Yomi is a computerized robotic 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 robotic navigational guidance of the surgical instruments. Yomi is intended for use in partially edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

Device Description

The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Metric	Reported Device Performance (YomiPlan Go)	Predicate Device Performance (NGS with YomiPlan v2.0)	Freehand Surgery Performance (Varga, et al, 2020)
Precision	Upper 95% Probability with 95% Model Fit < 1.00 mm	Upper 95% Probability with 95% Model Fit < 1.00 mm	Not specified directly, but YomiPlan Go offers improved precision over freehand.
Accuracy	N/A (not a specification or advantage for YomiPlan Go)	Upper 95% Probability with 95% Model Fit < 1.00 mm	Not a formal metric, but indirect comparisons are made.
Depth Error (mm)	1.38 +/- 0.71	Not directly provided for comparison in summary table	Not specified in this document for direct comparison
Lateral Error (mm)	2.04 +/- 1.59	Not directly provided for comparison in summary table	Not specified in this document for direct comparison
Angular Error (degs)	12.91 +/- 7.56	3.3° (from conclusion for predicate performance)	7.03° (average), 0.7–21.3° (range)
Human Factors (user needs)	Met design and performance requirements (qualitative survey)	Not applicable as this is a new feature	Not applicable
Safety	No vital anatomical structure concerns (3rd party clinical review)	Not applicable as this is a new feature	Considered acceptable for healthy patients with adequate bone
No Serious Adverse Events	Confirmed in clinical study (except for one minor event related to user error)	Not applicable as this is a new feature	Not applicable

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

Sample Size: 44 implants placed in 15 patient arches.
Data Provenance: Prospective, multi-center, single-arm study (G210363) involving partially or fully edentulous patients. The study was conducted clinically with actual patients. The specific country of origin is not explicitly stated, but the submission is to the US FDA, implying it would be relevant to US practice.

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

Number of Experts:
- 3 investigators (general dentists) who performed the procedures.
- 1 independent 3rd party oral surgeon who performed an independent clinical assessment of all 15 cases.
Qualifications of Experts:
- Investigators: General dentists.
- Independent Assessor: 3rd party oral surgeon. Specific years of experience are not mentioned for any of the experts.

4. Adjudication Method for the Test Set:

The text describes case-by-case feedback from investigators (through CRF feedback) and an independent 3rd party clinical review of all 15 cases. This suggests a form of independent review rather than a strict 2+1 or 3+1 consensus process among multiple readers for ground truth establishment. Agreement between these groups (investigators' safety feedback, 3rd party review), especially regarding "no vital anatomical structure concerns," served as a form of "ground truth" for clinical safety and acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of evaluating human readers with and without AI assistance.
The study primarily focused on the standalone performance of "YomiPlan Go" relative to freehand techniques and comparison metrics with the predicate device. The "human factors" evaluation was for the new YomiPlan Go workflow itself by the operating surgeons, not a comparison of human interpretation/performance with and without AI.
The benefits assessment does highlight how YomiPlan Go assists surgeons (e.g., depth stop, prevention of skiving, parallelism, precision in repeated drilling), which could be interpreted as improving human performance, but this wasn't quantified through an MRMC study design measuring specific effect sizes of human improvement.

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

Yes, in part, a standalone assessment of the algorithmic component's performance (precision, depth, and lateral error) was conducted as a secondary objective of the clinical study, comparing pre-operative plans (ideal locations) to post-operative implant placement.
The system's precision specification (Upper 95% Probability with 95% Model Fit < 1.00 mm) is also mentioned as supported by benchtop verification testing, which would typically be a standalone performance test. However, the accuracy is explicitly stated as "N/A for YomiPlan Go" as it's not a specification for this specific mode, which relies on the surgeon's real-time visual assessment rather than a pre-loaded CT.

7. The Type of Ground Truth Used:

The ground truth for the performance metrics (depth, lateral, and angular error) was established by comparing preoperative clinical plans (ideal planned implant locations on CBCT scans) with postoperative CBCT scans capturing the actual placement of implants.
For clinical safety and acceptability, the ground truth was based on the assessment and feedback from the investigators and an independent 3rd party oral surgeon, specifically their confirmation of "no vital anatomical structure concerns."

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for the training set for the Yomi or YomiPlan Go system. The focus of this submission is on the clinical validation of a new feature (YomiPlan Go) for a previously cleared device.

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

The document does not provide information on how the ground truth for the training set was established. Since the details of the training set size or methodology are not given, the ground truth establishment method for it is also absent.

Summary

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Neocis Inc. William Tapia VP RA/QA 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K211466

Trade/Device Name: Yomi Robotic System with YomiPlan Go Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: PLV Dated: May 20, 2022 Received: May 20, 2022

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) K211466

Device Name Yomi Robotic System with YomiPlan Go

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)

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510(k) Summary K211466

l. Submitter

Neocis Inc.

2800 Biscayne Blvd.

Suite 600

Miami, FL 33137

Tel: 1-855-9NEOCIS

Contact Person: William Tapia, VP RA/QA

Date Prepared: June 14, 2022

II. Device

Trade Name: Yomi Robotic System with YomiPlan Go

Common Name: Dental Stereotaxic Instrument

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

Classification: Class II

Product Code: PLV

lll. Predicate Device

Neocis Guidance System (NGS) with YomiPlan v2.0 (K202264)

IV. Reference Device

Orthosoft Navitrack System-Optical TKR CT-Less System (K021760)

V. Indications for Use

VI. Device Description

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planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.

Principal of Operation

YomiPlan Go gives surgeons the ability to place implants on the trajectory defined by the axis and location of the robotic arm drill tip for any selected implant, without the use of a preoperative CT scan uploaded to the Yomi System. This feature allows surgeons to place implants with precision without a preloaded CT scan. With YomiPlan Go, the surgeon selects the implant and then creates the desired path for the planned osteotomy by positioning the robotic arm drill tip at the site of where the osteotomy is to be performed.

Intended Patient Population

Based on a clinical study performed with YomiPlan Go (G210363), the intended population for YomiPlan Go was determined to be:

. Healthy adults 18 years of age or older with sufficient bone height and width appropriate for dental implant surgery
Partially or fully edentulous patients ●

Preplanning with YomiPlan Go

Preplanning with YomiPlan Go is similar to that of traditional freehand technique as no CT image is actively referenced within YomiPlan. It is important to note that this does not preclude the surgeon from taking a pre-operative image and using it mentally as consideration for the freehand planning. The surgeon uses the system to indicate the plan on the patient by observing the patient's specific anatomy that is plainly visible.

The clinical study performed via G210363 demonstrated that YomiPlan Go could be used to successfully capture the trajectory of the osteotomy based mainly on the drill bit tip established by the surgeon and was adequate to provide placement of the implant at the position determined by the surgeon. In the study, YomiPlan Go was able to provide guidance which used a single point with a trajectory and resulting in placement of the implant at the position established by the surgeon.

Labeling for YomiPlan Go

Labeling (i.e., instructions for use, training) is an important part of YomiPlan Go. The following are key points from these materials:

. We recommend preoperative CT as standard of care for consultation and diagnosis. No imaging is required by Yomi Go software for preoperative planning or intraoperative guidance.
. Accuracy is not a specification or an advantage of YomiPlan Go, however precision is an important specification which has been validated through performance testing.
. The surgeon must use clinical judgment in determining the best plan (position, angle, and depth) based on any anatomy that is plainly visible as well as any pre-operative X-rays or CT they may have taken of the patient.
Use of YomiPlan Go vields less position accuracy relative to a CBCT than the guided technique for osteotomy placement in which CBCT scanning and digital intraoral impressions are used

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to generate a virtual representation of the patient's jaw and oral anatomy, and the exact position of the implant is determined in advance of treatment.

Use of Anatomical Cues to Define Trajectory

The implant position and angle are defined by the surgeon by using the drill tip as a pointer. This enables the surgeon to indicate to the system the desired position and angle based on any anatomical cues they believe are relevant, e.g., neighboring teeth, bone ridge, extraction socket, etc. It is up to the surgeon to plan the implant appropriately based on the patient's clinical condition and rely on their medical training and ability to visualize the relevant anatomy of the patient.

VII. Substantial Equivalence Discussion

The table below summarizes a comparison of YomiPlan Go with the predicate NGS with Yomi Plan 2.0 (K202264).

	Subject Device	Predicate Device
Feature	Yomi Robotic System with YomiPlan Go	NGS with Yomi Plan v2.0	SE Analysis
	K211466	K202264
Indications for use	Yomi is a computerized robotic navigational systemintended to provide assistance in both the planning(pre-operative) and the surgical (intra- operative)phases of dental implantation surgery. The systemprovides software to preoperatively plan dentalimplantation procedures and provides roboticnavigational guidance of the surgical instruments.Yomi is intended for use in partially edentulous andfully edentulous adult patients who qualify for dentalimplants.	The Neocis Guidance System (NGS) is acomputerized navigational system intended toprovide assistance in both the planning (pre-operative) and the surgical (intra-operative)phases of dental implantation surgery. Thesystem provides software to preoperativelyplan dental implantation procedures andprovides navigational guidance of the surgicalinstruments. The NGS is intended for use inpartially edentulous and fully edentulous adultpatients who qualify for dental implants.	Equivalent - Updated toinclude reference torobotic arm.
	When Yomi Plan software is used for preplanning onthird party PCs, it is intended to perform theplanning (pre-operative) phase of dentalimplantation surgery. Yomi Plan provides pre-operative planning for dental implantationprocedures using the Yomi Robotic System. Theoutput of Yomi Plan is to be used with the YomiRobotic System.	When Yomi Plan software is used forpreplanning on third party PCs, it is intendedto perform the planning (pre-operative) phaseof dental implantation surgery. Yomi Planprovides pre- operative planning for dentalimplantation procedures. The output of YomiPlan is to be used with the Neocis GuidanceSystem (NGS).
Contraindications	Most surgical dental implant placement involvesthree-dimensional placement into a non-visiblespace. Two-dimensional radiographs may provideimportant information, but they often lack the oral-facial dimension that completes the picture. more-detailed information from 3D x-ray imaging isneeded, most frequently, CBCT imaging.Complications in implant dentistry are common andcan range from minor to severe. One of the mostcommon complications in implant dentistry isimplant malposition. This can result in a host ofcomplications: fenestrations, dehiscences andrecession, difficult restoration, poor biomechanics,loss of interproximal structure, damage to adjacent	None	Different - differencevalidated as acceptablewith successfulcompletion of G210363
	Subject Device	Predicate Device
Feature	Yomi Robotic System with YomiPlan Go	NGS with Yomi Plan v2.0	SE Analysis
	K211466	K202264
	anatomy, and many others.
	Use of the YomiPlan Go is contraindicated when theintended implant location has concerns related tobone volume, architecture, and proximity to criticalanatomic structures, such as nerves, maxillary sinusor nasal floor or neurovasculature.
OS	Windows 10	Windows 10	Identical
PC Requirements	PC with 64-bit Windows 10 OS or newer with aminimum of 4 GB of RAM and a 2 GHz dual coreprocessor. Local memory (hard drive) should be aminimum of 100 GB with 7200 RPM or SSD.Connectivity requirements include ethernet, Wi-Fi,USB, or CD drive.	PC with 64-bit Windows 10 OS or newer witha minimum of 4 GB of RAM and a 2 GHz dualcore processor. Local memory (hard drive)should be a minimum of 100 GB with 7200RPM or SSD. Connectivity requirementsinclude ethernet, Wi-Fi, USB, or CD drive.	Identical
Preplanning Steps	Preplanning is performed by the surgeonby direct visualization of the patient'sanatomy and placing the drill tip at thedesired location and angle. The dimensionof the implant is identified in YomiPlan Goand the trajectory established by thesurgeon is captured.	The predicate device uses apreoperative CBCT scan which isuploaded to YomiPlan to supporta surgeon's planning of the desiredimplant placement.	Equivalent
Level of Concern	Moderate	Moderate	Identical
Installation	Windows Installer .msi file	Windows Installer .msi file	Identical
Origin	Proprietary	Proprietary	Identical
OTS Software	TeamViewer	TeamViewer	Identical
Hardware	No changes (activate/use pre-existing networkfeatures)	No changes (activate/use pre-existingnetwork features)	Identical
Wireless datatransmission overLAN	Yes, via integrated hardware, tested according to:AAMI TIR69: 2017 Technical InformationReport Risk management of radio-frequency wireless coexistence formedical devices and systems. IEEE ANSI C63.27-2017 American NationalStandard for Evaluation of WirelessCoexistence	Yes, via integrated hardware, testedaccording to: AAMI TIR69: 2017 TechnicalInformation Report Riskmanagement of radio-frequencywireless coexistence for medicaldevices and systems. IEEE ANSI C63.27-2017 AmericanNational Standard for Evaluation ofWireless Coexistence	Identical
Interface	Windows based GUI	Windows based GUI	Identical
System Accuracy /PrecisionSpecifications	Accuracy: N/A for YomiPlan GoPrecision: Upper 95% Probability with 95% ModelFit < 1.00 mm	Accuracy: Upper 95% Probability with 95%Model Fit < 1.00 mmPrecision: Upper 95% Probability with 95%Model Fit < 1.00 mm	SubstantiallyEquivalent -specifications forprecision are the same.Differencesdetermined to notsignificantly impactoverall SE profile ofYomiPlan Go as validated by successful
Feature	Subject DeviceYomi Robotic System with YomiPlan GoK211466	Predicate DeviceNGS with Yomi Plan v2.0K202264	SE Analysis
			completion ofG210363.

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To support the difference in technological characteristics of preoperative planning without the need to upload a CT image substantial equivalence of this characteristic is comparable to Orthosoft Navitrack System-Optical TKR CT-Less System (K021760):

Yomi Robotic System with YomiPlan Go VS Reference Device
Features Related toPreplanning the	Yomi Robotic Systemwith YomiPlan Go	Orthosoft CT-Less	Why Differences Do NotAffect SE
Trajectory/Implant Position	None entered in the software.The surgeon may optionallytake an X-ray or CT and usethat mentally during theprocedure.	None entered in the software.The surgeon may optionallytake an X-ray or CT and usethat mentally during theprocedure.	SAME
Preoperative Imaging	None entered in the software.The surgeon may optionallytake an X-ray or CT and usethat mentally during theprocedure.	None entered in the software.The surgeon may optionallytake an X-ray or CT and usethat mentally during theprocedure.	SAME
Intraoperative Planning	No CT is used for guidanceduring surgery	No CT is used for guidanceduring surgery	SAME
Image Registration andFiducial Markers	There is no image registrationand there are no fiducialmarkers because there is noimage to register to.	There is no image registrationand there are no fiducialmarkers because there is noimage to register to.	SAME
Intraoperative DataGathering for Planning	The surgeon observes thephysical location, e.g.,neighboring teeth, bone (ifflapped), soft tissue, etc.	Since the surgeon cannotvisibly observe all theanatomical landmarksnecessary for planning, theycapture coordinate systemelements through pointdigitization, e.g. hip center,knee landmarks, etc., to guidetheir planning. The datagathered is mapped to ageneric image, but this is stillvery dissimilar from what theactual CT would be.	Equivalent - Neither systemincorporates preoperativepatient specific imaging forplanning. Both rely on patientspecific data either observedor captured with calculationsto finalize the planintraoperatively.

Benefit / Risk Analysis

The FDA Guidance Document entitled "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics" was reviewed to prepare the following benefit/risk discussion in order to support the claim of substantial equivalence.

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Primary DifferencesBetween Predicateand Subject Device	1. Planning: Planning is based on the user's own direct visual examination of the patient's anatomy guided by the YomiGuide Arm. Predicate device planning is based on both a patient-specific CT scan and direct visual examination.2. Osteotomy: With YomiPlan Go, there is no CT scan to reference while performing the osteotomy. The predicate devicepresents the CT scan to the user which can then be used as reference during the osteotomy. All other aspects ofperforming the osteotomy are the same when comparing YomiPlan Go to the predicate device.3. YomiPlan Go IDE data from G210363 showed that the average angular deviation was higher with YomiPlan Go. Thestudy also showed that the range of angular deviations from the IDE was within the range of angular deviations fromthe Varga, et al study for freehand (see Varga article reference below).
Assessment ofBenefits	Benefits compared to the predicate device:1. YomiPlan Go can enable a faster workflow and greater adoption of guided surgery.2. YomiPlan Go does not require a pre-operative CT scan therefore clinician and staff and patient exposure to x-rays isreduced.Benefits compared to freehand surgery:1. YomiPlan Go provides a depth stop. This prevents over drilling, which can happen accidentally in freehand surgery.2. By holding the drill steady, YomiPlan Go prevents skiving, i.e. slipping off of a knife-edge ridge of bone or slipping into aextraction socket or into soft bone.3. It enables precision throughout repeated drill stages of multiple diameter drill bits. YomiPlan Go guides the user to thesame position and angle even after switching drill bit diameters as they proceed through drilling the osteotomy. Thisprecision is not easy to achieve with a freehand surgery technique.4. YomiPlan Go enables parallelism.5. YomiPlan Go provides guidance without the workflow burdens of CT image capture, registration, and pre-planning.
Assessment ofRisks Related toDifferences	1. Use of Yomi Active does present some risk associated with lack of use of a CT scan in the identification and protection ofcritical anatomical structures. Potential harms related to Yomi Active includes potential damage to themaxillary/mandibular nerves (temporary or permanent in duration depending on case). However, the risks associatedwith not using a CT scan uploaded to the Yomi System are considered to be similar to current freehand technique. Sincefreehand is considered by many to be the standard of care today in healthy patients with adequate bone, the risk isconsidered acceptable.2. Critical structures are still protected with YomiPlan Go constraining the drill position and angle to match the plan set bythe surgeon. It creates a depth stop and prevents skiving into unintended areas. The difference is that the plan does notuse CT reference in the software, but the surgeon still has the ability to observe physically where they want the implantto be placed, and they also have the option to capture a pre-operative X-ray or CT and use it for "mental navigation" ofthe planning.3. Any false sense of accuracy and appropriate position of the implant that the user may infer from the use of Yomiwith CT-based guidance is mitigated with labeling e.g., instructions for use update to include appropriate warnings,marketing materials to also clearly differentiate between benefits and risks associated with using YomiPlan Go andYomi CT-Guided, and a training program which includes materials outlining the above as well.4. The difference in average angular deviation was found to be acceptable as evidenced by the CRF feedback from the(3) investigators after their completion of each case and by the (1) independent 3rd party clinical review of all 15 cases from the IDE i.e., feedback from the investigators that they had no vital anatomical structure concerns after completion of each procedure.

Primary DifferencesBetween Predicateand Subject Device

1. Planning: Planning is based on the user's own direct visual examination of the patient's anatomy guided by the YomiGuide Arm. Predicate device planning is based on both a patient-specific CT scan and direct visual examination.2. Osteotomy: With YomiPlan Go, there is no CT scan to reference while performing the osteotomy. The predicate devicepresents the CT scan to the user which can then be used as reference during the osteotomy. All other aspects ofperforming the osteotomy are the same when comparing YomiPlan Go to the predicate device.3. YomiPlan Go IDE data from G210363 showed that the average angular deviation was higher with YomiPlan Go. Thestudy also showed that the range of angular deviations from the IDE was within the range of angular deviations fromthe Varga, et al study for freehand (see Varga article reference below).

Assessment ofBenefits

Benefits compared to the predicate device:1. YomiPlan Go can enable a faster workflow and greater adoption of guided surgery.2. YomiPlan Go does not require a pre-operative CT scan therefore clinician and staff and patient exposure to x-rays isreduced.Benefits compared to freehand surgery:1. YomiPlan Go provides a depth stop. This prevents over drilling, which can happen accidentally in freehand surgery.2. By holding the drill steady, YomiPlan Go prevents skiving, i.e. slipping off of a knife-edge ridge of bone or slipping into aextraction socket or into soft bone.3. It enables precision throughout repeated drill stages of multiple diameter drill bits. YomiPlan Go guides the user to thesame position and angle even after switching drill bit diameters as they proceed through drilling the osteotomy. Thisprecision is not easy to achieve with a freehand surgery technique.4. YomiPlan Go enables parallelism.5. YomiPlan Go provides guidance without the workflow burdens of CT image capture, registration, and pre-planning.

Assessment ofRisks Related toDifferences

1. Use of Yomi Active does present some risk associated with lack of use of a CT scan in the identification and protection ofcritical anatomical structures. Potential harms related to Yomi Active includes potential damage to themaxillary/mandibular nerves (temporary or permanent in duration depending on case). However, the risks associatedwith not using a CT scan uploaded to the Yomi System are considered to be similar to current freehand technique. Sincefreehand is considered by many to be the standard of care today in healthy patients with adequate bone, the risk isconsidered acceptable.2. Critical structures are still protected with YomiPlan Go constraining the drill position and angle to match the plan set bythe surgeon. It creates a depth stop and prevents skiving into unintended areas. The difference is that the plan does notuse CT reference in the software, but the surgeon still has the ability to observe physically where they want the implantto be placed, and they also have the option to capture a pre-operative X-ray or CT and use it for "mental navigation" ofthe planning.3. Any false sense of accuracy and appropriate position of the implant that the user may infer from the use of Yomiwith CT-based guidance is mitigated with labeling e.g., instructions for use update to include appropriate warnings,marketing materials to also clearly differentiate between benefits and risks associated with using YomiPlan Go andYomi CT-Guided, and a training program which includes materials outlining the above as well.4. The difference in average angular deviation was found to be acceptable as evidenced by the CRF feedback from the(3) investigators after their completion of each case and by the (1) independent 3rd party clinical review of all 15 cases from the IDE i.e., feedback from the investigators that they had no vital anatomical structure concerns after completion of each procedure.

VIII. Nonclinical Performance Testing

This submission includes certain nonclinical performance testing including verification (software run-through, repeatability) and end user validation to confirm that users' needs have been satisfied while using Yomi with YomiPlan Go. End user validation was performed by a surgeon in a simulated use environment on typodonts.

IX. Clinical Testing

A clinical study (G210363) was performed in order to support substantial equivalence of YomiPlan Go to the predicate device. The primary objective of this study was to evaluate human factors related issues with YomiPlan Go during the preoperative and intraoperative use with the

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Image /page/9/Picture/0 description: The image shows the logo for Neocis. The logo features the word "neocis" in a sans-serif font, with the letters in yellow. Above the word is a gray horizontal line that extends to the left and right of the word. There is a gray vertical line that intersects the horizontal line at the center of the word, forming a cross shape.

Yomi Robotic System. The secondary objective focused on evaluating accuracy of the YomiPlan Go. This included a comparison of pre-operative CBCT scans on which implants are planned in ideal locations with postoperative CBCT scans capturing the actual placement of implants placed clinically with the YomiPlan Go. It also included a third-party oral surgeon's assessment regarding safety to ensure no critical structures are damaged, an evaluation for parallelism for implants that are to be placed parallel to one another, and an assessment of restorability. The information from this study was used to guide device modifications with particular focus on informing changes to the device labeling/instructions for use to ensure appropriate use of the YomiPlan Go.

The investigation was a prospective, multi-center, single-arm study, in which partially or fully edentulous patients had as part of their treatment single or multiple implant placement in the maxilla or the mandible. The subjects enrolled in the study had to satisfy certain inclusion criteria:

Age more than 18 years at inclusion
Signed informed consent
. Partially or fully edentulous patients that will have implant placement in the maxilla or the mandible as part of their treatment
. Must have sufficient bone height and width appropriate for dental implant surgery as evaluated on a Cone Beam Computed Tomography (CBCT) survey

A total of 44 of implants were placed in fifteen (15) patient arches with Yomi Active. Each of the (5) sites had (3) partial and (2) full arch dental restorations performed by each investigator. The study was performed by general dentists. A 31d party oral surgeon performed an independent clinical assessment of all cases.

Each investigator provided subjective data through completion of quantitative and open-ended subjective questionnaires. There were also no serious adverse events during the conduct of this clinical study. Overall, according to the qualitative survey, the investigators determined that the YomiPlan Go met its design and performance requirements.

An adverse event did occur with one subject where the implant was transported into the sinus during hand torquing. The surgeon placed another implant to complete the dental restoration at the tooth site and completed an intervention on a later date to remove the implant. The surgeon documented on the CRF the severity of this event as "minor" and an unlikely relationship to Yomi Active. Per the surgeon, the robot was able to maintain the reference point for the osteotomy protocol that followed the initial osteotomy. After further Neocis investigation, root cause of this event was related to user error due to the surgeon hand torquing the implant deeper.

YomiPlan Go accuracy was also assessed by comparing the preoperative plans to their respective post-operative implant placement. The precision, depth and lateral error of the YomiPlan Go is equivalent to the predicate. Angular deviations were higher with YomiPlan Go than with the predicate device (see summary table below).

Comparison Metric	Raw Data of Implant Placements Grouped by Patient, Absolute Values,reported in Mean/StdDev
	Depth Error (mm)	Lateral Error (mm)	Angular Error (degs)

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Image /page/10/Picture/0 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in yellow. A gray line is above the word. To the right of the word is a gray circle with a vertical and horizontal line through it.

Investigator Plan on PreOp CT vs InvestigatorPostOp CT of Final Implant Placement	1.38 +/- 0.71	2.04 +/- 1.59	12.91 +/- 7.56
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These results were found to be within a similar range to freehand accuracy data. However, accuracy is not a specification or an advantage of YomiPlan Go, whereas precision is a specification for the system and is supported by benchtop verification testing.

Supporting Clinical References X.

The angular accuracy of the YomiPlan Go is higher than the predicate. To support the difference in performance the following articles provide support regarding performance between YomiPlan Go as compared to freehand technique:

. Dynamic Navigation for Dental Implant Surgery, Penchal, et al, Oral Maxillofac Surq Clin North Am, Nov, 2019 – In line with this article, YomiPlan Go provides a better balance of guidance and workflow disruption. YomiPlan Go provides guidance without the workflow burdens of CT image capture, image registration, and pre-planning.
. Digital Implant Planning and Guided Implant Surgery - Workflow and Reliability, Schubert, et al, BR Dent J, Jan 2019 – This article discussed ideal workflows and improved reliability during guided implant surgery. In line with this article, YomiPlan Go does not require a pre-operative CT scan therefore clinician and staff and patient exposure to xrays is avoided.
. Evaluating the Health Economic Implications and Cost-Effectiveness of Dental Implants: A Literature Review, Vogel, et al, Int J Oral Maxillofac Implants, Mar-April 2013 – This article discusses the positive economic implications of more patients having access to dental implant surgery. Since YomiPlan Go does not require a CT scan, general dentists who perform this procedure in a freehand manner, their patients, and thus in general health economics, could all benefit with YomiPlan Go.
. Factors Influencinq the Accuracy of Freehand Implant Placement: A Prospective Clinical Study, Schnutenhaus S, et al, Dent J (Basel), May, 2021 - Risks associated with YomiPlan Go can be considered similar to current freehand technique. Since freehand is considered by many to be the standard of care today in healthy patients with adequate bone, the risk associated with YomiPlan Go is considered acceptable. This article supports this conclusion. Schnutenhaus S, et al, also included a reference to a randomized clinical study by Varga E, et al (i.e., Varga E., Jr., Antal M., Major L., Kiscsatari R., Braunitzer G., Piffko J. Guidance means accuracy: A randomized clinical trial on freehand versus guided dental implantation. Clin. Oral Implant Res. 2020), where the deviations resulting from freehand implant placements and the various implant placements with the aid of drilling templates were compared. They found an average angular deviation of 7.03° in a freehand procedure with a range of 0.7–21.3°.
Image Guidance for Implants Improves Accuracy and Predictability, Compendium of CE in Dentistry, Ganeles, et al, Nov/Dec 2011 – The article discussed how surgeons have the option to capture a pre-operative X-ray or CT and use it for "mental navigation" of the planning. This is similar to how a preoperative image would be used with YomiPlan Go.

XI. Conclusion

The substantial equivalence discussion, risk profile comparisons, and testing described above demonstrate that YomiPlan Go and the predicate device have many similarities and can be

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Image /page/11/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in yellow. Above the word is a gray line that extends to the left and right of the word. There is a gray circle above the "c" in "neocis" with a vertical line extending upwards and a horizontal line extending to the right.

considered similar. There were some differences noted with the clinical test data such as the difference in the performance of the predicate (angular deviation of 3.3°) to the performance of the subject device (angular deviation of 12°) and performance of freehand (angular deviation range of up to 21°). These differences were found to be acceptable as evidenced by the CRF feedback from all (3) investigators after their completion of each case and by the (1) independent 3rd party clinical review of all 15 cases from the IDE i.e., feedback from the investigators was that they had no vital anatomical structure concerns after completion of each procedure. Also, when weighing the benefits (e.g., faster workflows when YomiPlan Go is indicated; less radiation exposure) against any risks associated with YomiPlan Go (e.g., less accuracy and pre-planning of critical structures, does not require the use of a preloaded CT scan onto the Yomi system for planning), it was concluded that YomiPlan Go is substantially equivalent to the predicate device.

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.