OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

Device Description

OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments.

AI/ML Overview

The provided text is a K213263 510(k) summary for the OnyxCeph3™ device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that "Clinical testing has not been included and is not required to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information from the given text.

Summary

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January 4, 2023

Image Instruments GmbH % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606

Re: K213263

Trade/Device Name: OnyxCeph3TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, PNN Dated: November 30, 2022 Received: December 5, 2022

Dear Greg Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

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) K213263

Device Name OnyxCeph3TM

Indications for Use (Describe)

OnyxCeph*™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph7™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

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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5. 510(k) Summary - K213263

510(k) Owner	Image Instruments GmbHNiederwaldstr. 309123 ChemnitzGermanyPhone: +49 371 9093140Facsimile: +49 371 9093149		OnyxCeph3 TMK213263Subject Device	VISTADENTTM ATCOMPLETE K053010Predicate Device		OnyxCeph3™K213263Subject Device	VISTADENT™ ATCOMPLETE K053010Predicate Device
Contact person	Greg HollandRegulatory Specialists, Inc.3722 Ave. SausalitoIrvine, CA 92606Phone: 949.262.0411Fax: 949.552.2821Email: greg@regulatoryspecialists.com	Intended Use	Orthodontic Software	Orthodontic Software	Indications forUse	OnyxCeph3™ softwareis intended to be usedfor the medicalpurpose of managingand evaluating two-dimensional and three-dimensional images inthe framework ofdigital orthodontics byqualified staff only.The use ofOnyxCeph3™ requiresthe user to have thenecessary training anddomain knowledge inthe practice oforthodontics, as wellas to have received adedicated training inthe use of thesoftware.The software can beused to digitally performcertain image- basedorthodontic workflows,such as metric andangular evaluation ofimage data.	VISTADENT™ ATCOMPLETE software isa digital database forstoring, retrieving andprinting images that alsohas the ability to performimage manipulation andcephalometric analysis.
Submission Date	January 3, 2023	Product Code	LLZ	LLZ
Common NameTrade NameClassification NameRegulationClassPanelPrimary Product CodeSecondary Product Code	Orthodontic SoftwareOnyxCeph3TMRadiological Image Processing System892.2050Class IIDentalLLZPNN	2 DimensionalImage Import	Yes	Yes
Primary Predicate Device	K053010VISTADENTTM ATCOMPLETEFrom: Dentsply INTL.,Inc.	2 DimensionalImage Adjust	Yes	Yes
Reference Device	K171634Ortho SystemTMFrom: 3Shape A/SK192475NemoFABFrom: SoftwareNemotec S.L.

Description

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Intended Use

OnyxCeph3™ is a software only device and is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and threedimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software. Diagnostic and therapeutic decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.

Indications for Use

OnyxCeph3™ software is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

Technological Characteristics

The predicates and the Image Instruments GmbH OnyxCeph3™ were compared in the following areas and found to have similar technological characteristics and to be equivalent. Both predicates are shown as a comparison in separate tables.

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	OnyxCeph3™K213263Subject Device	VISTADENT™ ATCOMPLETE K053010Predicate Device
2 DimensionalCephalometricEvaluation	Yes	Yes
2 DimensionalImageCombination	Yes	Yes
2 DimensionalImageComparison	Yes	Yes
2 DimensionalMirroring	Yes	Yes
CO/CR-Conversion	Yes	Yes
Ricketts VTO	Yes	Yes
2 DimensionalTreatmentSimulation	Yes	Yes
Windows Based	Yes	Yes
Activation byKey	Yes	Yes
ClientRequirements	Hardware Type, CPU,RAM, Disk, Network,Graphic Board, DesktopResolution	Hardware Type CPU, RAM,Disk, Network, GraphicBoard,Desktop Resolution
ClientRequirements	Not Required	Internet Access,Internet Speed
ServerRequirements	Hardware Type, CPU,RAM, Disk, Network,Port Sharing	Hardware Type, CPU,RAM, Disk, Network,Port Sharing

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	OnyxCeph3™K213263Subject Device	Ortho System3Shape A/SK171634ReferenceDevice
Intended UseIndications	Orthodontic SoftwareOnyxCeph3™ software isintended to be used for themedical purpose ofmanaging and evaluatingtwo-dimensional andthree-dimensional imagesin the framework of digitalorthodontics by qualifiedstaff only. The use ofOnyxCeph3™ requires theuser to have the necessarytraining and domainknowledge in the practiceof orthodontics, as well asto have received adedicated training in theuse of the software.The software can be usedto digitally perform certainimage- based orthodonticworkflows, such as metricand angular evaluation ofimage data.	Orthodontic SoftwareThe 3Shape OrthoSystem™ is intended foruse as a medical front-end device providingtools for management oforthodontic models,systematic inspection,detailed analysis,treatment simulation andvirtual appliance designoptions (Custom MetalBands, Export ofModels, IndirectBonding TransferMedia) based on 3Dmodels of the patient'sdentition before the startof an orthodontictreatment. It can also beapplied during thetreatment to inspect andanalyze the progress ofthe treatment. It can beused at the end of thetreatment to evaluate ifthe outcome isconsistent with theplanned/desiredtreatment objectives.The use of the OrthoSystem™ requires theuser to have thenecessary training anddomain knowledge inthe practice oforthodontics, as well asto have received adedicated training in theuse of the software.
Product Code	LLZ	PNN
	OnyxCeph3TMK213263Subject Device	Ortho System3Shape A/SK171634ReferenceDevice
2 DimensionalEvaluation	Yes	Yes
2 DimensionalCephalometricEvaluation	Yes	No
3 DimensionalEvaluation	Yes	Yes
Supportedanatomical areas	Maxilla and Mandible	Maxilla and Mandible
Determine archshape	Yes	Yes
Determine wirelength	Yes	Yes
Determine toothwidth	Yes	Yes
Determine Bolton	Yes	Yes
Determine spaceanalysis	Yes	Yes
Determine overbite	Yes	Yes
Determineocclusion	Yes	Yes
Extract/SegmentVolume Scans	Yes	Yes
Combine Bony andDental Scan Data	Yes	Yes
Windows Based	Yes	Yes
Data Storage	Local	Local / Cloud
Activation byDongle	No	Yes
	OnyxCeph3™K213263Subject Device	Ortho System3Shape A/SK171634ReferenceDevice
Activation by Key	Yes	No
ClientRequirements	Hardware Type, CPU,RAM, Disk, Network,Graphic Board, DesktopResolution	Hardware Type, CPU,RAM, Disk, Network,Graphic Board,Desktop Resolution
ClientRequirements	Not required	Internet Access,Internet Speed
ServerRequirements	Hardware Type, CPU,RAM, Disk, Network,Port Sharing	Hardware Type, CPU,RAM, Disk, Network,Port Sharing

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Although the Indications for Use Statement for the subject device is different from the predicate device, K053010, the intended use of the software is the same, to allow for two-dimensional and three-dimensional evaluation of images. The predicate device includes Internet Access which is not required for the subject device. The subject device includes 3-dimensional evaluation capabilities; whereas the predicate device does not. However, the reference devices support this function.

The reference device, K171634, was included to support the 3-dimensional evaluation capabilities of the subject device. This reference device does not include 2-Dimensional Cephalometric function, and activation by Key. However, the 2-Dimensional Cephalometric function is supported by the predicate device. The reference device offers activation by Dongle. In addition, the reference device supports the use of Data Storage via the Cloud and requires Internet Access whereas the subject device does not.

Additional reference device, K192475 was included to support the devices intended use for supporting the treatment planning process of orthognathic procedures.

In summary, the similarities between the subject device, OnyxCeph3™, and the predicate devices are functionally very similar. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above.

Nonclinical Testing

Software Validation conducted per FDA Guidance for Software Contained in Medical Devices IEC 62304 - Software Life Cycle Processes

Clinical Testing

Clinical testing has not been included and is not required to demonstrate substantial equivalence.

Conclusion

Based on the similarities between the intended use, indications, principle of operation, features and technical data, the subject device, OnyxCeph3™, is found to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).