.	Same
F/T Sensor ForceMeasurementRange	+/- 30 N	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
F/T SensorTorqueMeasurementRa nge	+/- 2 Nm	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
F/T Sensor SingleAxis ForceOverload Limit	200 N	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
F/T Sensor SingleAxis TorqueOverload Limit	20 Nm	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
Upper limitspecification forGuidance ArmTranslation Speed	1.25 m/s	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
StorageRequirements	Store poweredat RoomTemperature(68°F to 76°F or20°C to 24.4°C)and standardambienthumidity (5% to95%) in a dustfree, cleanenvironment.	Same as thesubject device	Same as thesubject device	Same as the subjectdevice	Same
Patient Tracking	Patient TrackingArm	Same as thesubject device withCPS	Same as thesubject device	Same as the subjectdevice	Same
Affixation oftrackingtechnology topatient	ClampedPatient Splint	Same as thesubject devicewith CPS	Same as thesubject devicewith FAS	Same as thesubject device	Same
Patientattachmentremoval	Standarddentaltechniques	Same as thesubject device.	Same as thesubject device.	Same as the subjectdevice.	Same
TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
Fiducials	The FiducialArray attachesto the splintduring the CTscan to providea reference inthe image.	The Fiducial Arrayattaches to thesplint during the CTscan to provide areference in theimage.	Not required	The Fiducial Arrayattaches to the splintduring the CT scan toprovide a referencein the image.	Same
Kinematicmount	KM integratedinto splint.	The KinematicMount attaches tothe splint toprovide a mountingpoint for theFiducial Array andPatient Tracker.	KM integrated intothe FAS	KM integrated intosplint.	Same
Biocompatibility	Yes(ISO 10993-1, -5,10, -12)	Yes(ISO 10993-1, -5, -10, -12)	Same as thesubject device	Same as the subjectdevice	Same
Sterilization	Steam (ISO17665-1)	Steam (ISO 17665-1)	Same as thesubject device	Same as the subjectdevice	Same
Planning Software	Neocis PlanningSoftwareApplication v2.0(K202264)	Same as theSubject Device	Same as theSubject Device	Same as the SubjectDevice	Yomi Plan v2.0cleared underK202264.SE under K161399
TechnologicalCharacteristics	NGS with IOFASubject Device	K161399Predicate	K200348FASReference Device	K202100C-CPSReference Device	SE Analysis
Software Level ofConcern	Moderate	Same as theSubject Device	Same as theSubject Device	Same as the SubjectDevice	Same

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The design changes in this submission involve adding a new Intraoral Fiducial Array (IOFA), which is a modified version of the Fiducial Array. The IOFA is a separate part that mounts to the Clamped Chairside Patient Splint (C-CPS) and contains fiducial markers for registration in CBCT scans prior to surgery. The IOFA is intended to sit intra-orally, which allows for use smaller field of view CT scanners. We have implemented the same affixation methods and technology as the predicate device. We have adopted the same indications for use as the predicate device.

We think that the subject device:

Has a legally marketed predicate, .
. Has the same intended use as the predicate,
Has somewhat different technological characteristics that do not raise different questions of safety and effectiveness, ●
For which we have provided adequate performance testing to show that ●
· Those different technological characteristics are substantially equivalent to the predicate device.

Therefore, the subject device is substantially equivalent.

{19}------------------------------------------------

VIII. 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:

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 -- Moistheat -- 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 - Part5: 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
Center for Devices and Radiological Health (CDRH)(2015). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff (FDA Amended June 9, 2017)

Verification

. Registration Testing
Autoclave Cycle Testing
Kinematic Mount Repeatability
Scan Artifact Testing
Fit Clearance Simulation
Total System Accuracy
IOFA Deflection Test

Validation

. IOFA End User Validation
- To validate the user requirements of the Intraoral Fiducial Array, as performed by a surgeon (end user). This validation activity is a nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a Intraoral Fiducial Array directly to a patient.

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

Conclusion:

The IOFA is substantially equivalent to the predicate. There are no changes to the intended use or to the fundamental technology, and there are no new risks to patients or users.

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.