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 and fully 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. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

Device Description

Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. 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 Robotic System allows the user to plan the surgery virtually in YomiPlan, 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 FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Clamped Chairside Patient Splint (C-CPS) or YomiLink Bone (YLB), the Tracker End Effector (TEE) 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 to modify the design and reprocessing method for the Tracker End Effector (TEE) of the Yomi Robotic System. All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
System Accuracy	Total System Accuracy Verification	Performed (demonstrates substantially equivalent performance)
Kinematic Performance	Kinematic Mount Repeatability Verification	Performed (demonstrates substantially equivalent performance)
Drill Jig Accuracy	Drill Jig Accuracy Verification	Performed (demonstrates substantially equivalent performance)
Reprocessing Effectiveness	High-Level Disinfection Validation (per AAMI TIR12 and FDA Guidance)	Performed (demonstrates disinfection provides adequate microbicidal reprocessing)
Reprocessing User Experience	Usability validation testing for modified reprocessing instructions	Performed (included dental clinician users evaluating critical tasks and providing feedback)
Material Properties	Verification testing for modified material (Aluminum 7075 vs 6061)	Performed (demonstrates no impact on substantial equivalence)
Mating Component Design	Verification testing for V-coupled design vs. fiducial pins/spheres	Performed (demonstrates no impact on substantial equivalence)

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

The document does not explicitly state the sample sizes used for the performance tests (Total System Accuracy, Kinematic Repeatability, Drill Jig Accuracy, Disinfection Validation, Material Testing, Mating Component Design Verification). It only indicates that these tests were "fully executed."

For the Usability Validation Testing for reprocessing instructions, the document mentions "dental clinician users," but the specific number (sample size) is not provided. The data provenance is implied to be through direct observation and feedback from these users.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the performance tests. These tests appear to be engineering verification and validation tests rather than clinical studies requiring expert ground truth in the traditional sense.

For the Usability Validation Testing, it states that "dental clinician users" were involved, but their specific qualifications (e.g., years of experience, specialty) or the number of such users are not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for any of the described tests. The tests appear to be objective verification and validation tests where outcomes are measured against predefined technical specifications or industry standards.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on performance testing related to design modifications and reprocessing.

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

The Yomi Robotic System is described as 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." This implies a human-in-the-loop system. The document does not describe any standalone performance studies where the algorithm or robotic system operates without human interaction or oversight for clinical decision-making or execution. The "Total System Accuracy Verification" would likely assess the machine's standalone accuracy within the system's design, but not as a replacement for human performance.

7. Type of Ground Truth Used

For the performance tests (accuracy, repeatability, drill jig accuracy, material, design), the ground truth would be based on engineering specifications, metrology standards, and validated test methods. For the disinfection validation, the ground truth is established by microbiological testing against industry standards (AAMI TIR12 and FDA Guidance). For the usability testing, the ground truth is likely based on user feedback and successful completion of critical tasks as defined by the usability protocol. No explicit mention of clinical outcomes data or pathology as ground truth is made, which aligns with the focus on design modifications and reprocessing rather than a new clinical application.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is a robotic system providing navigational guidance. If any internal models or algorithms are used, the training data for those are not disclosed in this summary.

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

Since no training set is mentioned (or implied for AI/ML purposes), this information is not provided.

Summary

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Neocis Inc. Joshua Davis Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K222750

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: September 29, 2022 Received: September 30, 2022

Dear Joshua Davis:

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 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.

Andrew I. Steen -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K222750

Device Name Yomi Robotic System

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)

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510(k) Summary K22750

I. Submitter

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

Contact Person: Joshua Davis, Regulatory Affairs Manager Date Prepared: December 7, 2022

II. Device

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

III. Predicate Devices

Primary Predicate: Yomi Robotic System (K222049) Reference Device: Neocis Guidance System (K191605) Reference Device: Neocis Guidance System (K161399) Reference Device: Resert XL HD High-Level Disinfectant (K091022)

IV. Indications for Use

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. YomiPlan provides pre- operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

V. Device Description

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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.

VI. Comparison of Technological Characteristics

The following Table 1 provides a summary of the subject Yomi Robotic System features compared to the predicate device, Yomi Robotic System (K222049).

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TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem	Primary Predicate: YomiRobotic System (K222049)	Comparison
Indications forUse (IFU)	Yomi Robotic System is acomputerized robotic navigationalsystem intended to provideassistance in both the planning(pre-operative) and the surgical(intra-operative) phases of dentalimplantation surgery. The systemprovides software to preoperativelyplan dental implantationprocedures and provides roboticnavigational guidance of thesurgical instruments. The systemcan also be used for planning andperforming guided bone reduction(also known as alveoplasty) of themandible and/or maxilla. Yomi isintended for use in partiallyedentulous and fully edentulousadult patients who qualify fordental 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 Yomi RoboticSystem. The output of YomiPlan isto be used with the Yomi RoboticSystem.	Yomi Robotic System is acomputerized roboticnavigational system intendedto provide assistance in boththe planning (pre-operative)and the surgical (intra-operative) phases of dentalimplantation surgery. Thesystem provides software topreoperatively plan dentalimplantation procedures andprovides robotic navigationalguidance of the surgicalinstruments. The system canalso be used for planning andperforming guided bonereduction (also known asalveoplasty) of the mandibleand/or maxilla. Yomi isintended for use in partiallyedentulous and fullyedentulous adult patients whoqualify for dental implants.When YomiPlan software isused for preplanning on thirdparty PCs, it is intended toperform the planning (pre-operative) phase of dentalimplantation surgery. YomiPlan provides pre-operativeplanning for dentalimplantation procedures usingthe Yomi Robotic System.The output of Yomi Plan is tobe used with the YomiRobotic System.	Equivalent
Principles ofOperation	The Tracker End Effectorphysically attaches to, and provideslinkage between, the PatientTracker of the Yomi RoboticSystem and the Patient Splint. TheTracker End Effector is connectedto the Patient Tracker via a screw atthe Patient Tracker Flange. The	The Tracker End Effectorphysically attaches to, andprovides linkage between, thePatient Tracker of the YomiRobotic System and the PatientSplint. The Tracker EndEffector is connected to thePatient Tracker via a screw at	Equivalent
TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem	Primary Predicate: YomiRobotic System (K222049)	Comparison
	Tracker End Effector is then alsoconnected via screw to the PatientSplint.	the Patient TrackerFlange. The Tracker EndEffector is then also connectedvia screw to the Patient Splint.
Robotic GuideArm	Guided robotic arm	Guided robotic arm	Equivalent
MovementDirection	Guided Robotic Arm holds a surgicalinstrument and provides hapticfeedback on position with respect tothe plan restricting movement outsideof volume predefined duringplanning.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
Patient affixedtracking parts	Splints with arrays	Splints with arrays	Equivalent
Patient TrackingMechanism	Physical linkage to patient via PatientTracker (PT), Kinematic Mount(KM), and Tracker End Effector(TEE) connected to splints	Physical linkage to patient viaPatient Tracker (PT),Kinematic Mount (KM), andTracker End Effector (TEE)connected to splints	Equivalent
Fiducials for CTscan	Fiducial Array (FA) attached to splint	Fiducial Array (FA) attachedto splint	Equivalent
Patient Contact	No contact	No contact	Equivalent
ReprocessingClassification	Non-critical	Non-critical	Equivalent
ReprocessingMethod forTracker EndEffector	High level disinfection	Sterilization	EquivalentDisinfectionvalidation testinghas demonstrateddisinfection of thesubject deviceprovides adequatemicrobicidalreprocessing
MatingComponentDesign	V-coupled design	Fiducial pins and spheres	EquivalentVerification testinghas demonstrated themodified design hasno impact on
TechnologicalCharacteristics	Subject Device: Yomi RoboticSystem	Primary Predicate: YomiRobotic System (K222049)	Comparison
			substantialequivalenceEquivalent
Materials	TEE main body: Aluminum 7075TEE thumb screws: Stainless Steel316	TEE main body: Aluminum6061TEE thumb screws: StainlessSteel 316	Verificationtesting hasdemonstrated themodified materialhas noimpact on substantialequivalence
PerformanceTesting	Total System AccuracyKinematic MountRepeatabilityDrill Jig AccuracyDisinfection ValidationReprocessing InstructionValidation	Total System AccuracyKinematic MountRepeatabilityDrill Jig Accuracy	Equivalent

Table 1: Comparison of technological characteristics to the predicate

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VII. Performance Testing

The following testing has been fully executed to ensure that the subject device functions as intended:

Total System Accuracy Verification
Kinematic Repeatability Verification
Drill Jig Accuracy Verification ●
High-Level Disinfection Validation was performed in accordance with recommended evaluations as listed in AAMI TIR12 and Guidance for Industry and FDA Staff -Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

Usability validation testing for the modified reprocessing instructions has been performed. Usability testing included dental clinician users who were evaluated on critical tasks for the disinfection steps per the disinfection instructions for use and provided responses to open-ended questions.

VIII. Conclusion

This subject of this submission is to modify the design and reprocessing method for the Tracker End Effector (TEE) of 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.