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 robotional 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 Robotic System 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. 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 the 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 Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).

Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

AI/ML Overview

This document describes the regulatory approval of the Neocis Yomi Robotic System with new accessories (YomiLink Arch and Probing Bit), indicating substantial equivalence to a previously cleared device. However, it does not provide explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for an AI device. Instead, it refers to performance testing conducted to ensure the device functions as intended.

Based on the provided text, here's an attempt to structure the information, acknowledging the limitations for a full AI acceptance criteria description:

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary for a robotic surgical system, not a purely AI diagnostic or prognostic device, the "acceptance criteria" are described in terms of verification and validation testing to ensure the added accessories and workflow maintain the system's intended function and safety. Specific numerical performance metrics for AI algorithms (like sensitivity or specificity) are not provided in this regulatory summary.

Acceptance Criteria Category (as inferred from Performance Testing)	Reported Device Performance (as inferred from "Verification/Validation" statements)
Total System Accuracy Verification (with YLA workflow)	"fully executed to ensure that the subject device functions as intended"
Guided Splint Placement Verification (as part of YLA workflow)	"fully executed to ensure that the subject device functions as intended"
Probing and Registration Verification (of YLA)	"fully executed to ensure that the subject device functions as intended"
Deflection and Repeatability Verification (of YLA attachment)	"fully executed to ensure that the subject device functions as intended"
Proximity Warnings Verification (generated throughout YLA workflow)	"fully executed to ensure that the subject device functions as intended"
Typical Run Through Verification (of user application throughout YLA workflow)	"fully executed to ensure that the subject device functions as intended"
Human Factors Validation (of YLA design)	"fully executed to ensure that the subject device functions as intended"
Software End User Validation (YLA user application meets user requirements)	"fully executed to ensure that the subject device functions as intended"
Biocompatibility	Met per FDA Guidance Document for Use of Standard ISO 10993-1
Validated Cleaning & Sterilization Instructions	Met per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1 and ISO 17665-2

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

The document does not specify the sample size for individual tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be a series of engineering and usability validations rather than a clinical study with a patient-derived test set in the conventional sense of AI performance evaluation. The "test sets" would likely refer to engineering models, simulated environments, and potentially cadaveric or phantom models for accuracy and repeatability testing.

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

This information is not provided in the document. For a robotic system, "ground truth" often involves highly precise measurement equipment and established engineering benchmarks rather than expert clinical consensus for image interpretation. For human factors validation, usability experts and clinicians would be involved, but specific numbers and qualifications are not listed here.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study is mentioned. This type of study is typically performed for AI systems that assist human readers in diagnostic or screening tasks. The Yomi Robotic System is a surgical guidance system, and the "AI" component is more embedded in its navigation and planning software, not as a separate diagnostic reader.

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

The performance testing revolves around the integrated system, including the software and new accessories (YomiLink Arch and Probing Bit) as they interact within the existing Yomi Robotic System workflow. While core algorithm accuracy is verified, it's presented within the context of the overall system's function, not as a standalone AI diagnostic output. The YomiPlan software is for preplanning, and its output is to be used with the Yomi Robotic System, not as a standalone diagnostic.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy and performance would be established through a combination of methods typical for robotic systems:

Physical measurements: Using highly accurate metrology equipment to verify positioning, deflection, and repeatability against known physical standards.
Engineering specifications: Comparing system performance against pre-defined engineering tolerances and design requirements.
Simulation/Phantoms: Testing the system's ability to accurately navigate and execute plans on controlled phantom models.
User requirements: For human factors and software end-user validation, the "ground truth" would be the successful completion of tasks by users in accordance with specified requirements and industry standards for usability.

Specific details about the type of ground truth for each test are not elaborated in this summary.

8. The Sample Size for the Training Set

The document does not mention the sample size for the training set. For a robotic navigational system like Yomi, "training" might refer to the development and refinement of algorithms for spatial recognition, registration, and robotic control. This process typically involves extensive internal validation and iterative development with various datasets (e.g., 3D models, CBCT scans) but does not necessarily align with the concept of a "training set" in the context of supervised machine learning for diagnostic tasks.

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

This information is not provided. Similar to point 7, the "ground truth" for developing such a system would be based on engineering principles, known anatomical landmarks, and precise spatial measurements to ensure accurate digital representations and their correlation with physical reality for robotic guidance.

Summary

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

Re: K231018

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: PLV, QRY Dated: July 13, 2023 Received: July 14, 2023

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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Indications for Use

510(k) Number (if known) K231018

Device Name Yomi Robotic System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 K231018

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: August 14, 2023

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 QRY, PLV Product Code:

III. Predicate and Reference Devices

Primary Predicate: Yomi Robotic System (K222750) Reference Device: Yomi Robotic System (K211129)

IV. Indications for Use

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 Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

V. Device Description

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for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

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 (K222750), and reference device, Yomi Robotic System (K211129).

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Table 1: Comparison of technological characteristics to the predicate and reference devices.

TechnologicalCharacteristics	Subject Device: YomiRobotic System withYomiLink Arch	Primary Predicate: YomiRobotic System withIntraoral Fiducial Array(K222750) & ReferenceDevice: Yomi RoboticSystem (K211129)	Comparison
Indications forUse (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 softwareto preoperatively 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 RoboticSystem is intended for use inpartially edentulous 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. YomiPlanprovides pre-operative planningfor dental implantationprocedures using the YomiRobotic System. The output ofYomiPlan is to be used with theYomi Robotic System.	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. YomiPlanprovides pre-operativeplanning for dentalimplantation procedures usingthe Yomi Robotic System. Theoutput of YomiPlan is to beused with the Yomi RoboticSystem.	Equivalent
TechnologicalCharacteristics	Subject Device: YomiRobotic System withYomiLink Arch	Primary Predicate: YomiRobotic System withIntraoral Fiducial Array(K22750) & ReferenceDevice: Yomi RoboticSystem (K211129)	Comparison
Principles ofOperation	YomiLink Arch containsfiducial markers that allow forregistration in CBCT scansprior to surgery. The TrackerEnd Effector is attached toYomiLink Arch to provide aconnection between the patientand the Patient Tracker arm ofthe system. YomiLink Archcontains divots that can then beprobed with the robot to matchto known locations in the CBCTscan image space based on thefiducial markers	The Intraoral Fiducial Arraycontains fiducial markers thatallow for registration in CBCTscans prior to surgery. TheIntraoral Fiducial Arraymounts to the YomiLink Teethpatient splint	Equivalent
Robotic GuideArm	Guided robotic arm	Guided robotic arm	Equivalent
MovementDirection	Guided Robotic Arm holds asurgical instrument andprovides haptic feedback onposition with respect to the planrestricting movement outside ofvolume 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	YomiLink ArchSplints	Splints with arrays	Equivalent
Patient TrackingMechanism	Physical linkage to patient viaPatient Tracker (PT), KinematicMount (KM), and Tracker EndEffector (TEE)	Physical linkage to patient viaPatient Tracker (PT),Kinematic Mount (KM), andTracker End Effector (TEE)	Equivalent
Fiducials for CTscan	YomiLink Arch containsfiducial beads and is placeddirectly on patient arch duringthe CT scan to provide areference in the image	Intraoral Fiducial Arraycontains fiducial beads and isattached to patient splintduring the CT scan to providea reference in the image	Equivalent
TechnologicalCharacteristics	Subject Device: YomiRobotic System withYomiLink Arch	Primary Predicate: YomiRobotic System withIntraoral Fiducial Array(K222750) & ReferenceDevice: Yomi RoboticSystem (K211129)	Comparison
Probing Bit	YLB is registered by probingthe YLA divots	N/A. YLB is registered viaCT scan	Equivalent
Patient Contact	Surface deviceLimited duration	Surface deviceLimited duration	Equivalent
Biocompatibility	Mucosal membrane, tissue, bone,dentin contact	Mucosal membrane, tissue,bone, dentin contact	Equivalent
ReprocessingClassification	N/A. Single use only	Non-critical reusable	Equivalent
ReprocessingMethod	N/A. Single use only.Sterilized by the end user prior touse	Cleaning & Sterilization	Equivalent
SterilizationMethod	Provided unsterile, end usermoist heat sterilized	Provided unsterile, end usermoist heat sterilized	Equivalent
MatingComponentDesign	Kinematic Mount	Kinematic Mount	Equivalent
Materials	Main body: Avaspire AV-651CF30Fiducial Beads: Silicon NitrideEpoxy: EA M-31CL epoxyProbing Bit: 17-4 Stainless Steel,Precipitation Hardened (PH)	Main body: Avaspire AV-651CF30Fiducial Beads: Silicon NitrideEpoxy: EA M-31CL epoxy	Equivalent
PerformanceTesting	Total System Accuracy• VerificationProbing and Registration• VerificationDeflection and• Repeatability VerificationGuided Splint Placement• VerificationProximity Warnings• VerificationTypical Run Through• VerificationHuman Factors• ValidationSoftware End User• Validation	Total System Accuracy• VerificationRegistration Verification• Deflection and• Repeatability VerificationHuman Factors• Validation	Equivalent

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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: to verify the accuracy of the full system with the additional YLA workflow
Guided Splint Placement Verification: to verify the accuracy of guided splint placement as part of the YLA workflow
Probing and Registration Verification: to verify the accuracy of probing the YLA ●
Deflection and Repeatability Verification: to assess the stability and repeatability of attachment of the YLA
Proximity Warnings Verification: to assess the proximity warnings generated in the user application throughout the YLA workflow
Typical Run Through Verification: to assess the typical steps in the user application ● throughout the YLA workflow
Human Factors Validation: to validate the human factors and design of the YLA ●
Software End User Validation: to validate that the YLA user application meets the user ● requirements

Non-clinical data referenced or relied upon for the subject YomiLink Arch and Probing Bit from the predicate, K222750, to demonstrate substantial equivalence include: Biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and validated cleaning & sterilization instructions per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17665-1 and ISO 17665-2.

VIII. Conclusion

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. which allow for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch. 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.