The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

Device Description

The Neocis Guidance System (NGS) (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 accurate navigational guidance of surgical instruments, with regard to pre-operative 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 surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS 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 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 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 device is a design variation of the predicate CPS (K173402). The portion of the splint that attaches to the patient now contains the fiducial markers. We are calling the subject device, the Fiducial Array Splint (FAS). This provides an alternative workflow in which the FA is not needed. These are the only changes in this submission. The NGS is otherwise the same as the cleared device (K161399). The indications for use and contraindications for the subject and predicate devices are the same.

Since the fiducial markers are on the portion of the splint that is affixed using dental material, we do have to limit the use of cleared dental materials (K182776) to those that are not radioopaque:

3M ESPE ProTemp Plus
Alike
Traid C&B Material (UV light curable)

The other dental materials cleared for use with the CPS cannot be used with the FAS.

Since the FAS does need the FA, we can use the FAS in CBCT scanners with smaller scan volumes and standard chin rests.

AI/ML Overview

The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is a computerized navigational system for dental implantation surgery. This 510(k) submission (K200348) describes a design variation to the patient tracking portion of the NGS, specifically the Fiducial Array Splint (FAS). The primary change is the integration of fiducial markers directly into the splint, eliminating the need for a separate Fiducial Array (FA).

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in numerical terms. Instead, it states that "Our performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate device." The "SE Analysis" column in Table 1 generally indicates "Identical," "Additional radio-transparent dental materials from reference device K182776," "Fiducial beads relocated to the FAS," and "Simpler interface, less parts." These are characteristic-level comparisons rather than quantitative performance metrics against specific acceptance criteria.

The document indicates that additional Neocis Performance Testing was conducted, including:

Bite force testing on fiducial markers
Cut removal
Loaded splint deflection testing using 2x PT weight
Simulated clinical use: end user validation on a typodont
Fiducial marker registration
Fiducial marker single use autoclave test
Total system accuracy testing

While these tests were performed to demonstrate substantial equivalence, the specific quantitative acceptance criteria for each test and the corresponding performance results are not detailed in this document. The conclusion states that performance testing "demonstrates substantially equivalent performance," implying that any defined acceptance criteria for these tests were met.

Study Details

The provided document describes a validation study for the newly designed Fiducial Array Splint (FAS) in comparison to the predicate Chairside Patient Splint (CPS) (K173402).

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of patients or experimental runs for each performance test. The document mentions "Simulated clinical use: end user validation on a typodont," which indicates a phantom-based testing approach.
- Data Provenance: The study was conducted by Neocis Inc. The document does not specify the country of origin for the data or whether the study was retrospective or prospective, but given it's an end user validation on a typodont, it's a prospective, in-house validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "Simulated clinical use: end user validation on a typodont" implies that dental professionals would be involved in using the device and evaluating its performance, but the number and qualifications of these "end users" are not detailed.
Adjudication method for the test set: Not explicitly stated.
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: Not applicable. This device is a Guidance System for surgical procedures, not an AI-assisted diagnostic or interpretive tool where "human readers" or "cases" in the MRMC sense would typically apply. The focus is on the accuracy and safety of surgical instrument guidance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Total system accuracy testing" and other performance tests likely involved assessing the device's accuracy and functionality in a simulated environment, which could be considered standalone testing of the underlying guidance system's physical and software components. However, the "Simulated clinical use: end user validation" implies human-in-the-loop testing as well.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For performance tests on a typodont model, the ground truth would typically be established by precise measurements of the planned versus actual implant trajectory/osteotomy, using high-precision measurement tools (e.g., CMM, optical tracking systems) to determine deviations from the pre-planned positions. This is a form of engineering measurement against a defined plan rather than expert consensus on a diagnosis or pathology.
The sample size for the training set: Not applicable. This document describes the validation of a physical medical device and its associated software for surgical guidance, not a machine learning algorithm that requires a "training set" for model development.
How the ground truth for the training set was established: Not applicable, as there is no mention of an AI model requiring a training set in this context.

Summary

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May 8, 2020

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

Re: K200348

Trade/Device Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: February 11, 2020 Received: February 12, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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

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Indications for Use

510(k) Number (if known) K200348

Device Name

Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)

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 CER 801 Subnart C)

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Submitter Name:

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

Contact Person:

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

Date Prepared: May 7, 2020

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

Common Name: Dental Stereotaxic Instrument

Classification Name: Bone cutting instrument and accessories (21 CFR 872.4120)

Classification: Class II

Product Code: PLV

Primary Predicate Device: Neocis Guidance System (NGS) with Chairside Splint (K173402)

Reference Devices: Neocis Guidance System (K191605) & Neocis Guidance System (K182776)

Indications for Use:

Device Description:

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regard to pre-operative 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.

Since the fiducial markers are on the portion of the splint that is affixed using dental material, we do have to limit the use of cleared dental materials (K182776) to those that are not radioopaque:

3M ESPE ProTemp Plus
Alike
Traid C&B Material (UV light curable)

The other dental materials cleared for use with the CPS cannot be used with the FAS.

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Since the FAS does need the FA, we can use the FAS in CBCT scanners with smaller scan volumes and standard chin rests.

Comparison of Technological Characteristics:

This submission involves only a modification to the CPS, referred to as the FAS, to be differentiated from the other Neocis splints. Otherwise, all performance characteristics of the NGS are the same. The differences introduced by this modification are detailed in Table 1.

TechnologicalCharacteristics	Subject Device	Predicate K173402	SE Analysis
Indications forUse (IFU)	The Neocis Guidance System (NGS)is a computerized navigationalsystem intended to provideassistance in both the planning(pre-operative) and the surgical(intra-operative) phases of dentalimplantation surgery. The systemprovides accurate navigationalguidance of surgical instruments,with regard to pre-operativeplanning in dental implantationprocedures.	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phasesof dental implantation surgery.The system provides accuratenavigational guidance of surgicalinstruments, regarding pre-operative planning in dentalimplantation procedures.	Identical
Technology / Performance Characteristics
Power supply	120VAC/60Hz	120VAC/60Hz	Identical
SplintAttachmentUsing DentalMaterials	3M ESPE ProTemp Plus(K033022) Alike (K942670) Traid C&B Material (UVlight curable) (K850911) *Radio-opaque dental materialsnot recommended	Lang Jet Tooth Shade (K083195)	Additional radio-transparentdental materialsfrom referencedevice K182776
Splint Removal	FAS may be removed either bycutting bridges along a seam of thesplint or manually pulling off.	CPS may be removed either bycutting bridges along a seam ofthe splint or manually pullingoff.	Identical
Fiducial Array(FA)	Not required	The Fiducial Array attaches tothe splint during the CT scan toprovide a reference in theimage.	Fiducial beadsrelocated to theFAS
Kinematic Mount(KM)	KM integrated into the FAS	KM screwed to CPS and FA	Simpler interface,less parts

Table 1: SE Summary

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TechnologicalCharacteristics	Subject Device	Predicate K173402	SE Analysis
Splint Materials	IXEF-HC-1022 Aluminum 2017 Epoxy (EPO-TEK 353ND)	IXEF-HC-1022	Addition offiducial markerand adhesivematerials
Safety Features
Biocompatibility	Tissue, bone, dentin contact < 24 hrsISO 10993-1, -5, -10, -12	Tissue, bone, dentin contact < 24 hrsISO 10993-1, -5, -10, -12	Identical
Sterilization	Steam, by end user, reusableISO 17665-1	Steam, by end user, reusableISO 17665-1	Identical
Components
Patient TrackingDevice	Patient Tracker (PT) with EndEffector (EE)	Patient Tracker (PT) with EndEffector (EE)	Identical
Dental DrillMotor and HandPiece	Aseptico Drill Motor(Model No. AEU-7000LNE-70V) (K030163) Anthogyr Mont Blanchandpiece (AsepticoModel No. AHP-85MBFO-CX) (K070084)	W&H Implant MedElectric Drill Motor(Implant Med SI 95Series) Anthogyr Impulsionhandpiece (Model No.14400BP)	Brand change,functionallyequivalent(Reference DeviceK191605)
Drill MotorCollar	Geometry to fit Aseptico Increased size Compression collet toimprove rigidity	Geometry to fit W&H Smaller size Tension clamp forrigidity	Increasedrobustness of thedesign to improverigidity and toaccommodatedifferent drillbrand (ReferenceDevice K191605)
Other NGSTechnology	No changes	No changes	Identical
NGS Software(Planning andControl)	No changes	No changes	Identical

Performance Testing Submitted with this Submission:

Use of FDA-Recognized Consensus 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 -- 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:

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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

Additional Neocis Performance Testing

1. Bite force testing on fiducial markers
1. Cut removal
1. Loaded splint deflection testing using 2x PT weight
1. Simulated clinical use: end user validation on a typodont
1. Fiducial marker registration
1. Fiducial marker single use autoclave test
1. Total system accuracy testing

Conclusion:

There are no changes to the intended use of the subject device. Our performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate device. Therefore, the FAS 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.