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 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 NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS 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 splint 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 splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, 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 who qualify for dental implants.

AI/ML Overview

The provided text discusses the Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) and a design change to its sleeves. However, it does not contain a detailed study proving the device meets acceptance criteria for performance, especially not in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neocis Guidance System (NGS) with Patient Splints, K200805) after a design change to the EPS sleeves. The "Performance Testing" section lists various tests conducted, primarily related to the physical and biological aspects of the device, rather than a clinical performance study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not available in the provided text for a clinical performance study.

Here's what can be extracted and inferred from the text, focusing on the design change and the tests mentioned:

Acceptance Criteria and Device Performance (Design Change Validation)

The document describes a design change to the sleeves within the Edentulous Patient Splint (EPS) component of the Neocis Guidance System (NGS). The acceptance criteria are implicitly related to ensuring this design change does not negatively impact the safety and effectiveness of the device, and that it remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance/Conclusion
Mechanical Performance (Splint)	EPS Weighted Deflection Test with Optical Tracking in Sawbones®	Implied to have met predefined limits for deflection, ensuring stability and accuracy. The document states "The new design is functionally the same as the predicate device."
System Accuracy	Total System Accuracy	Implied to have met accuracy requirements (likely related to navigational guidance precision), ensuring the design change does not degrade the overall system's ability to guide surgical instruments accurately.
Risk Management	ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to medical devices	Risk analysis performed and controls implemented to mitigate risks associated with the design change. Concludes no new questions of safety or effectiveness.
Sterilization	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 device	Sterilization process validated for the new material/design.
Biocompatibility	ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process	Biological evaluation indicating the new materials (Neocis design titanium for sleeves, removal of stainless steel from patient-contacting materials) are safe for patient contact.
ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	No cytotoxicity detected.
ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	No irritation or skin sensitization detected.
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	No systemic toxicity detected.
ANSI AAMI ISO 10993-12: 2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials	Sample preparation and reference materials used were appropriate for the biocompatibility testing.
Conclusion of Substantial Equivalence (Overall System)	Overall, the design changes to the EPS sleeves have been verified using well-established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness.	The subject device is substantially equivalent to the predicate, meaning it is as safe and effective as the previously cleared device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for performance tests like "EPS Weighted Deflection Test" or "Total System Accuracy". These are typically engineering verification tests, and the "sample size" would refer to the number of units tested.
Data Provenance: Not specified for these engineering tests. "Sawbones®" is mentioned, indicating laboratory testing on synthetic bone models. This is not clinical data.

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

Not applicable for the reported tests. The tests are engineering verification tests, not diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication method for the test set:

Not applicable. See point 3.

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 study was mentioned or conducted. The device is a surgical guidance system, not a diagnostic AI tool for human readers.

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

Not explicitly described as a standalone algorithm performance study. The "Total System Accuracy" test would assess the device's accuracy in guiding the surgical instrument, which is its primary function (albeit with a human surgeon operating the instrument under guidance). The text focuses on the mechanical and system accuracy of the guidance mechanism itself, not a diagnostic algorithm.

7. The type of ground truth used:

For mechanical tests: Engineering specifications, precision measurements, or established physical benchmarks are the "ground truth."
For biological tests: Standards (e.g., ISO 10993) and established laboratory protocols define the "ground truth" for material properties and effects.

8. The sample size for the training set:

Not applicable. The document does not describe the development or training of an AI algorithm in the context of a "training set" for diagnostic performance.

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

Not applicable. See point 8.

Summary of Device Performance (from the document's conclusion):
The primary conclusion is that "The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate." This implies that all the listed performance tests were successfully passed, ensuring that the modified device remains as safe and effective as its predecessor.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

December 15, 2020

Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33317

Re: K203401

Trade/Device Name: Neocis Guidance System (NGS) with Patient Splints (EPS) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: November 18, 2020 Received: November 19, 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 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,

Michael Adjodha, M.ChE. Assistant 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) K203401

Device Name Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS)

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)
☑	☐

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}------------------------------------------------

Image /page/3/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. To the right of the word is a gray vertical line with a circle in the middle. The vertical line intersects the horizontal line.

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: November 18, 2020

II. Device

Trade Name:	Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS)
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

Neocis Guidance System (NGS) with Patient Splints (K200805) ●

IV. Indications for Use

V. Device Description

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

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 "neo" portion in a golden color and the "cis" portion in a gray color. Above the word is a gray horizontal line that extends over the "neo" portion and connects to a vertical line that extends down to the "cis" portion. There is a small circle at the intersection of the horizontal and vertical lines.

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.

VI. Comparison of Technological Characteristics

This submission includes a design change to the sleeves in the EPS. There are no changes to the indications for use. There are no changes to the NGS hardware or software in this submission. The differences introduced by this modification are detailed in Table 1.

TechnologicalCharacteristics	Subject Device	Predicate K200805	SE Analysis
Indications forUse (IFU)	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phases ofdental implantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidance ofthe surgical instruments. The NGSis intended for use in partiallyedentulous and fully edentulousadult patients who qualify fordental implants.	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phases ofdental implantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides navigational guidance ofthe surgical instruments. The NGSis intended for use in partiallyedentulous and fully edentulousadult patients who qualify fordental implants.	Identical
NGS Technology(non-splinthardware andsoftware)	No changes	No Changes	Identical
Patient Splint	EPS	EPS	Identical
Splint Sleeves	Neocis design titanium	Third party stainless steel(K190059)	Material &manufacturingchange
PatientContactingMaterials	● Ixef®-HC-1022● Titanium Alloy	● Ixef®-HC-1022● Stainless Steel● Titanium Alloy	Removedstainless steel
Patient Tracking	Physical linkage to patient viaPatient Tracker, Kinematic Mount,and End Effector connected to:● EPS	Physical linkage to patient viaPatient Tracker, KinematicMount, and End Effectorconnected to:● EPS	Identical

Table 1: Comparison of technological characteristics to the predicates

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

Image /page/5/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 horizontal gray line that extends over the "neo" portion of the word. To the right of the word is a gray crosshair symbol, with a small circle at the intersection of the lines.

TechnologicalCharacteristics	Subject Device	Predicate K200805	SE Analysis
Affixation oftrackingtechnology topatient	Stryker Mandibular Fractureand Reconstruction FixationSystem, Bone Fixation Screws2.0, 2.3 mm Diam, 10 – 20 mmlength (K014263)	Stryker Mandibular Fracture andReconstruction Fixation System,Bone Fixation Screws 2.0, 2.3 mmDiam, 10–20 mm length(K014263)	Identical
Patientattachmentremoval	EPS is removed by unscrewing thebone screws	EPS is removed by unscrewing thebone screws	Identical
Fiducials	Fiducial Array (FA) attached tosplint	Fiducial Array (FA) attached tosplint	Identical
Kinematic mount	Integrated into the splint	Integrated into the splint	Identical

VII. Performance Testing

The subject of this 510(k) was a design change to the sleeves in the EPS. There are no other system or labeling changes in this submission.

EPS Weighted Deflection Test with Optical Tracking in Sawbones®
Total System Accuracy
ANSI AAMI ISO 14971:2019 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 device
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
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
. ANSI AAMI ISO 10993-12: 2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials

VIII. Conclusion

The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device 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.