Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital X-ray system with image processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on hardware changes, dose reduction features, and image quality metrics.

Therapeutic

No
The device is an X-ray system used for diagnostic imaging, not for direct therapy. Its purpose is to produce images for diagnosis, not to treat a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in: producing panoramic X-ray images for diagnostic examination (teeth), jaws and oral structures" and "producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones". This directly indicates its use for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system consists of both a scanner (hardware components like X-ray generator, detectors, etc.) and a workstation running software. It is an extra-oral X-ray system, which is inherently a hardware device with accompanying software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The X-MIND trium is an extra-oral X-ray system. It produces images of anatomical structures within the body using X-rays. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states the device is for producing X-ray images for diagnostic examination of teeth, jaws, oral structures, maxillofacial region, skull, hands, and wrists. This is imaging, not in vitro analysis.
Device Description: The description details the components of an X-ray system, including an X-ray generator, detectors, and software for image display and analysis. There is no mention of components or processes related to analyzing biological specimens.
Anatomical Site: The anatomical sites listed are all parts of the human body being imaged directly, not sources of specimens for analysis.

Therefore, the X-MIND trium falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (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

Product codes

OAS, MUH

Device Description

The X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. It consists of a scanner and an operator's workstation. The scanner includes an X-ray generator, a U-arm that rotates around the patient, a sliding body, and a detector sliding group that contains image detectors. It can be configured with a PAN only cassette, a Standard PAN/CBCT Cassette, or a TRUE LOW DOSE (TLD) cassette, which allows for both PAN and CBCT exams with a single image detector. The system supports various examination modes including panoramic (standard, child special SID), TMJ, bitewing, sectorial, maxillary sinuses, CBCT (full view, extended view, stitched, child special SID), and cephalometric (frontal, lateral, hand acquisition). The workstation
, which can be supplied by de Götzen, allows control over device calibrations, acquisition parameters setting, image acquisition, image visualization and post-processing, and database management. The system also includes an X-MIND trium Remote Control for activating X-ray emission and an X-MIND trium Light indicator. The device can be installed as wall-mounted or self-standing. The TLD version introduces a new movement for the cassette to modify the Source to Image Distance (SID), allowing for reduced SID for special child exams, and includes a Low Dose functionality for CBCT exams which uses approximately half the anodic current of Standard Dose protocols while maintaining diagnostic image quality.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Dentition (teeth), jaws, oral structures, maxillofacial region, parts of the skull, cranial bones, hands, wrists (carpus).

Indicated Patient Age Range

Adults and pediatric patients from 5 years old.

Intended User / Care Setting

Surgeons, dentists and authorized physicians. Care setting implicit in use for dentistry and surgery.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A clinical detectability analysis was performed by submitting radiographs of cadavers to a set of intended users (radiologist, dentist, oral surgeon) who evaluated the visibility of anatomical structures and features of interest in different scanning conditions (Standard Dose protocol and TLD protocol). The results indicated that the overall diagnostic quality of CBCT datasets and dental panoramic images obtained with the TLD functionality is basically the same as images from standard scan protocols.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing included electrical safety and electromagnetic compatibility (EMC) tests, and bench testing.
Bench testing evaluated the trade-off between image quality and radiation dose for images obtained with dose reduction due to the TLD cassette (for special child exams) and the Low Dose functionality (CBCT mode only).
Key results from quantitative bench testing for the New PAN-CBCT detector and TLD cassette, comparing to predicate:

System Indicator (SI) in CBCT (S_DAP): S_DAP TLD >= S_DAP predicate for Woman (Medium Standard quality, FOV 80X80-80X90, 110X80) and Child (Medium Standard quality, FOV 80X80-80X90, SID Adult/Child). All results indicate "PASS".
Voxel Noise [a.u.] (VNTLD) with TLD cassette = 2.5 ("k >> 2.5") for local collapse, Safety factor >= 4 (" >4 with respect to yielding (local plastic strains), >4 with respect to local collapse"). No overbalance at 10° in all directions. All "PASS".
Usability verification: All comments are positive. "PASS".
Child special exam tool (biocompatibility): Cytotoxicity: No cytotoxic ("PASS"); Hypersensitivity: Not sensitizing ("PASS").

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

S_DAP: S_DAP = CNR / (DAP * (1 / (2 * V50%))^2)
VNTLD (Voxel Noise)
NPS0D (Noise Power Spectrum)
CNR (Contrast to Noise Ratio)
DAP (Dose Area Product)
V50% (Resolution indicator at 50% modulation)
High contrast resolution (lp/mm)
Low contrast resolution (number of holes visible)
Delta %VN = (VNld - VNs) / (100 + VNsd)

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.

Summary

0

February 20, 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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines.

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

Re: K191719

Trade/Device Name: X-MIND Trium Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: January 10, 2020 Received: January 22, 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

1

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

2

Indications for Use

510(k) Number (if known) K191719

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 (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

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 X-ray exposure must be evaluated by surgeons, dentists and authorized physicians.

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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| ACTEON
Via Roma, 45
21057 Olgiate Olona (VA) | X-MIND trium
510(k) Summary | VOL. 005
002_k Summary |
|----------------------------------------------------|--------------------------------|---------------------------|
| | | K191719 |

Index

	510 (k) Summary	2
I.	SUBMITTER	2
II.	DEVICE	2
III.	PREDICATE DEVICE	3
IV.	DEVICE OVERVIEW	3
V.	MAIN CHANGES TO THE PREVIOUS CLEARED DEVICE ARE	4
VI.	OVERVIEW OF THE SYSTEM	8
VII.	OVERVIEW OF THE SCANNER	10
VIII.	EQUIPMENT CONFIGURATIONS	13
IX.	EXAMS	15
X.	Setup configuration	15
	Wall mounted	15
	Self-standing	17
XI.	ACCESSORIES	18
XIII.	COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE	21
XIV.	PERFORMANCE, SAFETY, EMC TESTS	55
XV.	CONCLUSIONS	57

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Image /page/4/Picture/0 description: The image shows the logo for ACTEON. The logo consists of the word "ACTEON" in bold, sans-serif font. A blue swoosh appears to the left of the word, adding a dynamic element to the design. The overall impression is modern and professional.

Via Roma, 45

X-MIND trium

VOL. 005

K191719

510 (k) Summary

21057 Olgiate Olona (VA)

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

l. 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
Dario Bandiera	dario.bandiera@acteongroup.com
Alvise Reither	alvise.reither@acteongroup.com
Date:	10/01/2020

Table 1: Submitter information

II. DEVICE

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

Table 2: device

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Image /page/5/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 swoosh design is located to the left of the word. The swoosh starts thin and curves upward, becoming thicker as it moves towards the letter "A".

VOL. 005

Summary

002_k Summary

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

III. PREDICATE DEVICE

Legally marketed device to which equivalence is claimed is:

PREDICATE DEVICE
Device name	X-MIND trium
Manufacturer	de Götzen S.r.l. - ACTEON Group
Device product code	OAS
Subsequent product code	MUH
Regulation number	892.1750
Regulation name	Computed tomography x-ray system
Clearance date	November 15, 2016
510(k) number	K160166

Table 3: Predicate device information

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

No reference devices were used in this submission.

IV. DEVICE OVERVIEW

The modified X-MIND trium has the same indication for use of X-MIND trium (as identified in the labelling) and it is based on the same fundamental scientific technology.

It 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 reqion 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

| Rev. n. 2
10/01/2020 | X-MIND trium 510 (k) | VOL. 005
Page 3 of 58 |

-------------------------	----------------------	--------------------------

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Image /page/6/Picture/0 description: The image shows the logo for ACTEON. The logo features the company name in bold, sans-serif font, with the letters slightly slanted to the right. A curved, blue graphic element is positioned to the left of the word "ACTEON", adding a visual accent to the logo.

VOL. 005

· Dental surgery
Via Roma, 45
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 X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

V. MAIN CHANGES TO THE PREVIOUS CLEARED DEVICE ARE

Main changes to the previous cleared device are addition of a new accessory: new sliding cassette called X-MIND trium TLD cassette including a new model of CBCT sensor (C12903D-40 - Hamamatsu) that can be used for both panoramic and CBCT examination; introduction, as alternative components, of CEPH and PAN sensors with wider admitted range of power supply value: (from 4.9 – 5.1 VDC to 8 – 12 VDC).

Since CBCT and PAN sensor usually operates on a different SID (Source to Image Distance), a new movement of the cassette has been added, to give to the device the possibility to modify the SID.

The possibility to configure the SID allows also the possibility to perform special exam for child: reduced SID distance that means possible reduction of x-ray dose to the patient.

Image /page/6/Figure/15 description: The image shows a diagram of the X-MIND trium rotating arm with different sliding cassette configurations. The top row shows the original sliding cassette being cleared from the X-MIND trium rotating arm. The bottom row shows a new TLD sliding cassette being added to the X-MIND trium rotating arm. The diagram illustrates the process of upgrading or modifying the X-MIND trium rotating arm with different sliding cassette options.

Figure 1 addition of TLD Sliding cassette

The lateral movement of the cassette is obtained with the same motor used in the cleared version of X-MIND trium.

For the movement we use a new linear quide with ball bearing runners.

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	X-MIND trium	VOL. 005
		002_k Summary
Via Roma, 45	510(k) Summary
21057 Olgiate Olona (VA)

The SID movements uses the same motor as the one installed in the handle rest area of the patient (satellite group), and two linear guides with ball bearing runners as the cleared version of TRIUM

The cassette is made of a steel plate with the new CBCT sensor and relevant shielding lead on the back.

Image /page/7/Picture/3 description: The image shows a close-up of a mechanical device with various components. There is a large square orange component with the numbers 121.2 and 140 on it. The device also has green, purple, and tan components, as well as several screws and bolts. The device appears to be a part of a larger machine or system.

Figure 2: new TLD cassette scheme

The new CBCT sensor has nominal dimensions of 15x12 cm, while the sensor used in cleared version of X-MIND trium is 12x12.

The 15 cm height is required to allow panoramic examinations.

The new sensor C12903D-40 has 8V power supply input while the previous was 5V. Similarly, the new SID movements require a related driver. For that reason, a new AUXCBCT board has been designed with code: PE5541_AUXCBCTPLUS.

The overall insulation diagram of the whole device has not changed in respect of the cleared X-MIND trium, apart from the absence of the contacts for PAN and CEPH sensors that aren't anymore detachable (improvement)

The relevant insulation of the board PE5541 AUXCBCTPLUS A01 is the same as the PE4016_AUXCBCT_A04, already installed (and certified) on the V1 version of the TRIUM.

Due to the possibility to reduce the SID, special exams for child has been introduced and at the same time we have developed countermeasures to avoid that an adult is positioned during a special child exam.

The new workflow on the software introduces a new step: the doctor uses a tool provided with the machine to check if the user fits the proper dimension for the examination with the reduced SID.

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		X-MIND trium	VOL. 005
Via Roma, 45	510(k) Summary	002_k Summary
21057 Olgiate Olona (VA)

Figure 3: use of head measurement tool

DON'T

FIT

X-MIND trium and the X-MIND trium TLD are provided with a new functionality, the Low Dose functionality.

The Low Dose functionality allows the user to perform the CBCT exams by using the Low Dose protocols for all kind of patients (MAN, WOMAN and CHILD) as an alternative of the Standard Dose protocols.

FIT

The selection of a Low Dose protocol is performed in the AIS interface during the specification of the exam settings (see Figure 4).

A Low Dose protocol applies at least the half of the anodic current than the corresponding Standard Dose protocol, so ensuring a radiation dose saving for the patient of about 50% (refer to the declared DAP in the AIS interface, Figure 5); the image quality by the Low Dose protocols ensures the same diagnostic value as the corresponding Standard Dose protocols (Basing on the bench test results on image quality and radiation dose obtained).

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| ACTEON
Via Roma, 45
21057 Olgiate Olona (VA) | X-MIND trium
510(k) Summary | VOL. 005
002_k Summary |

----------------------------------------------------	--------------------------------	---------------------------

Image /page/9/Picture/1 description: The image shows a graphical user interface (GUI) with various options and settings, likely for a medical imaging device. The GUI includes options for selecting patient size (Man, Woman, Child, Small, Medium, Large), field of view (Dental FOV, ENT FOV - Nose, ENT FOV - Ear), image size (40x40, 60x60, 80x80, 110x90), and image quality (Standard, Medium, High). There are also options for dose (Standard dose, Low dose) and additional settings such as Show Warnings, Select Filters, Select Focus Point, Scout, and Fill Dental Chart, all of which appear to be toggled 'ON'.

Figure 4 - AIS interface for the definition of the Low Dose protocol

	Standard	Low Dose
Current (mA)	8	4
Voltage (kV)	90	45
Current Time Product (mAs)	55.9	27.9
DAP (mGycm²)	902.7	451.35

Figure 5 - Acquisition parameters and dose declaration between Standard Dose and Low Dose protocols

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ACTEON	VOL. 005
Via Roma, 45	002_k Summary
21057 Olgiate Olona (VA)

X-MIND trium
510(k) Summary

VI. OVERVIEW OF THE SYSTEM

Image /page/10/Figure/2 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 radiation warning device labeled as '2', and a power supply labeled as '3'. The dental X-ray machine is labeled as '4' and is connected to all three devices via lines. The diagram illustrates the setup and connections required for the dental X-ray machine to function properly.

Figure 6: overview of the system

| Part 1 | - 1 Gb, 8-wire Ethernet cable cat. 6>250mhz, 27 AWG, 10 m long

Operator's Workstation |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Part 2
Image: Radioactivity symbol and remote control | - Control cable, 10 wires, 5 twisted pairs 10 m long aluminium
shielded
X-MIND trium Remote Control
X-MIND trium Light |
| Part 3
Image: Terminal block | - Power cord, 3G1,5 AWG 16, 300 / 500 V, 10 m long
-Connection to the mains by means of clamps and screws
(Equipment installed permanently in compliance with IEC 60601-

|

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Image /page/11/Picture/0 description: The image shows the logo for ACTEON. The logo is in black font and has a blue swoosh underneath it. The logo is simple and modern.

VOL. 005

002_k Summary

510(k) Summary

Via Roma, 45 21057 Olgiate Olona (VA)

Image /page/11/Picture/5 description: The image is split into two parts. The left side of the image contains the text "Part 4". The right side of the image shows a close-up of electrical components, including wires and connectors. The components are various colors, including white, black, yellow, and blue.

X-MIND trium main connector consisting of 3 modules Communication, control and power supply
Moving part of the X-MIND trium connector
Fixed part of the X-MIND trium connector

Table 4: details of the system

The system consists of:

. X-MIND trium SCANNER
. OPERATOR'S WORKSTATION

The operator can control all aspects of the medical device by means of the workstation that can be supplied by de Götzen.

The workstation must have installed with the following modules:

. AIS equipment management software + AIS 2DApp diagnostic analysis
. AIS 3DApp dataset display software CBCT

Communication with the medical device occurs by means of a sturdy and reliable Ethernet protocol.

The workstation allows the operator to perform the following procedures:

Calibrations of the medical device -
Acquisition parameters setting -
-Getting an acquisition
Image visualization and post processing -
-Database management
Periodic quality Tests -
X-MIND trium REMOTE CONTROL .

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

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	X-MIND trium	VOL. 005
ACTEON		002_k Summary
Via Roma, 45	510(k) Summary
21057 Olgiate Olona (VA)

The X-MIND trium Light is an indicator light that warns that X-ray emission is in progress.

VII. OVERVIEW OF THE SCANNER

Image /page/12/Figure/3 description: The image shows a dental X-ray machine with several parts labeled with numbers. The numbers range from 1 to 10, each pointing to a specific component of the machine. The image also includes a close-up view of a section of the machine, with parts labeled 5, 6, and 7.

Figure 7: overview of the scanner

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VOL. 005

002_k Summary

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

The X-MIND trium scanner consists of the following parts:

| 1 | Control panel | The control panel provides an intuitive overview of the system to
move the mobile column, turn the positioning lasers on and off
and activate the X-MIND trium medical device. |
|---|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | X-ray generator | The X-ray assembly is the source of the X-ray beam during the
rotation of the U-Arm. The pulsed beam is modelled by an
automatic collimator, whereas the electronic control ensures
stability and accuracy of the selected loading factors (exposure
time, kVp and anodic current). An aluminium filter is used to
harden the beam and remove low-energy ionising radiations,
thereby obtaining suitable radiation quality whilst reducing its
dose absorbed by the patient. |
| 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 Detector sliding group and the X-ray
generator. This is the rotating part of the medical device, which
moves around the patient during the image acquisition phase. |
| 5 | Detector sliding
group | It contains detectors that allow acquire images. This cassette can
be provided in the following versions:
PAN Only cassette; Standard PAN/ CBCT Cassette; TRUE LOW DOSE cassette that permit to perform both PAN
and CBCT exams. (* only with X-MIND trium TLD version) |
| 6 | CBCT detector | This flat panel detector is indicated for use in generating
radiographic images of the maxillo-facial region, more specifically
it is dedicated for CBCT acquisitions.
in X-MIND trium TLD version there is only one image detector, for
PAN and CBCT exam; the equipment automatically exposes in
front of X-Ray source the right portion of detector, depending on
the selected exam; |
| 7 | PAN detector | This flat panel detector is indicated for use in generating
radiographic images of the maxillo-facial region, more specifically
it is dedicated for PAN acquisitions. |

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|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Via Roma, 45
21057 Olgiate Olona (VA) | | |
| | * in X-MIND trium TLD version there is only one image detector,
for PAN and CBCT exam; the equipment automatically exposes in
front of X-Ray source the right portion of detector, depending on
the selected exam; | |
| 7 | TLD CASSETTE* | * only for X-MIND trium TLD version
Sliding cassette that lets to activate true low dose exams.
Some models of X-MIND trium can be upgraded in the field to TLD
cassette configuration. |
| 8 | Patient support | The patient support allows stabilising and immobilising the
patient. It is equipped with instruments to move the patient's
head in all directions and find the best superimposition between
the patient's anatomy and the 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 and lowers the mobile
column, the main control panel of the system and the main switch.
In the wall installation version, the fixed column is equipped with
an anchor plate; in the free-standing version, on the other hand,
the medical device is equipped with a footrest.
CEPH arm extension (not represented in Overview of the medical
device) |

The ceph arm extension can be positioned both on the right or left side of the vertical column, with the patient positioning aiming device (ear and nasion rest) for CEPH exams;

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the CEPH secondary collimator, translating during X Rays (to stay aligned with the X-Ray beam emerging from the tubehead on overhead carriage);

the CEPH image detector, translating during X Rays (to stay aligned with the X-Ray beam emerging from the secondary collimator on the CEPH arm itself)

VIII. EQUIPMENT CONFIGURATIONS

X-MIND trium equipment can be sold in these different configurations:

PAN only

the equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus); the image detector is not movable from PAN bay;

all the exams are carried out with the same extension in height on image receptor), primary collimator beinq of fixed dimension;

the equipment can be upgraded in the field to more advanced configurations

PAN / CBCT

the equipment can carry out uniquely 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;

the PAN exams can be carried out with different extension in height (up to 146mm height on imaqe receptor), primary collimator being automatically adjusted in height, dependinq on exam selected by the user:

the CBCT exams can be carried out at different FOV dimensions;

the equipment can be upgraded in the field to PAN/CEPH/CBCT configuration by simple procedure, adding CEPH arm with CEPH image detector replacing the existing PAN image detector; the equipment has a touch screen panel as main user interface;

PAN / CEPH

the equipment can carry out uniquely exams of the PAN group (PAN, TMJ, Sinus) and of the CEPH group (AP/PA, LL, carpus);

the image detector is unique, both for PAN and CEPH exams, and must be manually moved from PAN bay to CEPH bay and viceversa, depending on the selected exam;

the exams can be carried out with different extension in height (up to 146mm height on image receptor for PAN, up to 220mm height on image receptor for CEPH), primary collimator being automatically adjusted in height depending on exam selected by the user;

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the equipment can be upgraded in the field to PAN/CBCT/CEPH configuration by simple procedure, adding CBCT image detector and bite block holder with vertical movement;

the equipment mounts PAN detector sliding unity.

PAN / CBCT / CEPH (PAN Full)

the equipment can carry out all feasible exams of the PAN group (PAN, TMI, Sinus), of the CEPH group (AP/PA, LL, carpus) and of the CBCT group;

there are two image detectors, one for PAN/CEPH and one for CBCT exam; to carry out PAN or CEPH exam the PAN/CEPH image detector must be manually moved from PAN bay to CEPH bay and viceversa;

to carry out PAN or CBCT exam the equipment automatically exposes in front of X-Ray source the right detector, depending on the selected exam;

the PAN and CEPH exams can be carried out with different extension in height (up to 146mm height on image receptor for PAN, up to 220mm height on image receptor for CEPH), primary collimator being automatically adjusted in height depending on exam selected by the user;

the CBCT exams can be carried at different FOV dimensions;

the equipment has a touch screen panel as main user interface;

PAN / CBCT TLD version

The equipment can carry out both exams of the PAN group (PAN, TMJ, Sinus) and of the CBCT group; There is only one image detector, for PAN and CBCT exam; the equipment automatically exposes in front of X-Ray source the right portion of 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;

The equipment can be upgraded in the field to CEPH configuration by simple procedure, adding CEPH arm with CEPH image detector.

PAN / CBCT / CEPH TLD version

The equipment can carry out all feasible exams of the PAN group (PAN, TMJ, Sinus), of the CEPH group (AP/PA, LL, carpus) and of the CBCT group;

To carry out PAN or CEPH or CBCT exam 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;

the image detector is not movable from CEPH bay;

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IX. EXAMS

In its different configurations X-MIND trium equipment carries out the following exams (also said projections):

PAN group

Standard panorama -
Child special SID panorama (only with TLD cassette) -
TMJ .
Bitewing -
Sectorial -
Maxillary sinuses -

CBCT type

Full view -
Extended view (TBC) ।
Stitched (TBC) -
Child special SID CBCT (only with TLD cassette) -

CEPHALOGRAPHIC type

Frontal -
Lateral -
- Child lateral (reduced height and width) (non c'è nel manuale) o
- Complete lateral (non c'è nel manuale) O
-Hand acquisition (special support needed)

Setup configuration X.

Wall mounted

For this type of installation, the column is provided with two dedicated plates to fasten the equipment to the wall.

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| ACTEON
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21057 Olgiate Olona (VA) | X-MIND trium
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----------------------------------------------------	--------------------------------	---------------------------

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ACTEON Logo

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Self-standing

The self-standing accessory allows to install X-MIND trium without structurally fix it to the wall; the self-standing alone is designed to give full structural support to X-MIND trium for installation where the walls do not guarantee such support.

Although self-standing is sufficient to provide alone the needed structural support to X-MIND trium, it is anyway highly recommended to fix the X-MIND trium also to the wall, to reduce as much as possible the vibrations during the exams; this wall fixation has not safety implications, so it is responsibility of the customer to use it or not.

Image /page/19/Picture/9 description: The image shows a gray metal plate with a red rectangular inset. The plate has a Y-shape on both ends, with holes at the end of each arm of the Y. The red inset has several smaller holes and a rectangular cutout in the center.

Figure 9: wall mounted base

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XI. ACCESSORIES

Via Roma, 45

XMT SELF STANDING BASE (FWT)	Image: XMT SELF STANDING BASE (FWT)
XMT REMOTE BUTTON	Image: XMT REMOTE BUTTON
EXTERNAL LIGHT 100 - 240 V	Image: EXTERNAL LIGHT 100 - 240 V
XMT CARPUS SUPPORT	Image: XMT CARPUS SUPPORT
XMt UPG CEPH	Image: XMt UPG CEPH
XMt UPG 3D	Image: XMt UPG 3D
XMt TRUE LOW DOSE CASSETTE	Image: XMt TRUE LOW DOSE CASSETTE

Table 6: accessories

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ACTEON
Via Roma, 45
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X-MIND trium	VOL. 005
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XII. CONFIGURATIONS

Image /page/21/Picture/2 description: The image shows four different X-MIND trium Pan dental imaging systems and their features. The first system, "X-MIND trium Pan", has the "Pan" feature. The second system, "X-MIND trium Pan 3D", has both the "Pan" and "3D" features. The third system, "X-MIND trium Pan Ceph", has the "Pan" and "Ceph" features, and the fourth system, "X-MIND trium Pan Ceph 3D", has the "Pan", "3D", and "Ceph" features.

O`upgadable on site

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Image /page/22/Picture/1 description: The image shows two dental X-ray machines, labeled "X-MIND trium TLD Pan 3D" and "X-MIND trium TLD Pan Ceph 3D". A table below the machines indicates the availability of different scan types for each machine. The "X-MIND trium TLD Pan 3D" machine offers Pan and 3D scans, while the "X-MIND trium TLD Pan Ceph 3D" machine offers Pan, 3D, and Ceph scans.

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XIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Characteristic | Predicate | Proposed | Change
Id |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| Manufacturer | de Götzen S.r.l. – Acteon Group | de Götzen S.r.l. – Acteon Group | same |
| | Via Roma, 45 | Via Roma, 45 | |
| | 21057 Olgiate Olona | 21057 Olgiate Olona | |
| | VA - Italia | VA - Italia | |
| 510 (k) number | K160166 | | |
| Indication for 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; | 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; | same |
| | | | |

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| Characteristic | Predicate | Proposed | Change
Id |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| | - 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. | - 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. | |
| Performance
specifications | 1) Panoramic | 1) Panoramic | same |
| | 2) Cephalometric (optional) | 2) Cephalometric (optional) | |
| | 3) CBCT (optional) | 3) CBCT (optional) | |
| | 1) PAN: | 1) PAN: | same |
| | - standard panoramic | - standard panoramic | |
| | - child panoramic | - child panoramic | |
| | - TMJ | - TMJ | |
| Exam mode | - bitewing | - bitewing | |
| | - sectorial panoramic with
improved orthogonality | - sectorial panoramic with
improved orthogonality | |
| | - maxillary sinuses | - maxillary sinuses | |
| | 2) CEPH: | 2) CEPH: | |
| | - frontal (AP/PA) | - frontal (AP/PA) | |
| | - lateral (LL) | - lateral (LL) | |
| | - hand acquisition – carpus
(special support needed) | - hand acquisition – carpus
(special support needed) | |

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Summary

| Characteristic | Predicate | Proposed | Change
Id |
|-----------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| | 3) CBCT:

full view
extended view | 3) CBCT:
full view
extended view | |
| Type of power
supply | Single-phase alternating
current power supply | Single-phase alternating
current power supply | same |
| Nominal voltage | 100 V - 240V | 100 V - 240V | same |
| Maximum voltage
variation | ±10% | ±10% | same |
| Nominal current | 7 A (@ 240 V)
15 A (@ 100 V) | 7 A (@ 240 V)
15 A (@ 100 V) | same |
| Frequency | 50 - 60 Hz | 50 - 60 Hz | same |
| Operation mode | Continuous operation with
intermittent X-ray loading | Continuous operation with
intermittent X-ray loading | same |
| Protection against
electrical shock | Class I | Class I | same |
| Degree of
protection against
electrical shock | Type B | Type B | same |
| Emission | Group 1, Class A | Group 1, Class A | same |
| Manufacturer of
the X-ray tube | Skan X | Skan X | same |
| X-ray tube model | CEI OPX/105 | CEI OPX/105 | same |
| Nominal High
Voltage | 60 - 85 kV for PAN/CEPH | 60 - 85 kV for PAN/CEPH | same |

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Image /page/26/Picture/0 description: The image shows the word "ACTEON" in bold, black letters. A blue swoosh design is on the left side of the word. The swoosh starts below the "A" and curves upward and to the right, ending near the top of the "C".

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| Characteristic | Predicate | Proposed | Change
Id |
|--------------------------------|------------------------------------|------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| | 80 - 90 kV for CBCT | 80 - 90 kV for CBCT | |
| Anode heat
storage capacity | 30 kJ | 30 kJ | same |
| Nominal focal spot
diameter | 0.5 mm | 0.5 mm | same |
| Anode material | Tungsten | Tungsten | same |
| Target Angle | 5° | 5° | same |
| Anodic current | 4 – 10 mA for PAN/CEPH | 4 – 10 mA for PAN/CEPH | same |
| | 4 – 10 mA for CBCT | 4 – 10 mA for CBCT | |
| Total filtration | 2.8 mm Al for PAN/CEPH at 85
kV | 2.8 mm Al for PAN/CEPH at 85
kV | same |
| | 7.0 mm Al for CBCT at 90 kV | 7.0 mm Al for CBCT at 90 kV | |
| HVL | 3.4 mm Al for PAN/CEPH at 85
kV | 3.4 mm Al for PAN/CEPH at 85
kV | same |
| | 5.2 mm Al for CBCT at 90 kV | 5.2 mm Al for CBCT at 90 kV | |
| High Voltage | kV ± 10% | kV ± 10% | same |
| Current in the tube | mA ± 20% | mA ± 20% | same |
| Exposure time
seconds | Seconds ± (5% + 50ms) | Seconds ± (5% + 50ms) | same |
| Detector
technology | CMOS | CMOS | same |
| Detector
manufacturer | Hamamatsu | Hamamatsu | same |

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| Characteristic | Predicate | Proposed | Change
Id |
|----------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| | PAN: C10500D-42 | PAN: C10500D-70 | 1 |
| Detector model | CBCT: C12280D-40 | PAN/CBCT: C12903D-40G (TLD) | 3 |
| | CEPH: C10502D-42 | CEPH: C10502D-70 | 2 |
| Pixel size | 100 μm | 100 μm | same |
| | | PAN: 1480 px x 2658 px | 1 |
| Typical image size | PAN: 1480 px x 2658 px
(C10500D-42) | (C10500D-70)
PAN: 1400 px x 2658 px | 3 |
| | CEPH: 2232 px x 2673 px
(C10502D-42) | (C12903D-40G)
CEPH: 2232 px x 2673 px
(C10502D-70) | 2 |
| | | PAN: 148 mm x 6 mm | 1 |
| Active area | PAN: 148 mm x 6 mm
(C10500D-42) | (C10500D-70)
PAN: 140 mm x 6 mm | 3 |
| | CBCT: 121.6 mm x 123.2 mm
(C12280D-40) | (C12903D-40G)
CBCT: 139.2 mm x 121.2 mm
(C12903D-40G) | 3 |
| | CEPH: 220 mm x 6 mm
(C10502D-42) | CEPH: 223,2 mm x 6 mm
(C10502D-70) | 2 |
| Theoretical detector | 4.5 lp/mm | 4.5 lp/mm | 1, 2 |
| Actual in imaging1 | 4.5 lp/mm | 4.5 lp/mm | 1, 2 |
| Image resolution2: | PAN: high contrast resolution:
3.1 lp/mm | PAN: high contrast resolution:
3.1 lp/mm | 1 |
| | PAN: low contrast resolution:
Four holes are visible | PAN: low contrast resolution:
Four holes are visible | 1 |

2 Resolution data are taken from results of bench test performed on both devices (See section 15 Bench tests)

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Predicate

510(k) Summary

Proposed

002_k Summary

Change

Characteristic	Predicate	Proposed	Change Id
	X-MIND trium	X-MIND trium
	CEPH: high contrast resolution:
3.1 lp/mm	CEPH: high contrast resolution:
3.1 lp/mm	2
	CEPH: low contrast resolution	CEPH: low contrast resolution	2
	Four holes are visible	Four holes are visible
X-ray exposure
time	PAN: 16.8 s	PAN: 16.8 s	1
	CEPH:18 s	CEPH:18 s	2
Detector
technology	Flat panel CMOS	Flat panel CMOS	same
Detector
manufacturer	Hamamatsu	Hamamatsu	same
Detector model	C12280D-40	C12903D-40G	3
Image voxel size	75 µm (minimum slice
thickness)	75 µm (minimum slice
thickness)	3
FOV
(diameter x height)	40 mm x 40 mm	40 mm x 40 mm	3, 4
		60 mm x 60 mm
	60 mm x 60 mm	80 mm x 80 mm
	80 mm x 80 mm	80 mm x 90 mm
	110 mm x 80 mm	110 mm x 80 mm
		110 mm x 90 mm
Detector
resolution²:	High contrast resolution: V10%:
2.07 lp/mm:	High contrast resolution: V10%:
2.81 lp/mm:	3
	High contrast resolution: V50%:
0.72 lp/mm	High contrast resolution: V50%:
0.95 lp/mm

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Change

| Characteristic | Predicate | Proposed | Change
Id |
|-------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| Rotation | 360° | 360° | same |
| Scanning time | 12 s to 30 s maximum | 12 s to 30 s maximum | same |
| X-ray real
exposure time | 6s (Normal quality)
7.2s (Medium quality)
9s (High quality) | 6s (Normal quality)
7.2s (Medium quality)
9s (High quality) | same |
| Source Image
Distance (SID) | PAN: 550mm
CBCT: 633mm | PAN: 550mm (adult)
PAN: 490mm (special small
child)
CBCT: 610 (adult)
CBCT: 588 (special small child) | 4 |
| Protocol types
(CBCT exams only) | Standard Dose protocols | Standard Dose protocols
Low Dose (LD) protocols | 7 |
| Dimensions | Footprint:
PAN/CBCT: max 1100 mm x
1505 mm
With CEPH: max 1715 mm x
1500 mm
Height: 2350 mm | Footprint:
PAN/CBCT: max 1100 mm x
1505 mm
With CEPH: max 1715 mm x
1500 mm
Height: 2350 mm | same |
| Weight | PAN: 230 kg
PAN/CBCT: 240 kg
PAN/CBCT With CEPH: 280 kg | Wall mount:
PAN: 230 kg
PAN/CBCT: 240 kg
PAN/CBCT With CEPH: 280 kg
Self standing:
PAN: kg 280 | 6 |

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| Characteristic | Predicate | Proposed | Change
Id |
|-----------------------------|----------------------------------------|----------------------------------------|--------------|
| | X-MIND trium | X-MIND trium | |
| | | PAN/CBCT: kg 290 | |
| | | PAN/CBCT With CEPH: kg 330 | |
| Mechanical
configuration | Wall mount | Wall mount | 6 |
| | | Self standing | |
| Patient position | Standing, seated or on wheel-
chair | Standing, seated or on wheel-
chair | same |

Table 7 Comparison between proposed and predicate devices.

Both X-MIND trium and X-MIND trium TLD 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 (clearance K173041)

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.

X-MIND trium TLD introduce a new SID movement (source to image distance) and the possibility to perform both CBCT and PAN exam with the same flat panel. In order to support his new movement and cassette a new version of AUXCBCT board, AUXCBCT Plus, has been developed with the related firmware,

X-MIND trium software is described in detail in Section 13 of this submission.

The following summary table shows a comparison of the functionalities for image processing, enhancing and visualization available in X-MIND trium cleared version and new version that includes LD functionality

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Via Roma, 45 21057 Olgiate Olona (VA)

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

Please note that 3D functionality are now covered by clearance K173041

| Software characteristic | X-MIND trium
2D analysis + AIS 3D app | X-MIND trium
2D analysis + AIS 3D app | Change Id |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------|
| Supported Image format | DICOM, JPEG, BMP, TIFF, GIFF, PNG, DGI (proprietary format) | DICOM, JPEG, BMP, TIFF, GIFF, PNG, DGI (proprietary format) | same |
| Functionalities and features for 2D images:
single 3D tomographic sections, panoramic and cephalometric radiographs | | | |
| Basic image visualization features | + Zoom and pan

Rotation
Flipping / mirroring, vertical / horizontal | + Zoom and pan
Rotation
Flipping / mirroring, vertical / horizontal | same |
| Measuring function | + Measuring distances
Measuring angles
Adding annotation
Viewing Pixel profile | + Measuring distances
Measuring angles
Adding annotation
Viewing Pixel profile | same |
| Visualization filters | + Gamma filter
Sharp filter
Equalize filter
Emboss filter
Reverse filter | + Gamma filter
Sharp filter
Equalize filter
Emboss filter
Reverse filter | same |

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Image /page/32/Picture/0 description: The image shows the logo for ACTEON. The logo features the company name in bold, sans-serif font. A blue swoosh graphic is located to the left of the company name, adding a dynamic element to the design.

VOL. 005

510/k) Summarv

002_k Summary

510(K) Summary

| Pseudocolour
analysis LUTs | + Gray

Inverse Spectrum | + Gray
Inverse Spectrum | same |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Windowing | + Contrast-brightness set
Lower-Upper level
SHS optimal windowing | + Contrast-brightness set
Lower-Upper level
SHS optimal windowing | same |
| Reporting | Included | Included | same |
| Functionalities and features for CBCT 3D dataset | | | |
| Basic image
visualization
features | + Zoom and pan
Rotation
Flipping / mirroring, vertical / horizontal | + Zoom and pan
Rotation
Flipping / mirroring, vertical / horizontal | same |
| Measuring
function | + Measuring distances
Measuring angles
Adding annotation
Viewing Voxel profile
Measuring polygon
Measuring volumes
Measuring distance on 3D | + Measuring distances
Measuring angles
Adding annotation
Viewing Voxel profile
Measuring polygon
Measuring volumes
Measuring distance on 3D | same |
| Processing filters | + Sharp filter | + Sharp filter | same |

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VOL. 005

510(k) Summary

002_k Summary

| | + Median filter

SHARP filter: denoiser and
edge enhancer
STAR filter: streak and metal
artifacts reduction | + Median filter
SHARP filter:
denoiser and edge
enhancer
STAR filter: streak
and metal artifacts
reduction | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------|
| Multi Planar
Reconstruction
(MPR) | + Axial plane
Coronal plane
Sagittal plane | + Axial plane
Coronal plane
Sagittal plane | same |
| Oblique MPR | Included | Included | same |
| Single and multiple
cross sections
visualization | Included
Setting number of sections
Setting distance of sections | Included
Setting number of
sections
Setting distance of
sections | same |
| Windowing | + Contrast-brightness set
Lower-Upper level
Editing preset | + Contrast-brightness
set
Lower-Upper level
Editing preset | same |
| Display mode | + MPR (voxel intensity)
Ray Sum
Maximum intensity
projection (MIP)
Minimum intensity projection
(minMIP)
SCOUT | + MPR (voxel
intensity)
Ray Sum
Maximum intensity
projection (MIP)
Minimum intensity
projection (minMIP) | same |

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21057 Olgiate Olona (VA)

Via Roma, 45

X-MIND trium

VOL. 005

510(k) Su

Volume thickness selection

(for MIP and Ray Sum)

510(k) Summary

SCOUT
Volume thickness selection (for MIP and

002_k Summary

		Selection (for MIP and Ray Sum)
3D volume
rendering	+ Preset template

Editing of user-defined
template | + Preset template
Editing of user-
defined template | same |
| Surface Rendering | + Surface generation
STL export | + Surface generation
STL export | same |
| Curve Planar
Reformation (CPR)
for dental analysis | + Dentascan wizard | + Dentascan wizard | same |
| Advanced 3D
visualization tools | + 3D clipping: 3D cut by
orthogonal planes
3D thin slab rendering
3D sculpting: 3D cut by user-
defined planes
3D flying mode: 3D virtual
endoscopy | + 3D clipping: 3D cut
by orthogonal planes
3D thin slab
rendering
3D sculpting: 3D cut
by user-defined
planes
3D flying mode: 3D
virtual endoscopy | same |
| Advanced 3D
functions | + Implant planning wizard
Nerve tracing
Importing 3D STL object in
patient volume
STL implant library
Measuring bone density at
implant sites | + Implant planning
wizard
Nerve tracing
Importing 3D STL
object in patient
volume
STL implant library | same |

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VOL. 005

Via Roma, 45 21057 Olgiate Olona (VA) 510(k) Summary

002_k Summary

Bone/tissue removal + Measuring bone density at implant sites + Bone/tissue removal General purpose functionalities Image capture (AIS 3D Screenshot capture Image capture (AIS 3D app) same function app) 2D analysis module (Export) 2D analysis module (Export)

Table 8: comparison between Acteon Imaging Suite and predicate device software.

The above tables show that the two devices have the same intended use.

We have conducted the risk analysis and the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements according to our design and development procedure in compliance with 21 CFR § 820.30 and design control quidance for medical device manufacturers.

The impact of the modification on the device and its components on the risk has been evaluated Re-applying Fault Tree Analysis (FTA) and identifying additional events that can generate undesired consequences (top events) originally identified with Preliminary Hazard Analysis (PHA),

Change in detectors have been verified following "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"

Bench testing was used to evaluate the trade-off between the image quality and radiation dose of the images obtained with dose reduction due to addition of two main aspects:

1. TLD cassette (when using special exam for child)
1. Low Dose functionality, CBCT mode only

Based on the bench test results on image quality and radiation dose obtained with X-MIND trium cleared device and X-MIND trium proposed device (with TLD cassette and separately with Low Dose functionality), we can assume that the clinical performance obtained with the above changes is equal or better than the ones of the predicate device; these results, confirm the equivalence of X-MIND trium proposed device to X-MIND trium predicate device.

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|--|

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510(k) Summary

002_k Summary

Via Roma, 45 21057 Olgiate Olona (VA)

| I
d | Device Change | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 1 | New PAN detector | 21A. Ionising
radiation
hazard
Harm:
biological
effects due
to X-ray
ionising
radiation due
to
event 4)
Unwanted
x-ray
exposure
due to poor
image
quality
(inadequate
for
diagnostic
purpose) | Guidance for the
Submission of
510(k)'s for Solid
State X-ray
Imaging Devices" | Same technology
DQE values for new
detector are in the
range ±0.1 on the
whole frequency
range (1 – 4 LP/mm) | Same
PASS |
| 2 | New CEPH detector | 21A. Ionising
radiation
hazard
Harm:
biological
effects due
to X-ray
ionising
radiation due
to event 4) | Guidance for the
Submission of
510(k)'s for Solid
State X-ray
Imaging Devices" | Same technology
DQE values for new
detector are in the
range ±0.1 on the
whole frequency
range (1 – 4 LP/mm) | Same
PASS |

³ Complete results are available in substantial equivalence discussion section 11 and in specific reports of V&V and bench tests available in sections 15, 16

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|--|

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510(k) Summary

002_k Summary

| I
d | Device Change | Risks | Verification/Validation Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Unwanted x-ray exposure
due to poor image quality
(inadequate for
diagnostic purpose) | | | |
| 3 | New
PAN-
CBCT
detector | 21A. Ionising
radiation hazard
Harm:
biological effects due
to X-ray
ionising
radiation due
to
event 4)
Unwanted
x-ray
exposure
due to poor
image
quality
(inadequate
for
diagnostic
purpose) | Bench test
according to same
protocol used in X-
MIND trium
Submission
K160166 | Same or superior
trade-off between
dose and image
quality (i.e. System
Indicator (SI) in CBCT)
$S_{DAP} \ge S_{DAP ; predicate}$
$S_{DAP} = \frac{CNR}{DAP \cdot (\frac{1}{2 \cdot V_{50%}})^2}$
CNR is the contrast to
noise ratio (overaged
value from 5
measurements)
DAP is the dose area
product declared in IFU
V50% is the resolution
indicator at 50%
modulation | Woman
Medium
Standard
quality
FOV
80X80-
80X90
$S_{DAP} ; TLD =$

SDAP
pred
PASS
Woman
Medium
Standard
quality
FOV
110X80
$S_{DAP} ; TLD >$
PASS
Child
medium |

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ACTEONVOL. 005

002_k Summary

510(k) Summary

| I
d | Device Change | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|---------------|-------|----------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------|
| | | | | | Standard
d quality |
| | | | | | FOV
80X80-
80X90 |
| | | | | | SID Adult |
| | | | | | SDAP TLD >
SDAP pred |
| | | | | | PASS |
| | | | | | Child
medium
Standard
d quality |
| | | | | | FOV
80X80-
80X90 |
| | | | | | SID Child |
| | | | | | SDAP TLD >
SDAP pred |
| | | | | | PASS |
| | | | Voxel Noise [a.u.] with
TLD cassette including
new PAN-CBCT sensor
(VNTLD) ≤ Voxel Noise
[a.u.] predicate (VN) | | Woman
Medium
Standard
quality
FOV |
| | | | | | 80X90- |

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ACTEONVOL. 005

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510(k) Summary

| I
d | Device Change | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|---------------|-------|---------------------------------------|---------------------|--------------------------------------------------|
| | | | | | VNTLD >2.5
respect to
local
collapse
PASS |
| | New
Child
special
exam | 29A
Unintended
use of the
device due to | IEC 60601-1-6 | The criteria to pass
usability verification
are that all the
comments are
positive. | PASS | |

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45

| Via Roma, 45
21057 Olgiate Olona (VA) | | | | X-MIND trium
510(k) Summary | | | VOL. 005
002_k Summary | | |
|------------------------------------------|-----------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--|-----------------------------------------------|--|--|
| I
d | Device Change | | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | | Summary
of results | | |
| | | | human
factors
Event 6)
Misplace
adult
patients
during child
exam
Inadequate
arrangeme
nt of
controls
and
indicators | | | | | | |
| | New tool
Child
special
exam | | 4C. Contact
allergy due
to
Inappropriat
e materials,
not
biocompatibl
e | Same material,
same plastic
injection process
of chin rest, bite
block
ISO 10993-5: 2009 | Cytotoxicity:
No cytotoxic | | PASS | | |
| | | | | ISO 10993-10:
2010 | Hypersensitivity:
Not sensitizing - | | PASS | | |
| | True Low
dose
(TLD)
(reductio
n of SID) | | 21A. Ionising
radiation
hazard
Harm:
biological
effects due
to X-ray | Bench test PAN
mode according to
same protocol
used in X-MIND
trium Submission | Absence of artifacts
Equal Hight contrast
resolution | | Both
verified
PASS
Both 3.1
lp/mm | | |

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VOL. 005

003

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Image /page/46/Picture/8 description: The image shows the word "ACTEON" in bold, sans-serif font. A curved, blue line is located to the left of the word. The word is in all capital letters and is slightly slanted to the right. The background is white.

VOL. 005

Via Roma, 45 21057 Olgiate Olona (VA)

510(k) Summary

I Device Change Risks Verification/Validat Acceptance Criteria Summary d ion Method(s) of results 3 ionising K160166 PASS radiation due to Equal Low contrast Both 4 event 4) resolution holes Unwanted visible x-ray exposure PASS due to poor Declared DAP PAN 38.77 1 DAP SDAP pred 2.Vzm/ is the contrast to noise PASS

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VOL. 005

510(k) Summary

002_k Summary

| I
d | Device Change | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|---------------|-------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | | | | ratio (overaged value
from 5 measurements)
DAP is the dose area
product declared in IFU
V50% is the resolution
indicator at 50%
modulation | Woman
Medium
Standard
quality
FOV
110X80
SDAP TLD >
SDAP pred
PASS |
| | | | | | Child
medium
Standard
d quality
FOV
80X80-
80X90
SID Adult
SDAP TLD =

SDAP
pred
PASS |

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ACTEON VOL. 005

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510(k) Summary

| I
d | Device Change | Risks | Verification/Validat
ion Method(s) | Acceptance Criteria | Summary
of results
3 |
|--------|---------------|-------|----------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| | | | | | Child
medium
Standard
d quality |
| | | | | | FOV
80X80-
80X90 |
| | | | | | SID Child |
| | | | | | SDAP TLD >
SDAP pred
PASS |
| | | | Voxel Noise [a.u.] with
TLD cassette including
new PAN-CBCT sensor
(VNTLD) ≤ Voxel Noise
[a.u.] predicate (VN) | | Woman
Medium
Standard
quality |
| | | | | | FOV
80X90- |
| | | | | | VNTLD 5A Biological
effects due
to X-ray
ionising
radiation.
2)
Unwanted
X-ray due to
unsuitable
or fault
shielding
(causing
leakage
radiation),
filtration or
collimation | IEC 60601-2-63
203.8.5.3
Correspondence
between X-RAY
FIELD and
EFFECTIVE IMAGE
RECEPTION AREA
(rectangular area) | c) along each of the
two axes of the IMAGE
RECEPTION AREA, the
edges of the X-RAY
FIELD
shall not exceed the
corresponding edges
of the EFFECTIVE
IMAGE RECEPTION
AREA by
more than 2 cm or 3 %
of the indicated FOCAL
SPOT TO IMAGE
RECEPTOR DISTANCE
when
the IMAGE RECEPTION
PLANE is normal to the
X-RAY BEAM AXIS,
whichever the larger; | SID Adult
edge
4 with
respect to
yielding
(local
plastic
strains)

4 with
respect to
local
collapse |

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| Via Roma, 45
21057 Olgiate Olona (VA) | | X-MIND trium
510(k) Summary | | VOL. 005
002_k Summary | |
|------------------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| I
d | Device Change | Risks | Verification/Validation Method(s) | Acceptance Criteria | Summary of results |
| 7 | The Low Dose functionality | X-ray:
AIS 5
14
Biological effects due to X-ray
ionising radiation
Event 2:
Overexposu re of X-ray due to the need of exposure to be repeated due to
fault in AIS software functions - New acquisition | Bench test according to same protocol used in X-MIND trium Submission K160166 | Same or superior trade-off between dose and image quality (i.e. System Indicator (SI) in CBCT)
SDAP low dose≥ SDAP standard protocol
$S_{DAP} = \frac{CNR}{DAP \cdot (\frac{1}{2 \cdot V_{50%}})^2}$
CNR (average on 5 measurements)
DAP (declared in IFU) | Man
SDAP low dose >
SDAP standard protocol
PASS
Woman
SDAP low dose >
SDAP standard protocol
PASS
Child
SDAP low dose >
SDAP standard protocol
PASS |

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VOL. 005

002_k Summary

510(k) Summary

| I

d	Device Change	Acceptance Criteria
		$\Delta%VN \le 10%$ $\Delta%VN = \frac{VNld - VNs}{100 + VNsd}$ VNld = Voxel Noise [a.u.] low dose protocol
VNsd = Voxel Noise [a.u.] standard protocol	Man
$\Delta VN%