X-MIND trium

• K Number: K160166
• Device Name: X-MIND trium
• Manufacturer: DE GOTZEN S.R.L.
• Date Cleared: 2016-11-15 ( 293 days)
• Product Code: OAS , MUH
• Regulation Number: 892.1750
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: K123381
• Predicate For: K191719 , K201667 , K222666

Intended Use

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in:

• producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;
• producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm;
• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
• producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, X-MIND trium can be applied for the following medical indications :

• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology

Device Description

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, which consists of:

1. Operator's workstation
2. X-MIND trium remote control and X-MIND trium light
3. X-MIND Trium medical device (Control panel, X-ray generator, Sliding body, U-arm, Detector sliding group, CBCT detector, PAN detector, Patient support, F group, Column)
   Cephalometric extension (CEPH arm extension, CEPH control panel, CEPH patient support, CEPH detector sliding group, CEPH secondary collimator, CEPH detector)
   Accessories (Temple rest, Chin rest, Sliding bite block and chin rest assembly, TMJ nose support, Calibration tray and geometric calibration phantom, Quality phantom support for Germany)

AI/ML Overview

The provided text is a 510(k) summary for the X-MIND trium device, which is a digital panoramic, cephalometric, and tomographic extra-oral X-ray system. The document compares the proposed device to a predicate device, the Hyperion X9, to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate device, Hyperion X9, as the acceptance criteria for substantial equivalence, particularly for image quality and radiation dose, while also assessing compliance with relevant safety standards. The table below summarizes the key performance comparisons presented as part of the substantial equivalence claim. Since specific numerical acceptance criteria (e.g., "must meet X value") are not explicitly stated as distinct criteria but rather as comparison outcomes, this table presents the comparative performance as reported.

Characteristic	Acceptance Criteria (Predicate Device - Hyperion X9)	Reported Device Performance (X-MIND trium)	Outcome
Cephalometric Image Quality	Test pattern images of certain quality	Test pattern images of equivalent quality	Substantial equivalence confirmed by metrics
Cephalometric Radiation Dose	Under DRL for Dental lateral cephalogram adult (32 mGycm²) according to NCRP Report No. 172 (2016)	Under DRL for Dental lateral cephalogram adult (32 mGycm²) according to NCRP Report No. 172 (2016)	Both Hyperion and X-MIND trium are under the DRL
Panoramic Image Quality	Test pattern images of certain quality	Test pattern images of equivalent quality	Substantial equivalence confirmed by metrics
Panoramic Radiation Dose	Under DRL for Dental panoramic (100 mGycm²) according to NCRP Report No. 172 (2016)	Under DRL for Dental panoramic (100 mGycm²) according to NCRP Report No. 172 (2016)	Both Hyperion and X-MIND trium are under the DRL
CBCT Image Quality (Standard Quality Protocols)	Homogeneity: baseline as Hyperion X9	Homogeneity: 2.8-10.9 times lower than Hyperion X9	Homogeneity for Hyperion is 2.8-10.9 times higher than X-MIND trium
	CNR: baseline as Hyperion X9	CNR: 2.12 ÷ 2.37 times higher than Hyperion X9	CNR for Trium is 2.12 ÷ 2.37 times higher than the CNR for Hyperion
	MTF: baseline as Hyperion X9	MTF plots show Trium better maintains high frequencies between 1.25 lp/mm and 1.5 lp/mm	Trium better maintains high frequencies
	Nyquist frequency: baseline as Hyperion X9	Equivalent	Equivalent
	Absence of artifacts: baseline as Hyperion X9	Equivalent	Equivalent
CBCT Radiation Dose (Standard Quality Protocols)	Similar to Hyperion X9, within reasonable variation	Lower than Hyperion X9, but X-MIND trium dose can be reduced by using other scan protocols (implicitly aiming for equivalence or improvement)	Hyperion is lower but the dose for X-MIND trium can be reduced by using other scan protocols (suggesting overall acceptable dose, though initially higher for some protocols if not adjusted)
CBCT System Indicator ($S_{DAP}$)	Substantial equivalence to Hyperion X9	Calculated $S_{DAP}$ value (not explicitly reported but claimed to establish equivalence)	Substantial equivalence is confirmed by $S_{DAP}$
CBCT Image Quality (High Quality Protocols)	Noise: baseline as Hyperion X9	Voxel noise for Hyperion is 43.5% ÷ 53.8% higher than Trium	Voxel noise for Hyperion is higher than Trium (implying Trium has lower noise)
	NPS: baseline as Hyperion X9	Noise content very similar at low frequencies, Hyperion shows higher noise at medium and high frequency	Hyperion shows higher noise at medium and high frequencies (implying Trium has lower noise)
CBCT Radiation Dose (High Quality Protocols)	Substantial equivalence to Hyperion X9	Metrics confirmed substantial equivalence	Substantial equivalence is confirmed by metrics
Electrical Safety & EMC	Compliance with IEC 60601-1 3rd ed., IEC 60601-1-2: 2007, etc. (as per predicate)	Compliance with same standards, plus US and Canada deviations (IEC 60601-1 deviations for US and Canada), IEC 60601-1: 2007, ANSI/AAMI ES60601-1: 2005, CAN/CSA C22.2 No. 60601-1:08, IEC 60601-1-3: 2008, IEC 60601-2-63: 2012, IEC 60601-1-6: 2010, IEC 62366: 2007	Met and exceeded standards, with formal certifications from NRTLs.
Software Verification & Validation	As recommended by FDA Guidance	Documentation provided as recommended by FDA Guidance for software in medical devices	Software considered "moderate" level of concern, V&V testing conducted. General tools and means made available by both software are equivalent.

2. Sample size used for the test set and the data provenance:

The document mentions that "bench tests" were performed for image quality and radiation dose. It refers to "test pattern images" and "clinical images obtained with X-MIND trium and predicate device." However, the sample size for the test set (number of images/cases) is not explicitly stated.

The data provenance is likely retrospective, as the comparison involves existing images from the predicate device and newly generated images from the X-MIND trium under controlled bench test conditions. The country of origin of the data is not specified but given the manufacturer's location in Italy and the use of a Nationally Recognized Testing Laboratory (NRTL) (Intertek Semko, Nemko S.p.A.), it is likely that the testing was performed in Europe.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

The document does not mention the use of human experts to establish ground truth for the test set. The image quality assessments appear to be based on objective metrics derived from phantom studies (e.g., homogeneity, CNR, MTF, Nyquist frequency, artifacts, NPS), rather than subjective evaluations by clinical experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as human expert evaluation for ground truth determination is not described. The assessment was based on objective metrics from bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an X-ray imaging system, not an AI-assisted diagnostic tool. The focus of the submission is on hardware and software equivalence for image acquisition and display, not on reader performance improvement with AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, standalone performance was done, but not in the context of an "algorithm" as typically conceived in AI/ML performance. The "device performance" described (image quality metrics, radiation dose, electrical safety, EMC) is the performance of the X-MIND trium system itself in a standalone capacity, i.e., without human intervention in the image generation part of the test. The "software" component also underwent verification and validation, but this refers to its functionality and reliability in image management and processing features available to the user, not an AI algorithm performing diagnostic tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance evaluation mostly relies on objective physical measurements and phantom studies. For image quality, metrics like homogeneity, CNR, MTF, Nyquist frequency, and NPS derived from test patterns or phantoms serve as the "truth" against which the device's imaging capabilities are measured. For radiation dose, established Dosimetry Reference Levels (DRLs) from NCRP REPORT No. 172 (2016) serve as the standard. For electrical safety and EMC, recognized international standards (e.g., IEC 60601 series) are the ground truth for compliance.

8. The sample size for the training set:

Not applicable. The device is an X-ray imaging system, not an AI/ML diagnostic algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable. As stated above, this device does not involve a training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles connected by flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2016

de Götzen S.r.l. % Mr. Olivier Balouka Legal Representative Via Roma, 45 Olgiate Olona, Varese 21057 ITALY

Re: K160166 Trade/Device Name: X-MIND trium Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS, MUH Dated: October 14, 2016 Received: October 26, 2016

Dear Mr. Balouka:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160166

Device Name X-MIND trium

Indications for Use (Describe)

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;

• producing radiographs of maxillofacial region and parts of the skull for cephalometric exammation, if equipped with CEPH arm:

• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm:

• producing tomographic mages of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), aws. oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, the X-MIND trium can be applied for the following medical applications:

• · Generic dentistry
• · Dental implantology
• · Dental surgery
• · Maxillo-facial surgery
• · Cephalometric analysis
• · Carpus radiology

The intended population can be whatever, including pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to X-ray exposure must be evaluated by qualified and authorized physicians, surgeons and dentists.

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

X 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: This image is a table with three columns. The first column contains the logo for ACTEON, the address Via Roma, 45, and the city 21057 Olgiate Olona (VA). The second column contains the text X-MIND trium and 510 (k) Summary. The third column contains the text 510 (k) submission Section 5, Ed. 3.0, and Of October 3rd, 2016.

510 (k) Summary

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

I. SUBMITTER

Owner's name:	de Götzen S.r.l. – ACTEON Group
Address:	via Roma, 45 – 21057 Olgiate Olona (VA), Italy
Tel.	[phone]
Fax	[phone]
Contact Person:	Olivier Balouka – [e-mail] Bandiera – [e-mail]
Date:	October 3rd, 2016

II. DEVICE

Name of the device:	X-MIND trium
Common or Usualname:	Dental panoramic, cephalometric and CBCT X-raysystem
Classification name:	Computed tomography X-ray system (21 CFR 892.1750)
Regulatory class:	II
Product Code:	OAS, MUH

III. PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

PREDICATE DEVICE
Device name	Hyperion X9
Manufacturer	CEFLA S.C.
Device product code	OAS
Subsequent product code	MUH
Regulation number	892.1750
Regulation name	Computed tomography x-ray system
Clearance date	05/10/2013
510(k) number	K123381

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de GötzenACTEONVia Roma, 4521057 Olgiate Olona (VA)	X-MIND trium510 (k) Summary	510 (k) submissionSection 5Ed. 3.0 Of October 3rd, 2016
-----------------------------------------------------------------	---------------------------------	-----------------------------------------------------------------

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

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, which consists of:

Image /page/4/Figure/5 description: The image shows a diagram of a dental X-ray machine and its connections to other devices. The diagram includes a computer labeled as '1', a control panel labeled as '2', a power supply labeled as '3', and the X-ray machine itself labeled as '4'. Lines connect the X-ray machine to the computer, control panel, and power supply, indicating a connection between these components.

1. Operator's workstation

The operator's workstation is provided optionally for the PAN only unit. The workstation allows the operator to perform the following procedures:

• Calibration of the medical device
• · Acquisition parameters setting
• Radiological image acquisition
• · Image visualization and post processing
• · Periodic quality Tests

The workstation must have installed the following modules:

• · ACTEON IMAGING SUITE (AIS) equipment management software + 2D diagnostic analysis
• · AIS 3D app (CBCT)

Communication with the medical device occurs by means of Ethernet protocol.

2. X-MIND trium remote control and X-MIND trium light

X-MIND trium Remote Control

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0	Of October 3rd,2016

The X-MIND trium remote control must be located in a safe place protected against radiations, in compliance with the local standards in force concerning ionizing radiation protection.

The X-MIND trium remote control allows the operator to activate or deactivate X-ray emission from the control room. This consists of two switches, one for exposure and one for emergency, which control device operation.

X-MIND trium Light

Image /page/5/Picture/4 description: The image shows a white, wall-mounted device with a red, translucent cover. The device appears to be an alarm or warning system, possibly a fire alarm or emergency alert system. The red cover is curved and protrudes from the white base, suggesting it may house a light or other signaling mechanism. The device is mounted on a white surface.

The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress. It indicates no entry into the room when the red light is on; it also has a triangular danger sign that warns of X-ray hazards.

3. X-MIND Trium medical device

Overview of the medical device: PAN/CBCT model:

Image /page/5/Figure/8 description: The image shows a dental X-ray machine with several parts labeled with numbers. The labels point to the control panel (1), the arm (2), the top of the machine (3), the upper part of the head support (4), the head support (5), the head support adjustment knob (6), the lower part of the head support (7), the chin rest (8), the body of the machine (9), and the base of the machine (10).

The X-MIND trium medical device for PAN/CBCT models consists of the following parts:

• Control panel. The control panel provides an intuitive overview of the system 1. to move the mobile column, move the bite block holder (only PAN/CBCT version), move the U-arm, turn the positioning lasers on and off and activate the X-MIND trium medical device.

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	de Götzen ACTEON
	X-MIND trium
	510 (k) Summary
Via Roma, 45	510 (k) submission
21057 Olgiate Olona (VA)	Section 5
	Ed. 3.0
	Of October 3 rd , 2016

• 2. X-ray generator. The X-ray assembly is the source of the X-ray beam. An automatic collimator shapes the X-Ray beam, whereas the electronic control ensures stability and accuracy of the selected loading factors (exposure time, kVp and anodic current). A filter is used to harden the beam and remove lowenergy ionizing radiations, thereby obtaining suitable radiation quality whilst reducing the dose absorbed by the patient; the filter's material is aluminium for PAN and CEPH exams, aluminium + copper for CBCT exams.
• 3. Sliding body. The sliding body is the mobile part of the column that supports U-arm.
• 4. U-arm. The U-Arm supports the PAN/CBCT Detector sliding group and the Xray generator. This is the rotating and translating part of the medical device, which moves around the patient during the image acquisition phase; it can as well be moved in two horizontal directions (X and Y) by the operator during the setup of the exam, in order to obtain the best superimposition between the patient's head anatomy and the diameter of the Field of View (FOV).
• 5. Detector sliding group. It contains detectors that acquire PAN and CBCT images.
• 6. CBCT detector. Dedicated detector for CBCT acquisition.
• 7. PAN detector. Dedicated detector for PAN acquisition.
• Patient support. The patient support allows stabilising and immobilising the 8. patient. It can be moved vertically in order to obtain the best superimposition between the patient's head anatomy and the height of Field of View (FOV).
• 9. F group. It is the whole assembled mobile group of the device. It is the moving part of the medical device, which adapts the acquisition geometry to the patient's anatomy and stance (sitting or standing). It supports the U-Arm and head support.
• 10. Column. The fixed column supports the entire structure of the medical device. This contains the motor that raises the F Group.

Overview of the medical device: Cephalometric extension:

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de GötzenACTEON	X-MIND trium		510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0	Of October 3rd,2016
	111213141516

The Cephalometric version of X-MIND trium medical device consists of the parts listed above and of the following additional parts:

11. CEPH arm extension. Can be positioned both on the right or left side of the vertical column.

12. CEPH control panel. Provides an intuitive overview of the system to move the mobile column and activate the X-MIND trium medical device.

13. CEPH patient support. Allows stabilising and immobilising the patient during CEPH exams, by means of ears rest and nasion rest.

14. CEPH detector sliding group. Enables to slide the detector to follow the X-Ray beam.

15. CEPH secondary collimator is positioned on the U-arm; it translates during X-Rays (keeping aligned the X-Ray beam emerging from the tube head with the CEPH detector);

16. CEPH detector. Gives 2D image of the whole patient head; this detector can optionally be moved from his position on CEPH arm to the PAN position on the U-arm.

The whole equipment is manufactured according to the international requlations in force relevant to ionizing radiation protection as well as mechanical and electrical safety concerning electro medical devices.

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Image /page/8/Picture/0 description: The image shows a document with the title "X-MIND trium 510 (k) Summary". It includes the text "510 (k) submission Section 5 Of October 3rd, 2016 Ed. 3.0". The document also contains the address "Via Roma, 45 21057 Olgiate Olona (VA)" and the Acteon logo.

Control panels

Equipment control panels are used during patient positioning phase.

Proper keys allow to move equipment to the initial position before patient access, turn on the positioning lasers, adjust the U-arm position to align the patient to Xray beam and set the "ready to X-ray" status.

Some keys are duplicated on the CEPH control panel, for use during patient positioning for CEPH exams.

Image /page/8/Picture/5 description: The image shows a control panel with a variety of buttons and a small display screen. The top portion of the panel is black, while the lower portion is white. The buttons are arranged in a grid-like pattern, with directional arrows and other symbols. The brand name ACTEON is visible at the bottom of the panel.

Equipment control panel

Image /page/8/Picture/7 description: This image shows a CEPH control panel. The panel has a white background with a black border. The panel has the words "X MIND trium" in the upper right corner. There are up and down arrow buttons on the left side of the panel, and a check mark button on the right side.

CEPH control panel

X-MIND trium remote control

The X-MIND trium remote control must be kept in a safe place protected against radiations, in compliance with local standards in force concerning radiation protection. The X-MIND trium remote control allows the operator to activate or deactivate X-ray emissions from the control room.

The components are listed below with a brief description of the parts.

1. Safety key selector switch. Deactivates the X-ray emission switch to prevent accidental exposure.

2. X-ray emission LED. Remains on during the entire acquisition.

3. Remote emergency switch. Allows stopping the device in the event of emergency.

4. X-ray emission switch. Activates acquisition.

Emergency switches

This device is equipped with two emergency switches that allow to stop the movement of parts and X-ray emission in the event of an emergency.

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0
		Of October 3rd, 2016

Patient emergency switch

Image /page/9/Picture/2 description: The image shows two pieces of medical equipment. The equipment on the left is a white, tall machine with a rectangular head and a cylindrical base. The equipment on the right is a white chair with a headrest and armrests. A red line connects the two pieces of equipment, indicating a relationship between them.

The patient emergency switch is installed on the head support and is within the patient's reach, to allow both the patient and the operator to stop the device in the event of panic or hazards, sudden column motion or any anomaly. The operator must inform and instruct the patient on the emergency procedures and on the use of the emergency switches of the device, as indicated in this chapter.

Remote emergency switch

Image /page/9/Picture/5 description: The image shows a top-down view of a gray, square-shaped electronic device. The device has a large, red circular button on the upper right corner. There is also a small yellow screen in the center of the device, and a dial on the upper left corner.

1= Remote emergency switch

The Remote emergency switch is located on the X-MIND trium remote control. In case of an emergency, stop any movement of the device and X-ray emission by pressing either the patient emergency switch or the remote emergency switch. This action puts the device in the emergency status.

To reset the emergency status, first solve the emergency condition and then release the emergency switch by turning it clockwise until it reaches its initial position.

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Image /page/10/Picture/0 description: This image contains the company logo for ACTEON, along with the company address, Via Roma, 45 21057 Olgiate Olona (VA). The image also contains the text X-MIND trium and 510 (k) Summary. The image also contains the text 510 (k) submission Section 5 Of October 3rd, 2016 Ed. 3.0.

X-ray exposure switch

Image /page/10/Picture/2 description: The image shows a gray, square-shaped device with a red button on the top right corner. There is a small, yellow screen in the center of the device. An arrow points to the yellow screen, indicating it as a key feature. The device also has a circular opening on the top left corner.

X-ray exposure switch

To activate the exposure, the operator must press and hold the X-ray exposure switch for the entire acquisition. Meanwhile, the yellow X-ray exposure LED stays on to indicate the X-ray emission.

If the operator removes his/her finger from the exposure button before the acquisition is complete, the X-ray emission and U-arm rotation will be interrupted and the X-ray exposure LED will turn off. At this point, an error message appears in the AIS software. This message must be closed before using the medical device aqain.

Head support for PAN/CBCT exams

The head support positions and immobilizes the patient before the scan. It is equipped with a chin rest and forehead support to ensure maximum stability.

Image /page/10/Figure/8 description: This image shows a close-up of a white machine with several numbered red dots indicating different parts. The numbers range from 1 to 8, suggesting a detailed breakdown of the machine's components. The machine appears to be a medical or laboratory device, given its complex structure and various tubes and containers. The focus is on the internal mechanisms and connections within the machine.

• 1. Temple rest
• 2. Patient mirror
• 3. Local emergency switch
• 4. Courtesy tray
• 5. Handlebar
• 6. Temple knob
• 7. Chin rest
• 8. Bite block

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Image /page/11/Picture/0 description: The image is a document containing information about a 510(k) submission for X-MIND trium. It includes the company's logo, Acteon, and address, Via Roma, 45, 21057 Olgiate Olona (VA). The document is Section 5 of the 510(k) submission, edition 3.0, and is dated October 3rd, 2016.

Head support for CEPH exams

The head support in CEPH arm positions and immobilizes the patient before the scan. It is equipped with a couple of ear rests and a nose support to ensure maximum stability.

Image /page/11/Picture/3 description: The image shows a close-up of a piece of equipment with three red lines pointing to different parts. The red line labeled '1' points to a metal arm extending downwards. The red line labeled '2' points to another metal arm, and the red line labeled '3' points to a vertical metal rod.

• 1. Ear rest
• 2. Ear rest knob
• 3. Nose support

To adapt to the patient's anatomy, the CEPH head support is equipped with:

• · Ear rest knob for horizontal ear rest movement
• Nose support that can be manually moved in horizontal and in vertical.

Accessories

Temple rest

The temple rest supports provide support, frontal and lateral stability to the patient's head for all types of examination.

Image /page/11/Picture/13 description: The image shows a close-up of a white medical device with the words "TEMPLE REST" written below. Two red lines highlight the temple rest area of the device. The device appears to be used for eye exams or procedures.

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Image /page/12/Picture/0 description: This image shows a document with the title "X-MIND trium 510 (k) Summary". The document also includes the address "Via Roma, 45 21057 Olgiate Olona (VA)". The document is a 510(k) submission, section 5, edition 3.0, and is dated October 3rd, 2016.

Chin rest

Image /page/12/Picture/2 description: The image is a close-up shot of a white object with a clear, rectangular component on top. The clear component appears to be made of plastic or glass and has a slightly curved shape. The white object has a smooth, rounded surface with some visible details, such as a thin line around the edge. The image is well-lit, and the focus is on the clear component, which reflects light and creates a sense of depth.

The chin rest allow immobilizing the patient's mouth during the 3D CBCT and the 2D maxillary sinus exams; it should also be used for 2D panoramic exams in case of edentulous patients.

Sliding bite block and chin rest assembly

Image /page/12/Picture/5 description: The image is a close-up shot of a humidifier. The humidifier is white and has a clear water tank on top. The water tank is partially filled with water. The humidifier is sitting on a white surface.

The combined use of the bite block and the chin rest improves the stability of the iaws, allows separating the teeth during the acquisition and places in the same vertical plane the superior and the inferior incisors.

The bite block and chin rest assembly must be used for immobilizing the patient in panoramic exams except in case of edentulous patients; in addition, it can be used in CBCT scans when an improved 3D reconstruction of the dental crown surface is required.

TMJ nose support

This support must be used for TMJ examinations since it is specifically designed to stabilize the patient's head in both open mouth and closed mouth conditions.

Calibration tray and geometric calibration phantom

The Calibration tray is used to position the geometric calibration phantom during the calibration procedure of the CBCT apparatus.

The calibration procedure consists of a scan of the calibration phantom and the estimation of a set of parameters that describe the configuration of the system.

Quality phantom support for Germany

This accessory is intended to position the QUART DVT test phantoms for QA/QC of CBCT functionality for X-MIND trium installed in Germany.

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Image /page/13/Picture/0 description: The image is a document that appears to be a 510(k) submission summary for a product called "X-MIND trium". The document includes the address "Via Roma, 45, 21057 Olgiate Olona (VA)". The document is marked as Section 5, Edition 3.0, and dated October 3rd, 2016.

X-MIND trium configurations

X-MIND trium can be sold in these configurations:

PAN only

• The equipment can carry out uniquely exams of the PAN group (PAN, TMJ, . Sinus).
• . The image detector is fixed to the PAN bay.
• All the exams are carried out with the same extension in height (146 mm ● height on imaqe receptor), since the collimator has fixed dimensions.
• . The equipment can be upgraded in a later stage by replacing and adding several parts.

PAN and CBCT

• . The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group.
• . There are two image detectors, one for PAN and one for CBCT exam; the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam.
• PAN exams can be carried out with different extension in height (up to 146 mm height on image receptor), since the collimator height can be adjusted depending on the exam selected by the user.
• . CBCT exams can be carried out at different FOV dimensions as specified in the technical data appendix.
• The equipment can be upgraded in the field to CEPH configuration by simple procedure, adding CEPH arm with CEPH image detector and replacing the existing PAN image detector.

PAN / CEPH

• . The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CEPH group (AP/PA, LL, carpus).
• The image detector can optionally be unique, for both PAN and CEPH exams; . in this case it must be manually moved by the operator from PAN bay to CEPH bay and vice versa, depending on the selected exam. Otherwise, two different dedicated detectors can be provided: one for CEPH exams and the other one for PAN exams.
• The exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on exam selected by the user.

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0	Of October 3rd, 2016

• The equipment can be upgraded in-field to CBCT configuration by a simple . procedure, adding the CBCT image detector and the bite block holder with vertical movement.

PAN / CBCT / CEPH

• . The equipment can carry out all feasible exams of the PAN group (PAN, TMJ, Sinus), CEPH group (AP/PA, LL, carpus) and CBCT group.
• . There are optionally two image detectors, one for PAN/CEPH and one for CBCT exams; in this case the PAN/CEPH image detector must be manually moved by the operator from PAN bay to CEPH bay and vice versa; otherwise three image detectors, one for PAN, one for CEPH and one for CBCT exams.
• . To carry out PAN or CEPH or CBCT exams the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam.
• PAN and CEPH exams can be carried out with different extension in height (up to 146 mm height on image receptor for PAN, up to 220 mm height on image receptor for CEPH), since the primary collimator can be automatically adjusted in height depending on exam selected by the user;
• . CBCT exams can be carried out at different FOV dimensions as specified in the technical data appendix.

Exams

In its different configurations, X-MIND trium equipment carries out the following exams:

Panoramic group

The panoramic group includes all the 2D radiographs of the jaws, dentition, temporomandibular joints and maxillary sinuses.

• 1. Standard panoramic
  • Full scan
  • · Right side only
  • Left side only
• 2. Sectorial panoramic with improved orthogonality
  • . Full scan
  • Right side only .
  • Left side only .
• 3. Frontal panoramic
• 4. Bitewings

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Image /page/15/Picture/0 description: This image is a document that contains the company logo and address on the left side. The company logo is "ACTEON" in blue and green. The address is "Via Roma, 45 21057 Olgiate Olona (VA)". The document also contains the title "X-MIND trium 510 (k) Summary" in bold. On the right side, it contains the text "510 (k) submission Section 5 Ed. 3.0 Of October 3rd, 2016".

• 5. Frontal temporomandibular joint with closed or open mouth
  • Both sides .
  • Left TMJ only .
  • Right TMJ only .
• 6. Lateral temporomandibular joint with closed or open mouth
  • Both sides ●
  • . Left TMJ only
  • Right TMJ only
• 7. Frontal maxillary sinuses
• 8. Lateral maxillary sinuses
  • Left sinus only .
  • . Right sinus only

CBCT group

The CBCT group includes all the 3D CBCT examinations of the dental and maxillofacial regions.

Here below the size of the reconstructed volumes expressed as diameter x height.

• 1. Dental FOV
  • 40mm x 40mm
  • 60mm x 60mm
  • 80mm x 80mm
  • 110mm x 80mm
• 2. ENT FOV Nose
  • 110mm x 80mm
• 3. ENT FOV Ear
  • Left ear only, 60mm x 60mm
  • . Right ear only, 60mm x 60mm

Cephalometric group

• 1. Frontal (AP/PA)
• 2. Lateral (LL)
• 3. Hand acquisition (Carpus special support needed)

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de G ötzen
ACTEON

510 (k) submission Section 5

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

V. INDICATIONS FOR USE

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, indicated for use in:

• producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures;

producing radiographs of maxillofacial region and parts of the skull for ı cephalometric examination, if equipped with CEPH arm;

• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;

• producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.

From a clinical point of view, X-MIND trium can be applied for the following medical indications :

• · Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• · Carpus radiology

The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to Xray exposure must be evaluated by surqeons, dentists and qualified and authorized physicians.

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Image /page/17/Picture/0 description: The image contains the logo for Acteon. The logo is blue and has a green swoosh on the left side. Above the word Acteon is the text "de Gotzen" in a smaller font.

510 (k) submission Section 5

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

Of October 3rd, Ed. 3.0 2016

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	Proposed	Predicate
Characteristic	X-MIND trium	HYPERION X9
Manufacturer	de Götzen S.r.l. - ActeonGroupVia Roma, 4521057 Olgiate OlonaVA - Italia	Cefla s.c.Via Selice Prov.le, 23/a40026 ImolaBO - Italia
510 (k) number	K160166	K123381
Indication foruse	X-MIND trium is a digitalpanoramic, cephalometric andtomographic extra-oral X-raysystem, indicated for use in:- producing panoramic X-rayimages for diagnosticexamination of dentition(teeth), jaws and oralstructures;- producing radiographs ofmaxillofacial region and partsof the skull for cephalometricexamination, if equipped withCEPH arm;- producing radiographs ofhands and wrists for carpusexamination, if equipped withCEPH arm;- producing tomographicimages of the oral andmaxillofacial region, fordiagnostic examination ofdentition (teeth), jaws, oralstructures and some cranialbones, if equipped with CBCToption.	Hyperion X9 is a digitalpanoramic, cephalometricand tomographic extra-oralX-ray system, indicated foruse in:Producing panoramic X-rayimages of the maxillo-facial area, for diagnosticexamination of dentition(teeth), jaws and oralstructures;Producing radiographs ofjaws, parts of the skull andcarpus for the purpose ofcephalometric examinationwith tele-radiographic arm(CEPH);Producing tomographicimages of the oral andmaxillofacial structure, fordiagnostic examination ofdentition (teeth), jaws,oral structures and somecranial bones if equippedwith CBCT option.
	Proposed	Predicate
Characteristic	X-MIND trium	HYPERION X9
	From a clinical point of view,X-MIND trium can be appliedfor the following medicalindications:	From a clinical point of view,X-MIND trium can be appliedfor the following medicalindications:
	Generic dentistry	Generic dentistryConservative dentistry:• Endodontics;• Periodontology;• Dental prostheses;Orthodontics.
	Dental implantology	Dental implantologyImplantation
	Dental surgery	Dental surgerySurgical dentistry
	Maxillo-facial surgery	Maxillo-facial surgeryMaxillofacial surgery
	Cephalometric analysis	Cephalometric analysisFunctional diagnostics andtreatment of craniomandibulardysfunctions
	Carpus radiology	Carpus radiology
	The target patient populationincludes adults and pediatricpatients from 5 years old[~21 kg (46 lb); 113 cm(44.5 in) standing height];anyway the sustainability toX-ray exposure must beevaluated by surgeons,dentists and qualified andauthorized physicians.	The target patient populationincludes adults and pediatricpatients from 5 years old[~21 kg (46 lb); 113 cm(44.5 in) standing height];anyway the sustainability toX-ray exposure must beevaluated by surgeons,dentists and qualified andauthorized physicians.
Performance	1) Panoramic2) Cephalometric (optional)	1) Panoramic2) Cephalometric (optional)
specifications	3) CBCT (optional)	3) CBCT (optional)
Exam mode	1) PAN:- standard panoramic- child panoramic- TMJ	1) PAN- standard panoramic- child panoramic- TMJ
Characteristic	ProposedX-MIND trium	PredicateHYPERION X9
	- bitewing- sectorial panoramic withimproved orthogonality- maxillary sinuses2) CEPH:- frontal (AP/PA)- lateral (LL)- hand acquisition - carpus(special support needed)3) CBCT:- full view- extended view	- bitewing- sectorial panoramic- maxillary sinuses2) CEPH:- frontal (AP/PA)- lateral (LL)- carpus (with special handsupport)3) CBCT:- full view- extended view
Device power supply
Type of power supply	Single-phase alternatingcurrent power supply	Single-phase alternatingcurrent power supply
Nominal voltage	100 V - 240V	115 V - 240 V
Maximum voltage variation	$\pm$ 10%	$\pm$ 10%
Nominal current	7 A (@ 240 V)15 A (@ 100 V)	7 A (@ 240 V)14 A (@ 115V)
Frequency	50 - 60 Hz	50 - 60 Hz
Operation mode	Continuous operation withintermittent X-ray loading	Continuous operation withintermittent X-ray loading
Electrical classification (IEC 60601-1)
Protection againstelectrical shock	Class I	Class I
Degree of protectionagainstelectrical shock	Type B	Type B
EMC classification
Emission	Group 1, Class A	Group 1, Class B
Characteristic	Proposed	Predicate
	X-MIND trium	HYPERION X9
X-RAY source assembly
Manufacturer of the X-ray tube	CEI	CEI
X-ray tube model	OPX/105	OPX/105
Nominal High Voltage	60 - 85 kV for PAN/CEPH80 - 90 kV for CBCT	60 - 85 kV for PAN/CEPH80 - 90 kV for CBCT
Anode heat storage capacity	30 kJ	30 kJ
Nominal focal spot diameter	0.5 mm	0.5 mm
Anode material	Tungsten	Tungsten
Target Angle	5°	5°
Anodic current	4 - 10 mA for PAN/CEPH4 - 12 mA for CBCT	4 - 10 mA
Total filtration	2.8 mm Al for PAN/CEPH at 85 kV7.0 mm Al for CBCT at 90 kV	3.2 mm Al for 2D mode at 85 kV6.2 mm Al for 3D mode at 85 kV
HVL	3.4 mm Al for PAN/CEPH at 85 kV5.2 mm Al for CBCT at 90 kV	3.6 mm Al for PAN/CEPH at 85 kV5.0 mm Al for CBCT at 90 kV
Accuracy of the load parameters
High Voltage	kV ± 10%	kV ± 10%
Current in the tube	mA ± 20%	mA ± 20%
Exposure time seconds	Seconds ± (10% + 1ms)	Seconds ± (10% + 1ms)
PAN/CEPH detector
Detector technology	CMOS	CCD
Detector manufacturer	Hamamatsu
Detector model	PAN: C10500D-42CEPH: C10502D-42
Pixel size	100 μm	48 μm(in PAN and CEPH exams the
Characteristic	ProposedX-MIND trium	PredicateHYPERION X9
Image size	PAN: 1480 px x 2658 pxCEPH: 2232 px x 2673 px	PAN: 1528 px x 2797 pxCEPH: 2291 px x 3125 px
Active area	PAN: 148 mm x 6 mmCEPH: 220 mm x 6 mm	PAN: 146 mm x 6 mmCEPH: 220 mm x 6 mm
Theoreticaldetector	4.5 lp/mm	10.4 lp/mm (@48 µm pixelsize)
Actual in imaging¹	4.5 lp/mm	5-7 lp/mm (@96 µm pixel size)
Detectorresolution²:	PAN: high contrastresolution: 3.1 lp/mmPAN: low contrast resolution:similar performanceCEPH: high contrastresolution: 3.1 lp/mmCEPH: low contrast resolutionsimilar performance	PAN: high contrastresolution: 2.8 lp/mmPAN: low contrast resolution:similar performanceCEPH: high contrastresolution: 3.1 lp/mmCEPH: low contrast resolutionsimilar performance
X-ray exposuretime	PAN: 13.5 sCEPH:18 s	PAN: 7.5 s - 13 sCEPH: 3.4 s
CBCT detector
Detectortechnology	Flat panel CMOS	Flat panel CMOS
Detectormanufacturer	Hamamatsu
Detector model	C12280D-40
Image voxelsize	75 µm (minimum slicethickness)	75 µm (minimum slicethickness)
FOV (diameter xheight)	40 mm x 60 mm60 mm x 60 mm	50 mm x 50 mm80 mm x 50 mm
Characteristic	ProposedX-MIND trium	PredicateHYPERION X9
	80 mm x 80 mm110 mm x 80 mm	80 mm x 80 mm110 mm x 50 mm110 mm x 80 mm110 mm x 130 mm
Detectorresolution²:	High contrast resolution:V10%: 1.61 lp/mm:High contrast resolution:V50%: 0.66 lp/mm	High contrast resolutionV10%: 1.27 lp/mmHigh contrast resolution:V50%: 0.69 lp/mm
Rotation	360°	360°
Scanning time	12 s to 30 s maximum	18 s to 36 s maximum
X-ray realexposure time	6s (Normal quality)7.2s (Medium quality)9s (High quality)	3.6 s (High resolution)9.0 s (Peak resolution)
	Device mechanical data
Dimensions	Footprint:PAN/CBCT: max 1100 mm x 1500 mmWith CEPH: max 1720 mm x 1500 mmHeight: 2350 mm	Footprint: max 1830 mm x 1520 mmHeight: 2400 mm
Weight	PAN: 170 kgPAN/CBCT: 185 kgPAN/CBCT With CEPH: 215 kg	PAN/CBCT: 170 kgWith CEPH: 190 kg
Mechanicalconfiguration	Wall mount	Wall or floor support, freestanding base available.
Patient position	Standing, seated or on wheel-chair	Standing, seated or onwheel-chair
Applicable Standards
	IEC 60601-1 3rd ed.	IEC 60601-1 3rd ed.
	ANSI/AAMI ES60601-1: 2005
	CAN/CSA C22.2 No. 60601-1:08
	IEC 60601-1-2: 2007	IEC 60601-1-2: 2007
	IEC 60601-1-3: 2008	IEC 60601-1-3: 2008
	IEC 60601-2-63: 2012	IEC 60601-2-63: 2012
	IEC 60601-1-6: 2010	IEC 60601-1-6: 2010
Characteristic	Proposed	Predicate
	X-MIND trium	HYPERION X9
	IEC 62366: 2007	IEC 62366: 2007
	ISO 149713

page 15 of 29

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Image /page/18/Picture/0 description: The image shows the logo for ACTEON. The logo is in blue and green, with the word "ACTEON" in large, bold letters. Above the word "ACTEON" is the text "de Götzen" in a smaller, gray font. A green curved line is below the word "ACTEON".

510 (k) submission Section 5

510 (k) Summary

Of October 3rd,
Ed. 3.0

page 16 of 29

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Image /page/19/Picture/0 description: The image shows the logo for ACTEON. The logo is in blue and green, with the word "ACTEON" in large, bold letters. Above the word "ACTEON" are the words "de Gotzen" in a smaller, gray font. A green swoosh appears to underline the left side of the word "ACTEON".

510 (k) submission Section 5 Ed. 3.0

510 (k) Summary

Of October 3rd,

page 17 of 29

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Image /page/20/Picture/0 description: The image shows the logo for ACTEON. The word "ACTEON" is written in large, blue, sans-serif font. Above the word "ACTEON" is the phrase "de Götzen" in a smaller, gray font. A green curved line is below the word "ACTEON".

510 (k) submission Section 5 Of October 3rd,
Ed. 3.0

510 (k) Summary

page 18 of 29

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Image /page/21/Picture/0 description: The image contains the logo for ACTEON. The logo is in blue and green. The word "ACTEON" is in large, bold, blue letters, and there is a green swoosh underneath the word. Above the word "ACTEON" is the text "de Gotzen" in gray.

510 (k) submission Section 5 Ed. 3.0

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

Of October 3rd, 2016

1 The dimension in pixel of the hyperion PAN image (1528px X 2797px) clearly indicates that hyperion is using only the lower resolution (Actual in imaging 96um pixel), being the standard size of a panoramic around 150mm X 280mm

2 Resolution data are taken from results of bench test performed on both devices.

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the logo for Acteon. The logo is in blue and green, with the word "ACTEON" in large, bold letters. Above the word "ACTEON" is the text "de Götzen" in a smaller font. A green swoosh appears to the left of the word "ACTEON".

510 (k) submission Section 5 Of October 3rd,
Ed. 3.0

510 (k) Summary

page 20 of 29

{23}------------------------------------------------

de Götzen ACTEON Via Roma, 45 21057 Olgiate Olona (VA)	X-MIND trium510 (k) Summary	510 (k) submissionSection 5Ed. 3.0 Of October 3 rd , 2016
-------------------------------------------------------------------------------------------------------------------	-----------------------------------------------	------------------------------------------------------------------------------

Table 1 - Comparison between proposed and predicate devices.

Both X-MIND trium and Hyperion X9 are digital panoramic, cephalometric and tomographic extra-oral X-ray systems. For analysis of patients' images, X-MIND trium can be provided with a dedicated workstation which has the following modules installed:

• ACTEON IMAGING SUITE (AIS) + 2D diagnostic analysis .
• AIS 3D app (for CBCT dataset only) ●

The 2D diagnostic analysis and the AIS 3D app (CBCT) provide a complete set of tools for visualization and post-processing of 2D radiographs (such as Panoramic, Cephalometric and Carpus radiographs) and 3D CBCT datasets.

AIS 3D app also includes special features for computer aided dental implant planning.

In like manner, the predicated device Hyperion X9 comes with the software NNT allowing the operator to perform scans, execute primary/volumetric/secondary 3D image reconstructions, view the 3D dataset and create diagnostic structured report.

X-MIND trium software is described in detail in Section 16.2 of this submission. The following summary table shows a comparison of the functionalities for image processing, enhancing and visualization implemented in:

• 1. the 2D diagnostic analysis + AIS 3DApp
• 2. NNT

This comparison is to provide evidence of substantial equivalence between the tools and means made available by both software module.

Software characteristic	X-MIND trium2D analysis + AIS 3Dapp	Hyperion X9NNT
Supported Image format	DICOM, JPEG, BMP, TIFF,GIFF, PNG, DGI(proprietary format)	DICOM, JPEG, BMP

3 Compliance to this Standard was evaluated with reference to IEC 60601-1 310 edition.

{24}------------------------------------------------

Image /page/24/Picture/0 description: The image features the logo for "de Götzen ACTEON". The word "ACTEON" is in large, bold, blue letters. Above it, in smaller gray letters, is "de Götzen". A green curved line underlines the left side of the word "ACTEON", adding a visual element to the logo.

510 (k) submission Section 5

510 (k) Summary

Of October 3rd, Ed. 3.0 2016

Functionalities and features for 2D images:single 3D tomographic sections, panoramic and cephalometric radiographs
Basic image visualizationfeatures	+ Zoom and pan+ Rotation+ Flipping / mirroring,vertical / horizontal	+ Zoom and sort+ Rotation
Measuring function	+ Measuring distances+ Measuring angles+ Adding annotation+ Viewing Pixel profile	+ Measuring distances+ Measuring angles+ Adding annotation+ Viewing Pixel profile+ Add marker+ Add lines
Visualization filters	+ Gamma filter+ Sharp filter+ Equalize filter+ Emboss filter+ Reverse filter	+ Gamma filter+ Sharp filter+ Reverse filter+ BEnh (bone enhancer)+ STS (smooth soft tis.)
Pseudocolour analysis LUTs	+ Gray+ Inverse Spectrum	+ Gray+ Spectrum+ Sepia+ Blue+ Film+ Red+ Flame
Windowing	+ Contrast-brightnessset+ Lower-Upper level+ SHS optimalwindowing	+ Contrast-brightnessset+ Lower-Upper level
Reporting	Included	Included
Functionalities and features for CBCT 3D dataset
Basic image visualizationfeatures	+ Zoom and pan+ Rotation+ Flipping / mirroring,vertical / horizontal	+ Zoom and sort+ Rotation
Measuring function	+ Measuring distances+ Measuring angles	+ Measuring distances+ Measuring angles

page 22 of 29

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	X-MIND trium			510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary		Ed. 3.0	Of October 3rd,2016
	+ Adding annotation+ Viewing Voxel profile		+ Adding annotation+ Viewing Voxel profile+ Add marker+ Add lines
	+ Measuring polygon+ Measuring volumes+ Measuring distance on3D		+ Measuring distance on3D
Processing filters	+ Sharp filter+ Median filter		+ Gamma filter+ Sharp filter
	+ SHARP filter: denoiserand edge enhancer+ STAR filter: streak andmetal artifacts reduction		+ Reverse filter+ BEnh (bone enhancer)+ STS (smooth soft tis.)
Multi Planar Reconstruction(MPR)	+ Axial plane+ Coronal plane+ Sagittal plane		+ Axial plane+ Coronal plane+ Sagittal plane
Oblique MPR	Included		Included
Single and multiple crosssections visualization	Included+ Setting number ofsections+ Setting distance ofsections		Included+ Setting number ofsections+ Setting distance ofsections
Windowing	+ Contrast-brightnessset+ Lower-Upper level+ Editing preset		+ Contrast-brightnessset+ Lower-Upper level
Display mode	+ MPR (voxel intensity)+ Ray Sum+ Maximum intensityprojection (MIP)+ Minimum intensityprojection (minMIP)+ SCOUT+ Volume thicknessselection (for MIP andRay Sum)		+ MPR (voxel intensity)+ Ray Cast+ Maximum intensityprojection (MIP)+ Volume thicknessselection (for MIP andRay Cast)
3D volume rendering	+ Preset template+ Editing of user-definedtemplate		+ Preset template+ Editing of user-definedtemplate
de GötzenACTEONVia Roma, 4521057 Olgiate Olona (VA)	X-MIND trium	510 (k) submissionSection 5
	510 (k) Summary	Ed. 3.0	Of October 3rd,2016
Surface Rendering	+ Surface generation+ STL export	+ Surface generation
Curve Planar Reformation (CPR)for dental analysis	+ Dentascan wizard	+ Panorex synthesis
Advanced 3D visualization tools	+ 3D clipping: 3D cut byorthogonal planes+ 3D thin slab rendering+ 3D sculpting: 3D cutby user-defined planes+ 3D flying mode: 3Dvirtual endoscopy	+ Crop function: 3D cutby orthogonal planes
Advanced 3D functions	+ Implant planningwizard+ Nerve tracing+ Importing 3D STLobject in patient volume+ STL implant library+ Measuring bonedensity at implant sites+ Bone/tissue removal
General purpose functionalities
Screenshot capture function	Image capture (AIS 3Dapp)2D analysis module(Export)	Screenshot command

page 23 of 29

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Table 2: comparison between Acteon Imaging Suite and predicate device software.

The above tables show that the two devices have the same intended use and equivalent performance specifications: they are both used to perform panoramic, cephalometric and CBCT analysis and they can be used to perform the same exams.

Both the proposed and the predicate device have the same type of power supply, similar nominal voltage (open range interval) and similar nominal current.

From the electrical classification point of view (IEC 60601-1) they are Class I type B, while the EMC classification (CISPR11) underlines a minor difference: Hyperion X9 is Group 1 - Class B (devices for usage in domestic establishments that are directly connected to a low voltage power supply network, which supplies domestic environment); X-MIND trium is Group 1 – Class A (devices for usage in all establishments other than domestic and that are not directly connected to a low voltage power supply network, which supplies domestic environment). For the intended use defined for X-MIND trium, this device has to be used only in clinics and dental surgeries or hospitals, not in domestic establishments. Therefore, the classification of the proposed device is equivalent to that of the predicate device.

{27}------------------------------------------------

de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0	Of October 3rd,2016

X-MIND trium and Hyperion X9 use the same X-ray tube to generate the radiation. The values of total filtration are not significantly different and they both comply with the requirements of the reference Standard (IEC 60601-1-3).

Mechanical characteristics of the proposed and predicate device are completely comparable.

General Tools and means made available by both software are equivalent.

From the comparison it is clear that the two devices have one significant difference: the technology of the panels used for panoramic and cephalometric exams. In fact, X-MIND trium uses the CMOS technology, while the predicate device Hyperion X9 uses the CCD technology.

For CBCT analysis, the two devices use the same type of detector (CMOS).

In order to verify the full equivalence of devices, we provided performance testing data as outlined in the FDA guidance document, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices," and also 3D imaging performance (Homogeneity, Contrast to Noise Ratio (CNR), High contrast resolution (MTF), Nyquist frequency, Artifacts, Voxel Noise Power Spectrum (NPS)) compared with radiation dose data.

VII. PERFORMANCE, SAFETY, EMC TESTS

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on X-MIND trium.

The performance tests on X-MIND trium have been conducted by a Nationally Recognized Testing Laboratory (NRTL) in order to verify:

• compliance with general requirements for basic safety and essential . performance of medical electrical equipment, dental intra-oral X-ray equipment, diagnostic X-ray equipment, programmable electrical medical systems, high-voltage generators of diagnostic X-ray generators, X-ray source assemblies and X-ray tube assemblies for medical diagnosis;
• compliance with usability requirements; .
• . compliance with electromagnetic compatibility requirements.

Table of applicable standards available in "Table 1 – Comparison between proposed and predicate devices". illustrates the standards to which X-MIND trium complies, compared to those related to Hyperion X9.

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0	Of October 3rd,2016

Both the devices comply with the same standards, but X-MIND trium is also compliant with IEC 60601-1 deviations for US and Canada.

For the proposed device X-MIND trium electrical, mechanical and environmental safety testing according to the standards IEC 60601-1: 2007, ANSI/AAMI ES60601-1: 2005, CAN/CSA C22.2 No. 60601-1:08, IEC 60601-1-3: 2008, IEC 60601-2-63: 2012, IEC 60601-1-6: 2010 and IEC 62366: 2007 were performed by Intertek Semko, which is a Nationally Recognized Testing Laboratory (NRTL). EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2007 by Nemko S.p.A., which is a Nationally Recognized Testing Laboratory (NRTL) for the EMC tests (Accredia n. 1244).

The third parties assessed conformance of the medical device with the FDArecognized standards and issued a final report for each of these standards.

All the test reports for X-MIND trium are available in Section 21 of this submission.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the content of premarket submissions for software contained in medical devices". The software for this device was considered a "moderate" level of concern, since a failure or latent flow could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Moreover General Tools and means made available by both software are equivalent.

Performance testing - Bench

The X-MIND trium is provided with three different flat panel detectors, each one intended for a specific mode of operation:

The bench tests were gathered according the mode of operation and the detector is use and they compared image quality and radiation dose according to the table below.

LIST OF BENCH TESTS
Test group	Test	Endpoints / metrics
Cephalometric	Image quality test	- Image homogeneity- Artifacts- Low contrast spatial resolution- High contrast spatial resolution
Cephalometric	Radiation dose test	- Dose area product (DAP)
Panoramic	Image quality test	- Image homogeneity

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0 Of October 3rd, 2016
3D CBCT	Radiation dose test	- Artifacts- Low contrast spatial resolution- High contrast spatial resolution- Dose area product (DAP)
	Image quality test	- Homogeneity- Contrast to Noise Ratio (CNR)- High contrast resolution (MTF)- Nyquist frequency- Artifacts- Voxel Noise- Noise Power Spectrum (NPS)
	Radiation dose test	- Dose area product (DAP)

Table 3: list of bench tests

The conclusion of bench tests are the following:

X-MIND trium equipped with the C10502D-42 has been judged to provide cephalometric test pattern images of equivalent quality to those by the Hyperion x9.

The declared dose of both devices are under the DRL for Dental lateral cephalogram adult (32 mGycm2) according to NCRP REPORT No. 172 (2016). Therefore we can assume that technological difference in CEPH detectors does not raise different concerns on safety and effectiveness for X-MIND trium as compared to the predicate device.

X-MIND trium equipped with the C10500D-42 has been judged to provide cephalometric test pattern images of equivalent quality to those by the Hyperion x9.

The declared dose of both devices are under the DRL for Dental panoramic (100 mGycm²) according to NCRP REPORT No. 172 (2016).

Therefore we can assume that technological difference in PAN detectors does not raise different concerns on safety and effectiveness for X-MIND trium as compared to the predicate device.

X-MIND trium equipped with the C12280D-40 used for CBCT scan has been judged to provide

for standard quality datasets a higher image quality with a slightly increased DAP for high quality protocols higher image quality performances with the same level of dose within the measurement uncertainty.

In order to support the claim of substantial equivalence we calculated a system index having as a reference standard DIN 6868-161

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Image /page/30/Picture/0 description: The image contains the logo for ACTEON. The logo is in blue and green. The text "de Gotzen" is above the ACTEON logo.

510 (k) submission Section 5 Of October 3rd, Ed. 3.0 2016

Via Roma, 45 21057 Olgiate Olona (VA)

510 (k) Summary

$$S_{DAP} = \frac{CNR}{DAP \cdot \left(\frac{1}{2 \cdot V_{50%}}\right)^2}$$

with the following results

Test group	Test type	Outcome
Cephalometric test group	Image quality	Substantial equivalence is confirmed by metrics
	Radiation dose	Both Hyperion andX-MIND trium are under the DRL suggested inthe NCRP Report No. 172
Panoramic test group	Image quality	Substantial equivalence is confirmed by metrics
	Radiation dose	Both Hyperion andX-MIND trium are under the DRL suggested inthe NCRP Report No. 172
CBCT test group: Standardquality protocols	Image quality
	Homogeneity	Homogeneity for Hyperion is 2.8-10.9 timeshigher that X-MIND trium
	CNR	CNR for Trium is $2.12 \div 2.37$ times higher thanthe CNR for Hyperion.
	MTF	the MTF plots show that Trium better maintainsthe high frequencies between 1.25 lp/mm and1.5 lp/mm.
	Nyquist freqency	equivalent
	Absence ofartifacts	equivalent
	Radiation dose	Hyperion is lowerbut the dose for X-MIND trium can be reducedby using other scan protocols
	System Indicator	Substantial equivalence is confirmed by SDAP
CBCT test group: High qualityprotocols	Image quality
	Noise	the voxel noise for Hyperion is 43.5% ÷ 53.8%higher than Trium.
	NPS	Noise content very similar at low frequencies,Hyperion shows a content of noise higher thattrium at medium and high frequency
	Radiation dose	Substantial equivalence is confirmed by metrics

Furthermore, since the three detectors implemented in X-MIND trium haven't been cleared by FDA, the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" has been followed, in order to provide performance testing data for all the three detectors. Data are contained in section 18 Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices

and in section 18.3:X-MIND trium vs Hyperion X9 Clinical Considerations that constitutes an annex to previous section.

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de GötzenACTEON	X-MIND trium	510 (k) submissionSection 5
Via Roma, 4521057 Olgiate Olona (VA)	510 (k) Summary	Ed. 3.0 Of October 3rd, 2016

VIII. CONCLUSIONS

Based on:

• . comparison of parameters included in comparison table for devices and related softwares,
• results of bench test,
• . results of application of Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices including comparison of clinical images obtained with X-MIND trium and predicate device;

we can state that X-MIND trium system is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.