Yomi Robotic System 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. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. 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

In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDAcleared indications for use (K210711), the Yomi Robotic System 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 Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Yomi System allows the user to plan the surgery virtually in Yomi Plan, 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 for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDAcleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), 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 prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).

The subject of this submission is introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device is "substantially equivalent" to predicate devices, but it does not explicitly list specific acceptance criteria with numerical targets or thresholds. Instead, it focuses on demonstrating equivalence through various performance tests and comparisons.

Acceptance Criteria	Reported Device Performance
General Equivalence to Predicate Device: The device should perform comparably to legally marketed predicate devices for its intended use. (Implied acceptance criteria for 510(k) clearance)	Substantially equivalent to Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711) and reference to Mako Partial Knee Application (K142530). No fundamental changes to technology.
Safe and Effective Performance for Bone Reduction Feature: The new bone reduction feature should function as intended without introducing new safety or effectiveness concerns. (Implied)	Verification testing of the new handpiece and bur. Verification of bone reduction planning, visualization, and performance. Bone reduction accuracy verification. Full system cadaver validation. Human Factors Validation for Bone Reduction. Software End User Validation of Bone Reduction.
Software Functionality: The software user interface should function as intended. (Performance Testing, Section VII)	Software verification testing fully executed according to ANSI AAMI ISO 14971:2019, ANSI AAMI IEC 62304:2006/A1:2016, and FDA Guidance for Premarket Submissions and Software Validation.

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

Test Set Description: The document refers to "Full system cadaver validation" for both the primary predicate and the subject device (section V and Table 1). It also mentions "Human Factors Validation for Bone Reduction" and "Software End User Validation of Bone Reduction."
Sample Size: The exact sample size (number of cadavers, number of users for human factors/software validation) is not specified in the provided text.
Data Provenance: The cadaver validation implies use of human anatomical specimens, and "Human Factors Validation" suggests involving human users. The origin (e.g., country) of these cadavers or participants is not specified. The studies appear to be prospective in nature, as they involve testing the new feature.

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

This information is not provided in the text. The document mentions "surgeon plans" in the workflow description, implying clinical expertise, but it does not detail the involvement of experts in establishing ground truth for testing or validation purposes.

4. Adjudication Method for the Test Set:

This information is not provided in the text. There is no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating test results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not explicitly mentioned in the provided text. There is no information about human readers improving with or without AI assistance. The focus is on the robotic system's performance and substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document describes the Yomi Robotic System as a "computerized robotic navigational system intended to provide assistance in both the planning... and the surgical (intra-operative) phases." It explicitly states that the system "provides robotic navigational guidance of the surgical instruments" and "provides physical, visual, and audible feedback to the surgeon." This strongly indicates that the device is designed for human-in-the-loop operation, and therefore, a standalone (algorithm only) performance study would likely not be the primary focus or relevant to its intended use. The performance testing focuses on the system's accuracy and functionality within this assisted context.

7. Type of Ground Truth Used:

The document mentions "Bone reduction accuracy verification" and "Full system cadaver validation." This suggests that the ground truth for performance was established based on:

Physical measurements/direct observation on anatomical specimens (cadavers): For verifying the accuracy of bone reduction performed by the robot.
Planned surgical boundaries: The system guides based on a pre-operative plan, so the ground truth would be the accurately executed plan.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. This is typical for 510(k) submissions focusing on substantial equivalence for robotic-assisted surgical devices, which often rely on established engineering principles, verification, and validation rather than large-scale machine learning model training.

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

As no training set is mentioned, this information is not applicable/provided in the text.

Summary

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November 4, 2022

Neocis Inc. Olga Lewis Regulatory Affairs Director 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K222049

Trade/Device Name: Yomi Robotic System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: QRY, PLV Dated: October 13, 2022 Received: October 17, 2022

Dear Olga Lewis:

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

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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 (OS) 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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K222049

Device Name Yomi Robotic System

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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Image /page/3/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 a golden color. Above the word is a horizontal gray line, and to the right of the word is a gray crosshair symbol. The crosshair is positioned such that the horizontal line aligns with the top of the word, and the vertical line extends above and below the horizontal line.

510(k) Summary

K222049

l. Submitter

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

Contact Person:	Olga Lewis, Director of Regulatory Affairs
Date Prepared:	November 3, 2022

II. Device

Trade Name:	Yomi Robotic System
Common Name:	Dental Stereotaxic Instrument
Classification Name:	Bone cutting instrument and accessories (21 CFR)
Classification:	872.4120) Class II
Product Code:	QRY, PLV

III. Predicate Devices

Primary Predicate: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 K210711 Reference Device: Mako Partial Knee Application K142530

IV. Indications for Use

V. Device Description

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Image /page/4/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 a golden color. Above the word is a horizontal gray line that extends from the left of the "n" to the right of the "s". A vertical gray line intersects the horizontal line above the "o", forming a cross shape with a small circle at the intersection.

VI. Comparison of Technological Characteristics

The following Table 1 provides a summary of the subject Yomi System features compared to the predicate device, Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711), and a reference device, Mako Partial Knee Application (K142530). The MAKO device was chosen as the reference device since the visualization method during bone removal with the MAKO system for PKA is essentially the same as the subject device. Although the indications for use are different, the implementation of the visualization of the bone removal process is equivalent with both, the reference device as well as the predicate device.

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Image /page/5/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 a light orange color. Above the word is a gray line that extends horizontally, and a gray line that extends vertically, intersecting at a small circle.

Table 1: Comparison of technological characteristics to the predicates

TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem with Yomi RoboticGuided Bone Reduction	Primary Predicate: NeocisGuidance System (NGS) withYomi Plan v2.0.1 K210711	Reference Device: MakoPartial Knee ApplicationK142530	Comparison
IndicationsforUse (IFU)	Yomi Robotic System is acomputerized roboticnavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phasesof dental implantation surgery.The system provides software topreoperatively plan dentalimplantation procedures andprovides robotic navigationalguidance of the surgicalinstruments. The system can alsobe used for planning andperforming guided bonereduction (also known asalveoplasty) of the mandibleand/or maxilla. Yomi is intendedfor use in partially edentulous andfor fully edentulous adult patientswho qualify for dental implants.When YomiPlan software is usedfor preplanning on third party PCs,it is intended to perform theplanning (pre-operative) phase ofdental implantation surgery. YomiPlan provides pre-operativeplanning for dental implantationprocedures using the YomiRobotic System. The output ofYomi Plan is to be used with theYomi Robotic System.	Neocis Guidance System (NGS) isa computerized roboticnavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phasesof dental implantation surgery.The system provides software topreoperatively plan dentalimplantation procedures andprovides robotic navigationalguidance of the surgicalinstruments. The NGS is intendedfor use in partially edentulousand fully edentulous adultpatients who qualify for dentalimplants.When YomiPlan software is usedfor preplanning on third partyPCs, it is intended to perform theplanning (pre-operative) phase ofdental implantation surgery.YomiPlan provides pre-operativeplanning for dental implantationprocedures using the NGS. Theoutput of Yomi Plan is to be usedwith the NGS.	The Partial Knee Application (PKA),for use with the Robotic ArmInteractive Orthopedic System(RIO), is intended to assist thesurgeon in providing softwaredefined spatial boundaries fororientation and referenceinformation to anatomicalstructures during orthopedicprocedures.The Partial Knee Application(PKA), for use with the RoboticArm Interactive OrthopedicSystem (RIO), is indicated for usein surgical knee procedures inwhich the use of stereotacticsurgery may be appropriate, andwhere reference to rigidanatomical bony structures can beidentified relative to a CT basedmodel of the anatomy. Theseprocedures include unicondylarknee replacement and/orpatellofemoral knee replacement.The Implant systems with whichthe system is compatible:-Restoris MulticompartmentalKnee System-Restoris Porous Partial KneeSystem	When compared tothe primary predicatedevice, K210711,added text specific tobone reduction.Reference device hasdifferent indicationsbut overall isequivalent since itoffers power toolsand softwaremodifications forbone cutting.
TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem with Yomi RoboticGuided Bone Reduction	Primary Predicate: NeocisGuidance System (NGS) withYomi Plan v2.0.1 K210711	Reference Device:Partial Knee ApplicationK142530	Comparison
RoboticGuideArm	Guided robotic arm	Guided robotic arm	Guided robotic arm	Equivalent
MovementDirection	Guided Robotic Arm holds asurgical instrument andprovides haptic feedback onposition with respect to theplan restricting movementoutside of volume predefinedduring planning.6 degrees of freedom	Guided Robotic Arm holds asurgical instrument andprovides haptic feedback onposition with respect to theplan restricting movementoutside of volume predefinedduring planning.6 degrees of freedom	Guided Robotic Arm holds asurgical instrument andprovides haptic feedback onposition with respect to theplan restricting movementoutside of volume predefinedduring planning.6 degrees of freedom	Equivalent
Patientaffixedtracking parts	Splints with arrays	Splints with arrays	Femoral and tibial trackingarrays affixed to bones duringsurgery	Equivalent
Patient TrackingMechanism	Physical linkage to patient viaPatient Tracker (PT), KinematicMount (KM), and End Effector(EE) connected to splints	Physical linkage to patient viaPatient Tracker (PT),Kinematic Mount (KM), andEnd Effector (EE) connected tosplints	Optical IR camera used fortracking femoral and tibialarrays	Equivalent
Fiducials for CTscan	Fiducial Array (FA) attached tosplint	Fiducial Array (FA) attached tosplint	Fiducials	Equivalent
PoweredHandpiece	Handpiece and drills	Handpiece and drills	Anspach Black Max bonecutting system	Equivalent
Cutting tools	Burs and drills	Drills and burs	Burs	Equivalent
PlanningandGuidanceSoftware	Updated Yomi Plan and NeoKsoftware to support bonereduction feature (Windows-based)	Yomi Plan software used forplanning and osteotomy(Windows-based)	Linux-based softwareapplication used for planningand bone preparation	Equivalent
Workflow	Surgeon plans bone reductionand implant placement andexecutes according to the planfollowing steps displayed on	Surgeon plans implantplacement and executesaccording to the planfollowing steps displayed on	Surgeon plans surgicalprocedure, including bonecutting and implant placement,and executes according to the	Equivalent
TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem with Yomi RoboticGuided Bone Reduction	Primary Predicate: NeocisGuidance System (NGS) withYomi Plan v2.0.1 K210711	Reference Device: MakoPartial Knee ApplicationK142530	Comparison
	the GUI	the GUI	plan following steps displayedon the GUI
Visualization ofBone Removal	Bone to be removed is coloredand during removal, the colorof the bone on the screen isupdated (in real time) toanother color to reflect boneremoval.	N/A	Bone to be removed is coloredand during removal, the colorof the bone on the screen isupdated (in real time) toanother color to reflect boneremoval.	Equivalent
PerformanceTesting	Unit Level TestingIntegration and regressiontestingVerification testing of the newhandpiece and burVerification of bone reductionplanning, visualization, andperformanceBone reduction accuracyverificationFull system cadaver validation	Unit Level TestingIntegration and regressiontestingVerification testing ofcompatible instrumentationVerification of osteotomyplanning, visualization, andperformanceOsteotomy accuracyverificationFull system cadaver validation	Sub-system level softwarefunctional testing of Setup andBone PreparationImplant visuals, boundaries andstereotactic verificationResection accuracy verificationFull system mock procedurerun-through verificationFull system cadaver validation	Equivalent

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Image /page/6/Picture/0 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, and to the right of the word is a gray crosshair symbol with a circle in the center.

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Image /page/7/Picture/0 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in a golden color. Above the word is a gray horizontal line that extends beyond the word on both sides. There is a small circle above the "i" with a vertical line extending above it, creating a crosshair-like design.

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Image /page/8/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 a light orange color. A thin gray line runs above the word. To the right of the word, there is a gray symbol that looks like a plus sign with a small circle in the center.

VII. Performance Testing

Software verification testing has been fully executed to ensure that the software user interface functions as intended according to the following:

ANSI AAMI ISO 14971: 2019 Medical devices - Applications of risk management to medical devices
. ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions ● for Software Contained in Medical Devices Document issued on: May 11, 2005
Guidance for Industry and FDA Staff General Principles of Software Validation Document ● issued on: January 11, 2002

Additionally, verification testing for new instruments used in bone reduction procedures has been performed with the Yomi System along with validation testing, including cadaveric Human Factors Validation for Bone Reduction and Software End User Validation of Bone Reduction.

VIII. Conclusion

This submission introduces a bone reduction feature to the Yomi Robotic System. There are no changes to the intended use compared to the predicate device. There are no fundamental changes to the technology. The performance testing demonstrates substantially equivalent performance of the subject device as compared 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.