Planmeca Romexis is a medical imaging software intental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the plant position a model of a surgical guide for a guided implant surgery can be designed objects can be exported to manufacture a separate physical product.

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in standard PC.

The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

Device Description

Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units.

Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis, but original exposure is always kept in the database for reference.

lmages can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.

AI/ML Overview

The provided text describes Planmeca Romexis, a medical imaging software. However, it does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot directly answer your request based on the provided text. The document lists the following:

Indications for Use: The software's intended uses (displaying 2D/3D images, dental implant planning, surgical treatment simulation, jaw movement monitoring, device maintenance).
Technological Characteristics Comparison: A table comparing features of Planmeca Romexis with predicate and reference devices, highlighting similarities in operating environment, functionalities, image files, and major features.
Non-Clinical Test Results: A general statement about quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Performance testing, Safety testing, Final acceptance testing, Bench testing). It concludes that testing confirmed stability, operation as designed, hazard evaluation, and risk reduction. It also states that bench testing compared images rendered by Planmeca Romexis with predicate software and confirmed they are "equally effective in performing the essential functions and provide substantially equivalent clinical data."

Missing Information:

The document does not provide:

A table of specific acceptance criteria and reported device performance against those criteria.
Sample sizes for a test set, data provenance, or details about retrospective/prospective nature of a study.
Number or qualifications of experts for ground truth establishment.
Adjudication method for a test set.
MRMC comparative effectiveness study details, including effect size.
Details about a standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

In summary, while the document confirms non-clinical testing was performed to establish substantial equivalence, it does not detail the specific acceptance criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) that would prove the device quantitatively meets such criteria.

Summary

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December 2, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Planmeca Oy % Lars Moring Regulatory Affairs Manager Asentajankatu 6 Helsinki. 00880 FINLAND

Re: K200572

Trade/Device Name: Planmeca Romexis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 19, 2020 Received: October 23, 2020

Dear Lars Moring:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K200572

Device Name Planmeca Romexis

Indications for Use (Describe)

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

Indications of the dental implants do not change with guided surgery compared to conventional surgery.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

K200572

DATE

October 19, 2020

PRODUCT, CLASSIFICATION NAME

Device name:	Planmeca Romexis
Common name:	System, Image Processing, Radiological
Classification:	Class II
Classification name:	Imaging Processing System, LLZ, 21 CFR 892.205

SUBMITTED BY

Planmeca Oy Asentajankatu 6 00880 Helsinki, Finland Phone: +358 20 7795 500 Contact person: Mr. Lars Moring

U.S DESIGNATED AGENT

Planmeca USA Inc. 2600 Forbs Ave., Hoffman Estates, IL 60192 Phone: (630) 529 2300 Contact person: Ed McDonough

DEVICE DESCRIPTION

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INDICATIONS FOR USE

Planmeca Romexis is a medical imaging software intented for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients.

Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed. The designed objects can be exported to manufacture a separate physical product.

Planmeca Romexis is also a preoperative software for simulating surgical treatment options.

Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla.

The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the necessary medical training in maxillofacial surgery.

Indications of the dental implants do not change with quided surgery compared to conventional surgery.

EQUIVALENT DEVICES

	Primary predicate device:
K123519	Anatomage	InVivoDental

Reference devices:

Televere Systems K061035 K141570 3Shape Medical K133320 SICAT

TigerView Implant Studio SICAT Function

Newly added reference device:
K110430	Patterson Dental

Dolphin Imaging

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INDICATIONS FOR USE COMPARISON

The indications for use of Planmeca Romexis is substantially equivalent to that of the predicate devices, with few exceptions that do not raise any new or potential safety risks to the user or patient. The most evident is that Planmeca Romexis includes service managing features for Planmeca devices for maintenance purposes, which are not intended for clinical use.

TECHNOLOGICAL CHARACTERISTICS

A comparison of key software characteristics, including operating environment, functionalities, image files, and other major features was performed. Some general comparison data:

Primary predicate device:

	Planmeca Romexis	InVivoDental (K123519)
Operating environment	standard PC hardware	standard PC hardware
Functionalities	Viewing, enhancing,processing, archiving, printingand sharing images	Retrieve, process, render,review, store, print, assist indiagnosis, and distributeimages
Image files	2D, 3D	3D
Major features	Multiplanar views	Section and Multislice ViewOperations
	3D volume rendering view	Volume Rendering of scandata
	Linear, angular, area andvolumetric measurements	Linear, Angular,Circumferential, Area andVolumetric Measurements
	Implant Planning module	Implant, Abutment andRestoration TreatmentPlanning
	Airway volume measurement	Quick Airway VolumeMeasurement and Evaluation
	TMJ module	TMJ Applications
	Virtual Cephalometric image	SuperCeph
	Virtual Panoramic image	SuperPano
	Software Viewer	InVivo Viewer

Reference devices:

	Planmeca Romexis	TigerView Professional(K061035)
Operating environment	standard PC hardware	standard PC hardware
Functionalities	Viewing, enhancing,processing, archiving, printingand sharing images	acquire, display, edit, review,store, print, and distributeimages
Image files	2D, 3D	2D

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Integration with PracticeManagement Systems	YES	YES
Integration with hospital PACSsystems	YES	YES
Features	image processing, brightness &contrast, crop, annotations	resize, adjust contrast, crop,annotate

	Planmeca Romexis	Implant Studio(K141570)
Operating environment	standard PC hardware	standard PC hardware
Functionalities	Viewing, 3D data fitting, implantplanning, implant guidedesigning	prosthetic driven implantplanning, surgical guidedesign
Image files	2D, 3D	3D
Major features	Implant guide designing,implant and sleeve libraries	Implant guide designing,implant and sleeve libraries

	Planmeca Romexis	SICAT Function(K133320)
Operating environment	standard PC hardware	standard PC hardware
Functionalities	Viewing, enhancing,processing, archiving, printingand sharing images	Visualization andsegmentation ofimaging information
Visualized data types	2D, 3D, optical impressions,jaw motion data	3D volume data, opticalimpressions, jaw motion data
Major features	Visualization of 3D imagesusing multi-planar 2D views, 3Dvolume rendering, 3D surfacerendering	Visualization of 3D imagesusing 2D slice views, 3Dvolume rendering, 3D surfacerendering
	Fitting of optical impressions to3D image	Registration of optical scans tovolume data
	Segmentation of the jaws	Segmentation of jaws usingwizard
	Visualization of jaw movementdata	Visualization of jaw movementdata

Comparison table between the subject and newly added reference device:

	Planmeca Romexis	Dolphin Imaging(K110430)
Operating environment	Standard PC hardware	Windows OS
Visualized data types	2D, 3D, optical impressions, 3Dface photos	2D, digital study models, 3D,3D face camera photos
Major features	Visualization of 3D imagesusing multi-planar 2D views, 3Dvolume rendering, 3D surfacerendering, airway rendering	Multi-planar visualization,rendering of 3D volume, 3Dphoto, digital impression,airway
	Linear, angular, area and	3D-2D measurements:
	volumetric measurements	distance, angle, area
	Segmentation of jaws	Segmentation of image data

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Definition of osteotomy planes	Definition of osteotomy planes
Free movement and rotation ofbone fragments.	Treatment simulation bymoving skeletal structures

Based on the presented technical comparison of the Planmeca Romexis and the predicate devices it was concluded that these devices are technically substantially equivalent.

The differences found are not significant as they do not raise any new or potential safety risks to the user or patient, or questions related to safety or effectiveness.

NON-CLINICAL TEST RESULTS

The following quality assurance measures were applied to the development of the Software:

Risk Analysis
Requirements Reviews
Design Reviews
. Performance testing (Verification)
. Safety testing (Verification)
. Final acceptance testing (Validation)
Bench testing to compare with predicate software ●

Testing confirmed that Planmeca Romexis is stable and operating as designed. Testing also confirmed that Planmeca Romexis has been evaluated for hazards and that the risk has been reduced to acceptable levels.

The non-clinical bench-testing of Planmeca Romexis with predicate software versions were performed by comparison of images rendered by Planmeca Romexis and the predicate software versions. The results confirm that the software applications are equally effective in performing the essential functions and provide substantially equivalent clinical data.

SUMMARY

Based on the intended use, product, performance, and testing information provided in this notification, the subject device has been shown to be substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate devices.

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).