Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Device Description

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

AI/ML Overview

The information provided does not contain a discrete table of acceptance criteria or reported device performance metrics in the format requested. However, it does outline a clinical suitability assessment that served as the performance testing for the device. Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. Instead, it states that the device's clinical effectiveness was assessed by comparing its image rendering to that of predicate devices. The acceptance was qualitative: "image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." The implied acceptance criterion was that the image rendering of the Acteon Imaging Suite should be comparable and clinically suitable to the predicate devices. The reported device performance is that this comparison led to the conclusion of "substantial equivalence" based on "bench tests that compare clinical suitability of the rendering performed by Acteon Imaging Suite with the predicates."

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

The document mentions "the same images" were evaluated, but it does not specify the sample size (number of images or cases) used for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned.

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

Number of Experts: Three independent reviewers.
Qualifications: "having different backgrounds (maxillofacial surgery, orthodontics, dentistry)." No specific years of experience are provided.

4. Adjudication Method

The adjudication method appears to be consensus-based among the three independent reviewers judging "the image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use." No specific 2+1 or 3+1 method is described, but the phrase "Three independent reviewers... evaluated" implies a collective assessment rather than individual decisions.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as such. The study described was a qualitative comparison of image rendering for clinical suitability, where human readers (the three experts) compared the proposed device's output against predicate devices. The document does not report an effect size of how much human readers improve with AI vs without AI assistance because the device is an imaging suite, not an AI-powered diagnostic tool, and the study focused on image quality comparison, not diagnostic accuracy improvement.

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

The device, "Acteon Imaging Suite," is an application software suite for general dental and maxillofacial diagnostic imaging, controlling image retrieval, display, enhancement, and saving. It is not an AI algorithm with standalone diagnostic capabilities. Therefore, a standalone performance study in the context of an "algorithm only without human-in-the-loop performance" was not conducted as the device's function is to facilitate human interpretation and management of images. The performance testing described relates to the quality of the image rendering by the software, which is then interpreted by humans.

7. Type of Ground Truth Used

The "ground truth" for the test set was effectively expert consensus regarding the clinical suitability of the rendered images. It was not pathology, outcomes data, or another objective measure, but rather the subjective expert evaluation of image quality for diagnostic purposes.

8. Sample Size for the Training Set

The document does not mention a training set sample size. The evaluation described is a performance comparison of the final product with predicate devices, not the training of a machine learning model.

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

As no training set is mentioned in the provided text, there is no information on how ground truth for a training set was established.

Summary

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February 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.

de Götzen S.r.l % Dario Bandiera Quality Manager via Roma, 45 Olgiate, Olona 21057 ITALY

Re: K192165

Trade/Device Name: Acteon Imaging Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 2, 2019 Received: January 13, 2020

Dear Dario Bandiera:

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) K192165

Device Name Acteon Imaging Suite

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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Image /page/3/Picture/0 description: The image shows the logo for ACTEON above an address. The address is "Via Roma, 45, 21057 Olgiate Olona (VA)". The ACTEON logo is in dark gray with a light blue swoosh above it.

510 (k) submission Section 3

Of February Rev. 4th2019 4.0

Index

SUBMITTER
DEVICE
PRIMARY PREDICATE DEVICE
SECONDARY PREDICATE DEVICE…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
DEVICE DESCRIPTION
Network functionalitiesI.
Data StoraqeII.
Exam formatIII.
HardwareIV.
INDICATIONS FOR USE
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Non clinical performance data:
INTERNAL DESIGN VERIFICATION AND VALIDATION TESTING
CONFORMANCE TO RECOGNIZED STANDARDS AND GUIDELINES
SUMMARY FOR ANY PERFORMANCE TESTING IN THE SUBMISSION
CONCLUSIONS

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Image /page/4/Picture/0 description: The image shows the logo for ACTEON, with the company name in bold, dark gray letters and a light blue curved line above the name. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)" in a simple, sans-serif font. The address is left-aligned and provides the location of the company.

The summary of this 510(k) is submitted in accordance with the requirements of 21 CFR Part 807.92.

SUBMITTER

Owner's name:	de Götzen S.r.l. – ACTEON Group
Address:	via Roma, 45 – 21057 Olgiate Olona (VA), Italy
Tel.	+39 0331 376760
Fax	+39 0331 376763
Contact Person:	Dario Bandiera – dario.bandiera@acteongroup.com
Date:	September 24th,2019

Table 1: Submitter

DEVICE

Name of the device:	Acteon Imaging Suite
Common or Usualname:	Imaging application software
Classification name:	Picture Archiving and Communication System(21 CFR 892.2050)
Regulatory class:	II
Product Code:	LLZ

Table 2: device

PRIMARY PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

PRIMARY PREDICATE DEVICE
Device name	Cliniview
Manufacturer	Palodex Group Oy
Device product code	LLZ
Regulation number	21 CFR 892.2050
Regulation name	Picture Archiving and Communication System
Clearance date	April, 25 2017
510(k) number	K162799

Table 3: primary predicate device

This predicate has not been subjected to a design-related recall.

Acteon Imaging Suite 510 (k) Summary

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Image /page/5/Picture/0 description: The image shows the logo for ACTEON, with the company name in bold, dark gray letters and a light blue swoosh above the name. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The address is in a simple, sans-serif font.

510 (k) submission Section 3

Rev. Of February 4th2019 4.0

SECONDARY PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

SECONDARY PREDICATE DEVICE
Device name	Planmeca Romexis
Manufacturer	Planmeca Oy
Device product code	LLZ
Regulation number	21 CFR 892.2050
Regulation name	Picture Archiving and Communication System
Clearance date	November, 14 2017
510(k) number	K171385

Table 4: secondary predicate device

This predicate has not been subjected to a design-related recall.

No reference devices were used in this submission.

DEVICE DESCRIPTION

Here below a scheme showing the main components of the device under analysis:

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Image /page/6/Figure/0 description: This image shows a diagram of the Acteon Imaging Suite. The diagram starts with the imaging device at the top, followed by the communication module. The communication module connects to the AIS GUI, which then connects to the data management, 2D viewer, and 3D viewer.

Figure 1: main components

The acquisition device communicates and transfer data to AIS through dedicated communication modules. These modules are specifically designed or rely completely on well-known and established Twain communication protocol.

AIS GUI consists of the following main parts:

Patient selection window .
Image /page/6/Picture/5 description: The image shows a patient data screen with a search patient function. The left side of the screen has a filter by section with a search bar. Below the search bar is a table with patient data including last name, first name, external ID, and DICOM ID. The right side of the screen shows patient information for Enrico Rossi, including a picture, date of birth (28/09/1901), address (Via Garibaldi 1), and a reference number.

Figure 2: Patient selection window

Patient selection window allows the user to search the patient folder and open related clinic view that contains all diagnostic acquired or imported images, report and so on.

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Image /page/7/Picture/0 description: The image contains the logo for ACTEON, which is in bold, dark gray font. Below the logo is the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The address is in a smaller, black font.

510 (k) submission Section 3 Of February Rev.

4th2019 4.0

. Clinic view
Image /page/7/Picture/5 description: The image shows a screenshot of a dental imaging software interface. On the left side, there is a panel with patient information and dental chart. The right side displays a panoramic X-ray image of a patient's teeth. The software interface includes various tools and options for dental imaging and analysis.

Figure 3: Clinic view

Clinic view allows to show all diagnostic images acquired or imported, report It is possible to filter the exam by date, exam type or by dental chart. Clinic view is the starting point to perform a new exam. It's also possible to open 3D viewer tool for 3D datasets or 2D viewer tool for 2D acquisitions.

2D App .

Image /page/7/Picture/9 description: The image shows a dental X-ray displayed on a computer screen. The X-ray reveals a full set of teeth, including molars, premolars, canines, and incisors, in both the upper and lower jaws. The image is captured using dental imaging software, as indicated by the application's interface visible on the screen.

Figure 4: 2D App

2D App is the tool to view 2D images. In that tool it is possible to adjust image, gamma, contrast, luminosity and sharpness. 2D App provides also tools to annotate the image.

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Image /page/8/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is a stylized text with a blue swoosh above it. The address is written in a simple, sans-serif font.

510 (k) submission Section 3 Rev. Of February

4th2019 4.0

3D App .
Image /page/8/Picture/5 description: The image shows a 3D rendering of a human jaw with teeth, along with a software interface for dental implant planning. The interface includes tools for implant placement, abutment design, and bone segmentation. The 3D rendering provides a detailed view of the jaw structure, while the software interface allows for precise planning of dental implant procedures.

Figure 5: 3D APP

3D App is the tool to view 3D volumes and plan implants. It is cleared under K173041 3DIEMME Ltd.

AIS Report Module .
Image /page/8/Picture/9 description: The image shows a dental x-ray report. The report includes patient information such as the patient's name, "DefaultLastName DefaultFirstName", and date of birth, "1/1/00". The report also includes the acquisition date of the x-ray, which is "6/26/15", and the report was edited on "5/20/19" by Dr. Clinical Case 1.

Figure 6: AIS report module

Report module provides the functionalities to allow the user to create customized reports, generating Portable Data Format (PDF) documents or printing directly on standard printers.

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Image: ACTEON logo
Via Roma, 4521057 Olgiate Olona (VA)

510 (k) submission Section 3 Rev. Of February 4.0 4th2019

AIS Configurator .
Image /page/9/Picture/4 description: The image shows a screenshot of the "AIS Configurator" software. The software's interface includes a menu bar with options like "File," "Administration," "Dicom," "Tools," "Configuration," and "License." Below the menu bar, there is a toolbar with various icons. The main area of the window displays a cartoon image of a blue bird standing next to a gear.

Figure 7: AIS configurator

This application is needed to manage database, change AIS general settings and set up PMS communication.

The data management component is needed to store patient data and images into AIS database and to manage them.

2D and 3D viewer are the tools required for data representation, both implement also image processing and measuring features.

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Image /page/10/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is in black with a blue swoosh above it. The address is in black text and is located below the logo. The background of the image is white.

Network functionalities I.

Acteon Imaging Suite has the possibility to be deployed in a Local Area Network (LAN) in a Client-Server architecture:

Clients are dedicated to exam retrieval, display and enhancement; .
Server is dedicated to store patient data and images, it provides also all the . functionalities available on the client.

Image /page/10/Figure/8 description: This image shows a diagram of a client-server network for dental imaging. The client side includes a dental imaging machine, a computer with dental imaging software, and dental tools. The server side includes a server and a database. The diagram shows that the client and server are connected via a network.

Communication between server and client is made in TCP/IP.

II. Data Storage

Exam data are stored on server Hard Drive Disk (HDD) or Solid Stated Drive (SSD) in anonymized image files.

Patient data are stored in crypted database to ensure privacy, the database file data are usually installed in the same drive of the exam data.

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Image /page/11/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is in black with a blue swoosh above it. The address is in black text and is located below the logo. The background of the image is white.

510 (k) submission Section 3

Acteon Imaging Suite provides the user with facilities for backup the data to prevent disk failure.

Exam format III.

Exam are saved both in Acteon proprietary format (DGI) as RAW or in standard format (TIF, JPG, PNG or DICOM).

The proprietary format (DGI) is used to give the user the possibility to apply different filters,

Hardware IV.

Acteon Imaginq Suite can be installed on every hardware compliant with the minimum requirements. No hardware is provided with the software.

Hardware, with Acteon Imaging Suite installed, can be provided by de Götzen S.r.l. – ACTEON Group with other Acteon Devices, for example X-MIND trium.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table here below contains a comparison of the technological characteristics

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Image /page/12/Picture/0 description: The image shows the logo for ACTEON. The logo features the company name in bold, dark gray letters. A blue curved line is above the company name. The text "Via Roma, 45" is below the logo.

510 (k) submission Section 3

Via Roma, 45 21057 Olgiate Olona (VA)

	Proposed	Predicate 1	Predicate 2
Feature	Acteon Imaging Suite(AIS)	Cliniview	Romexis
Manufacturer	de Götzen S.r.l. -ACTEON Group	KaVo	Planmeca
510(k)number	To be obtained	K162799	K171385
Indication foruse / intendeduse	Acteon ImagingSuite softwareprogram isindicated forgeneral dental andmaxillofacialdiagnosticimaging. It controlsexam retrieval,display,enhancement, andsaving of digitalimages fromvarious digitalimaging systems. Itstores andcommunicatesthese imageswithin the systemor across computersystems atdistributedlocations.	Cliniview softwareprogram isindicated forgeneral dental andmaxillofacialdiagnosticimaging. It controlscapture, display,enhancement, andsaving of digitalimages from digitalvarious imagingsystems. It storesand communicatesthese imageswithin the systemor across computersystems atdistributedlocations.	PlanmecaRomexis is amedicalimagingsoftware, and isintended foruse in dentaland medicalcare as a toolfor displayingand visualizingdental andmedical 2D and3D image filesfrom imagingdevices, such asprojectionradiographyand CBCT. It isintended toretrieve,process,render,diagnose,review, store,print, anddistributeimages.
	Proposed	Predicate 1	Predicate 2
Feature	Acteon Imaging Suite(AIS)	Cliniview	Romexis
Implementation	Software Only	Software Only	Software Only
Hostprocessorspeed	Intel Core i5 orbetter	Intel Core i3 orbetter	Processing IntelCore 2 Duo 2GHz or better
Host Monitorsize	Full HD	19" or largerrecommended	Full HD
Displayresolution	1600x1024	1280x1024resolution 24-bitcolor Monitor mustprovide abrightness of300cd/m2 forrooms <1000 luxand a minimumcontrast ratio of100:1	1280x1024(1920x1080recommended)
User DisplayPreferences	Yes	Yes	Yes
USB and SVideo Support	USB support	USB and S Videosupport	USB Support
Receiveimages fromother systems	Yes	Yes	Yes
Imagesdisplayed	2D and 3D dentalX-rays, intraoraland extraoralimages	2D dental x-rays,intraoral andextraoral images	2D and 3Ddental X-rays,intraoral andextraoralimages
Database	Image related dataare stored in theAIS database orremotely accessible	Images and relateddata are stored inthe Cliniviewdatabase or	Images andmetadata arestored in theRomexis
	Proposed	Predicate 1	Predicate 2
Feature	Acteon Imaging Suite(AIS)	Cliniview	Romexis
	database in thenetwork.	remotely accessibledatabase in thenetwork.	database.
Imageacquisition	Imaging platescanners, intraoralsensors, intraoralvideo camera,digital extra oral x-ray devices, variousimage file formats	Imaging platescanners, intraoralsensors, intraoralvideo camera,digital extra oral x-ray devices, variousimage file formats	Imaging platescanners,intraoralsensors,intraoral videocamera, digitalextra oral xraydevices, variousimage fileformats
Overallfunctionality	The imagingprogram for X-ray,color images andvideo cameras	The imagingprogram for X-rayand color images	The imagingsoftware fordigital imagingdevices andvideo cameras
Imageprocessingfunctionality	Enhancement,annotation,measurements,import/export andprinting image orreport files	Enhancement,annotation,measurements,import/export andprinting files.	Enhancementand archivingimages
Host platform	PC and Apple Mac	PC	PC and AppleMac
Hostoperatingsystem	Windows 7Ultimate/Professional (64-bit)Windows 8Professional (64-bit) Windows 1064-bit	Windows 7Professional/Ultimate/ EnterpriseSP1(32/64-bit)Windows 8/8.1Professional/Enterprise(32/64bit)	Windows 7Professional(32/64bit)Windows 8.1Professional(32/64bit)Windows 10 64-
	Proposed	Predicate 1	Predicate 2
Feature	Acteon Imaging Suite(AIS)	Cliniview	Romexis
	Windows Server2016Mac OS X (Intel)	Windows 10Windows Server2012/2012R2	bitWindowsServer 2008WindowsServer 2012Mac OS X (Intel)
Host RAM	8 GB	4 GB	Workstations:3/8 GBServers: 3/8 GB
Host magneticstorage	1 TB	8 GB free space 10GB hard diskdatabase	Workstations:80GBServers: 2x500GB
Host floppydrives	Not Required	Not Required	Not Required
Installationmedia	DVD or Network	DVD or Network	DVD ROM orR/W drive
Viewers/modes	Intraoral,Panoramic,CEPHALOMETRIC,2D lineartomographyphotos, Stackimages, 3D CBCT,3D photo, 3Dsurface scan	Intraoral,Panoramic,CEPHALOMETRIC,3D CBCT, colorphotographs	Intraoral,Panoramic,CEPHALOMETRIC,2D lineartomographyphotos,Stackimages, 3DCBCT, 3Dphoto, 3Dsurface scan

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Image /page/13/Picture/0 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in a bold, sans-serif font. A blue curved line is placed to the left of the word, adding a visual element to the logo. The logo is simple and modern.

510 (k) submission Section 3

Via Roma, 45 21057 Olgiate Olona (VA)

Of February Rev. 4th2019 4.0

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Image /page/14/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and the text is in all caps. There is a blue curved line above the text. Below the logo, the text "Via Roma, 45" is visible.

510 (k) submission Section 3

Via Roma, 45 21057 Olgiate Olona (VA)

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Image /page/15/Picture/0 description: The image shows the logo for ACTEON, which is written in bold, dark gray letters. A blue swoosh design is to the left of the company name. Below the logo, the text "Via Roma, 45" is written in black.

510 (k) submission Section 3

21057 Olgiate Olona (VA)

Implant library,

for implant

for implants,

which can be used

planning, searching

Implant planning Implant library,

for implant

searching for

planning,

which can be used

Optional

used for

implant

implant library,

which can be

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Image /page/16/Picture/0 description: The image contains the logo for ACTEON, a company that specializes in medical devices and equipment. The logo is a stylized wordmark with a blue swoosh above the letters. Below the logo is the text "Via Roma, 45".

510 (k) submission Section 3

Via Roma, 45 21057 Olgiate Olona (VA)

Feature	Proposed	Predicate 1	Predicate 2
	Acteon Imaging Suite(AIS)	Cliniview	Romexis
	implants, creatingnew implants,modifying, addingand replacingimplants in theplan	creating newimplants,modifying, addingand replacingimplants in the plan	planning,searching forimplants,creating newimplants,modifying,adding andreplacingimplants in theplan
Supportsmobileapplication	No	iPad application	iPad andiPhoneapplication

Table 5 Comparison between proposed and predicate devices.

Non clinical performance data:

The safety and effectiveness of Acteon Imaging Suite software have been evaluated via:

Internal design verification and validation testing; ●
Risk management; ●
Conformance to recognized standards and guidelines; ●
Cybersecurity risk management; .
Bench tests comparative on image processing. .

INTERNAL DESIGN VERIFICATION AND VALIDATION TESTING

Internal design verification and validation activities have been performed according to design and development internal procedure and configuration management plan taking into account requirements of

. IEC 62304 Medical device software - Software life cycle processes ed. 1.1: 2015
ISO 14971: Medical devices- Application of risk management to medical devices 2012
AAMI TIR57 2016 Principles for medical device security—Risk management

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Image /page/17/Picture/0 description: The image shows the logo for ACTEON, which is in a dark gray color with a light blue swoosh above it. Below the logo is the address "Via Roma, 45 21057 Olgiate Olona (VA)". The address is in a smaller font size than the logo.

510 (k) submission Section 3

and general principles of software validation included in Guidance for Industry and FDA Staff 2002

The person having the overall responsibility for this validation is independent of the design team, no member of the design team is responsible for the validation of their own design.

Protocol and acceptance criteria have been defined, revised and approved according to Software Validation Procedure that is written according to the standards above.

A specific software (TestRail) has been used to manage validation and traceability of AIS Traceability matrix and specific cybersecurity traceability matrix have been compiled

For each tested item have been defined the following aspects:

Purpose

Preconditions

Impact on safety and related control measure if any

Operative system where tested and role (client/server)

If regression test has been performed

Testing steps and related expected results.

Results of testing are reported in Software validation reports

Testing of all items that could affect safety of the device must have PASS as a result, while it is possible to release the software with minor anomalies. All the anomalies must be solved or justified before the release.

CONFORMANCE TO RECOGNIZED STANDARDS AND GUIDELINES

Acteon Imaging Suite is compliant with IEC 62304:2006/AMD1: 2015.

Software safety class is determined analyzing the harms that a software failure can cause, as described in the specific flow chart taken from IEC 62304:2006/AMD1: 2015. AIS is a Class B software following IEC 62304

therefore, all the requirements for a class B software have been satisfied.

Acteon Imaging Suite is compliant with IEC 60601-1-6; IEC 62366-1: 2013 The activities related to the usability process implementation have been conducted, following indications and rules of IEC 60601-1-6 and IEC 62366: 2015

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Image /page/18/Figure/0 description: This image is a flow chart titled "Figure 8: usability flow chart". The flow chart describes the usability process, starting with the definition of application specifications and ending with the residual risks associated with the usability of ME equipment being presumed to be acceptable. The flow chart also references RMF Subsections 7F and 7Q.

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Image /page/19/Picture/0 description: The image shows the Acteon logo above the address "Via Roma, 45 21057 Olgiate Olona (VA)". The Acteon logo is in black with a blue swoosh above it. The address is in black text and is located below the logo.

510 (k) submission Section 3

Rev. Of February 4th2019 4.0

Acteon Imaging Suite is compliant with NEMA PS 3.1 - 3.20 NEMA 12-300 Diqital Imaging and Communications in Medicine (DICOM) Set

SUMMARY FOR ANY PERFORMANCE TESTING IN THE SUBMISSION

Software is verified through unit, integration, system and architecture testing. Since the functionalities of AIS are the same of the predicate device ones and, since there are no significant technology differences, the equivalence has been demonstrated comparing the image rendering of different software with regards to the clinical effectiveness of that image.

Three independent reviewers having different backgrounds (maxillofacial surgery, orthodontics, dentistry) evaluated the same images, rendered on the same hardware (both Windows and MacOs) or printed with same printer, in order to evaluate the image quality (anatomical coverage, density and image contrast and anatomical structures) to assess suitability for clinical use.

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Image /page/20/Picture/0 description: The image shows the logo for ACTEON, with a blue swoosh above the name. Below the logo is the address "Via Roma, 45 21057 Olgiate Olona (VA)". The address is in a simple, sans-serif font.

510 (k) submission Section 3

CONCLUSIONS

Substantial equivalence:

There are no significant differences between the proposed device Acteon Imaging Suite and the predicates.

The proposed device is substantially equivalent to the predicate devices basing on:

Indication for Use statement; .
Offered functionalities; .
Theory of operations. .

All the hardware requirements of Acteon Imaging Suite are equal or more restrictive respect to the predicate devices.

The substantial equivalence has been demonstrated using bench tests that compare clinical suitability of the rendering performed by Acteon Imaging Suite with the predicates.

Acteon Imaging Suite is substantially equivalent to Cliniview software cleared under K162799 and Romexis cleared under K171385.

Minor differences in specifications do not affect safety and effectiveness of the 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).