X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMI and sinus exams). The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth. The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D). The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].

Device Description

X-MIND prime is an X-ray device for the radiographic analysis of the maxillo-facial complex.

X-MIND prime performs Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, Sinus, TMJ, AP and LL cephalometric exams, Carpus exam.

X-MIND prime system can be used with the following type of patient:

Patient population: the target patient population includes adults and pediatric patients from 7 . years old [~25 kg (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
. Patient status:
- . self-sufficient patient (the patient can autonomously place himself as requested by the physician)
non self-sufficient patient (the patient is assisted by medical personnel) .
in any case the patient must be conscious, not anaesthetized and not incapacitated ・
. Nationality: multiple.

X-MIND prime device consists of the following parts: Control panel, Detector group, Fixed arm, Telescopic Column, Patient handgrip, Patient support, X-ray generator, Rotating arm, CEPH arm (optional), CEPH craniostat (optional), CEPH 2ry collimator (optional), Detector (optional).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the X-MIND prime device, structured as requested:

Acceptance Criteria and Device Performance Summary

Unfortunately, the provided document does not explicitly list specific acceptance criteria in a quantitative format (e.g., minimum accuracy, sensitivity, or specificity thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and compliance with regulatory standards.

The document implies that the acceptance criteria are met by demonstrating:

Substantial equivalence to the predicate device (Rotograph Evo D) and reference devices (DENTIOIII series, Rotograph Prime) in terms of intended use, technological characteristics, and performance.
Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601 series, IEC 62304, etc.).
Quality of images is adequate for clinical purposes, specifically for cephalometric images and child panoramic images, as evaluated by independent reviewers or bench testing.
Compliance with USA Code of Federal Regulations relating to performance standards for ionizing radiation emitting products (21 CFR §1020.30 and §1020.31).

Given this, I cannot create a table of "acceptance criteria and reported device performance" as no specific numerical performance metrics are provided as acceptance criteria within this document. The "reported device performance" in this context refers to the device's technical specifications and functionality being comparable to established, legally marketed devices.

Detailed Study Information

1. A table of acceptance criteria and the reported device performance
As noted above, explicit quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) and corresponding reported performance metrics are not provided in this 510(k) summary. The summary focuses on demonstrating substantial equivalence through qualitative comparisons and compliance with general safety and performance standards.

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

Cephalometric Image Quality Study:
- Sample Size: Not explicitly stated. The document mentions "images taken with proposed device."
- Data Provenance: Not explicitly stated. The study was "performed by an independent reviewer." The device manufacturer (de Götzen S.r.l. – ACTEON Group) is located in Italy, so the data likely originated from Italy or a location where the device was tested. It is implicitly retrospective as images are "taken with" the device.
Child Panoramic Image Quality Bench Test:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. This was a "specific bench test" comparing the proposed device with a reference device. It's a bench test, so it's controlled experimental data, not patient data in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cephalometric Image Quality Study:
- Number of Experts: One ("an independent reviewer").
- Qualifications: "graduated in Dentistry and Dental Prosthetics and Orthognathic."
Child Panoramic Image Quality Bench Test:
- Number of Experts: Not applicable, as this was a bench test for image quality comparison, not a ground truth establishment by clinical experts in the same way.

4. Adjudication method for the test set

Cephalometric Image Quality Study: "performed by an independent reviewer." This implies a single reader assessment, and therefore, no multi-reader adjudication method (like 2+1 or 3+1) was used.
Child Panoramic Image Quality Bench Test: Not applicable.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-powered diagnostic aide for interpretation, so AI assistance for human readers is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. The device itself is the imaging system, not a software algorithm that performs diagnostic analysis. The studies concern the quality of the images produced by the hardware, which would then be interpreted by humans.

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

Cephalometric Image Quality Study: The stated purpose was "evaluating images taken with proposed device performed by an independent reviewer graduated in Dentistry and Dental Prosthetics and Orthognathic." This suggests a form of expert assessment of image adequacy for clinical purpose, rather than a comparison to a definitive "ground truth" like pathology for a specific diagnosis. The "ground truth" here is the expert's judgment of image quality and clinical utility.
Child Panoramic Image Quality Bench Test: This was a visual comparison bench test of image quality between two devices, implying a technical assessment of image characteristics, not a clinical ground truth like pathology.

8. The sample size for the training set

The document does not mention a training set as this is not an AI/machine learning device that requires a training phase. It is an X-ray imaging hardware device.

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

Not applicable, as there is no mention of a training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of the Department of Health and Human Services emblem. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

February 5, 2021

de Götzen S.r.l. % Dario Bandiera Quality Assurance and Regulatory Affairs Manager Via Roma, 45 Olgiate Olona. Varese 21057 ITALY

Re: K203374

Trade/Device Name: X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: November 9, 2020 Received: November 16, 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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) K203374

Device Name

X-MIND prime (under trade mark Acteon) I-MAX (under trade mark Owandy Radiology)

Indications for Use (Describe)

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Acteon, a company whose name is written in bold, sans-serif font. A blue swoosh underlines the company name. Below the logo, the text "Via Roma, 45" is visible, likely indicating the company's address.

21057 Olgiate Olona (VA)

X-MIND prime

VOL. 004

510(k) Summary

Index

I.	SUBMITTER	2
II.	PROPOSED DEVICE	2
III.	PREDICATE DEVICE and REFERENCE DEVICES	2
IV.	DEVICE DESCRIPTION	3
V.	INDICATIONS FOR USE	9
VI.	COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES	10
VII.	PERFORMANCE DATA AND TESTING EVIDENCE.	21
VIII.	FDA GUIDANCE DOCUMENTS	23
IX.	CONCLUSION	23

Rev. n. 2	VOL. 004
01/02/2021	X-MIND prime 510(k) AbbreviatedPage 1 of 24

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Acteon, which is a blue swoosh over the company name in black, followed by the text "Via Roma, 45" in black. The logo is simple and modern. The text is located below the logo. The text is left-aligned.

VOL. 004

001_Summary

21057 Olgiate Olona (VA)

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:	+39 0331 376760
Fax:	+39 0331 376763
Contact person:	Dario Bandiera – dario.bandiera@acteongroup.com
Date:	November 9th, 2020

Table 1: Submitter information

PROPOSED DEVICE II.

Name of the device:	X-MIND prime (under trademark Acteon)I-MAX (under trademark Owandy Radiology)
Common or Usual name:	Dental panoramic and cephalometric system
Classification name:	Extraoral source X-ray system (21 CFR 872.1800)
Regulatory class:	II
Product Code:	MUH

Table 2: Proposed device information

PREDICATE DEVICE and REFERENCE DEVICES III.

Legally marketed devices to which equivalence is claimed is:

PREDICATE DEVICE
Device name	Rotograph Evo D
Manufacturer	Villa Sistemi Medicali
Device product code	MUH
Regulation number	872.1800
Regulation name	Extraoral source x-ray system
Clearance date	May 18th, 2009
510(k) number	K090749

Table 3: Predicate device information

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 2 of 24

{5}------------------------------------------------

Via Roma, 4521057 Olgiate Olona (VA)	X-MIND prime510(k) Summary	VOL. 004001_Summary
----------------------------------------------	--------------------------------	-------------------------

REFERENCE DEVICE #1
Device name	DENTIOIII Series (DENTIOIII, DENTIOIII-S)
Manufacturer	HDX WILL CORP.
Device product code	MUH
Regulation number	872.1800
Regulation name	Extraoral source x-ray system
Clearance date	November 21st, 2018
510(k) number	K181297

Table 4: Reference device #1 information

REFERENCE DEVICE #2
Device name	Rotograph Prime (New proprietary name X-MIND prime)
Manufacturer	de Götzen S.r.l. – ACTEON Group
Device product code	MUH
Regulation number	872.1800
Regulation name	Extraoral source x-ray system
Clearance date	July 6th, 2017
510(k) number	K162190

Table 5: Reference device #2 information

IV. DEVICE DESCRIPTION

NOTE: In the following, all the reference to X-MIND prime are applicable also to I-MAX under trademark Owandy Radiology

X-MIND prime is an X-ray device for the radiographic analysis of the maxillo-facial complex.

X-MIND prime system can be used with the following type of patient:

Patient population: the target patient population includes adults and pediatric patients from 7 . years old [~25 kg (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians
. Patient status:
- . self-sufficient patient (the patient can autonomously place himself as requested by the physician)

Rev. n. 201/02/2021	X-MIND prime 510(k) Abbreviated	VOL. 004Page 3 of 24
-------------------------	---------------------------------	--------------------------

{6}------------------------------------------------

ACTEON
Via Roma, 45
21057 Olgiate Olona (VA)

X-MIND prime
510(k) Summary

VOL. 004
001_Summary

non self-sufficient patient (the patient is assisted by medical personnel) .
in any case the patient must be conscious, not anaesthetized and not incapacitated ・
. Nationality: multiple.

OVERVIEW OF THE DEVICE

The reason of the present submission is the introduction of a significative change on X-MIND prime device (listing number D342124 and FDA clearance K162190).

This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime, as shown in overview figure below:

Image /page/6/Figure/7 description: The image shows two dental X-ray machines, labeled as 'X-MIND prime without CEPH arm' and 'X-MIND prime with CEPH arm'. Both machines have several parts marked with numbers from 1 to 8, while the 'X-MIND prime with CEPH arm' also has parts marked with numbers 9 to 12. The image serves to illustrate the different components of the X-ray machines and highlight the distinction between the models with and without the CEPH arm.

Figure 1: overview of the scanner in the configurations without and with the cephalometric arm

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 4 of 24

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Acteon. The logo is black text with a blue swoosh underneath. The text is bold and sans-serif.

VOL. 004

(k) Summary

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

001_Summary

summary

X-MIND prime device consists of the following parts:

1	Control panel	The control panel provides an intuitive overview of the system andhold the keys to move up and down the column, turn on and offthe positioning lasers and reset the device to the start examposition.Image: Control Panel
2	Detector group	It contains the PAN/CEPH detector for the acquisition of theradiographic images of the maxillo-facial region. When placed onthe rotating arm, the detector is ready for the acquisition ofpanoramic images. Further, the detector can be moved from therotating arm to the cephalometric arm in order to perform thecephalometric examinations.
3	Fixed arm	It supports the rotating arm.
4	Telescopic Column	The telescopic column supports and moves the entire structure ofthe medical device.In the version without CEPH arm it is fixed to the wall without anyfootrest;in the version with CEPH arm it is fixed to the wall and resting onthe floor.
5	Patient handgrip	Handgrips held by the patient during the exam.
6	Patient support	The patient support allows to stabilise and immobilise the patient.It is equipped with tools to position the patient head to fit thepatient's anatomy to the Field of View (FOV).
7	X-ray generator	The X-ray assembly is the source of the X-ray beam during theexams. The beam is modelled by a collimator; the electroniccontrol ensures precision and accuracy of selected loading factors(kVp and anodic current). The tubehead aluminium additionalfiltration fits the CFR 21 part 1020.30 and remove low-energyionising radiations, obtaining suitable radiation quality whilereducing the dose absorbed by the patient.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021	Page 5 of 24

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Acteon. The logo is in black, with a blue swoosh underneath the first few letters. The text is bold and sans-serif.

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

510(k) Summary

8	Rotating arm	The rotating arm supports the detector and the X-ray generator.This is the rotating part of the medical device, which moves aroundthe patient during the image acquisition phase of panoramicexams.
9	CEPH arm	In the version of X-MIND prime with cephalometric arm, it allowsthe execution of cephalometric exams: radiographic images ofthe patient skull in LL and AP views and of the patient's wrist toevaluate the bone growth (using the carpus plate provided withthe cephalometric function).
10	CEPH craniostat	The craniostat is the patient positioning aiming device (composedby ear and nasion rest) for the cephalometric exams.
11	CEPH 2ry collimator	The CEPH 2ry collimator is translating during X-Rays in sync withCEPH detector and 1ry collimator (to collimate on CEPH detectorthe X-Ray beam emerging from the generator).
12	Detector	When mounted on the cephalometric arm, detector is translatingduring X-Rays in sync with CEPH 2ry collimator and 1ry collimator(to generate radiographic images of the patient skull in LL and APviews and of the patient's wrist).

Table 6: X-MIND prime parts

Rev. n. 201/02/2021	X-MIND prime 510(k) Abbreviated	VOL. 004Page 6 of 24
-------------------------	---------------------------------	--------------------------

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Acteon. The logo is in black and has a blue swoosh underneath the left side of the word. The word "ACTEON" is in all caps and in a bold sans-serif font.

EQUIPMENT CONFIGURATIONS

X-MIND prime can be sold in these different configurations:

PAN

In this configuration, X-MIND prime is equipped only with the PAN detector which allows to acquire the panoramic exams.

PAN / CEPH

The equipment can carry out the panoramic and cephalometric exams.

The device is equipped with a PAN/CEPH detector which allows to acquire both panoramic and cephalometric exams. The PAN/CEPH detector can be moved from the rotating arm to the cephalometric arm and viceversa, according to the type of exam to be performed.

LIST OF EXAMS

X-MIND prime is a complete panoramic X-ray system that can perform the following exams:

2D examination programs

. Standard Panoramic exam
TM| closed and open mouth: 4 slices are taken in the same image (left/right condyle, open/close . mouth). Condyles are examined in lateral projection
TMJ single phase .
. Sinus P/A projection: one P/A projection, where both the maxillary sinuses are represented.
Half Panoramic (left/right): panoramic acquired only on the right or left side of the mouth .

. Ortho Rad Panoramic: panoramic projection limited to the dentition, obtained with X-ray beam constantly perpendicular to the arch. It allows to reduce superimposition of adjacent teeth and to improve visualization of possible interproximal caries

. Frontal Dentition: panoramic limited to the frontal dentition (canine to canine), that allows to improve the detail definition on incisors

. Low Dose Panoramic: panoramic with reduced angle of rotation to exclude the ascending ramus from the image. The result is a panoramic limited to the dentition area using a reduced patient dose

. Bitewing (Left/Right/Left and Right): the left or right projection allows the examination of lateral dentition (from eighth to fourth approximately), with optimized trajectory of rotating arm for a higher orthogonality of the x-ray beam on the adjacent teeth, to improve visualization of possible interproximal caries. Left and Right Bitewing projection performs both Bitewing views in sequence, joining them on the same image

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 7 of 24

{10}------------------------------------------------

21057 Olgiate Olona (VA)

Via Roma, 45

X-MIND prime

Cephalometric examination programs

Cephalometric L-L projections (with formats 18x24, 24x24, 30x24 and 18x18, 24x18, 30x18): exam . of the skull acquired in lateral projection. The selection between HS High Speed and HD High Definition is available.
Cephalometric A-P projections (with formats 24x24 and 24x18): exam of the skull acquired in . frontal position. The selection between HS High Speed and HD High Definition is available.
. Carpus Projection (with format 18x24): exam specifically intended for evaluating the state of calcification and the patient's bone growth trend. The exam is available only in HD High Definition mode.

For each exam it is possible to select patient type (Adult or Child) and the patient size (small, medium, large) to allow the automatic selection of the pre-set exposure parameters. Otherwise, the user has the possibility to select the exposure parameters manually, with a high voltage ranging between 60 and 86 kV in 2 kV steps, and with the anodic current ranging from 2 mA to 12.5 mA with R20 scale steps.

PRINCIPLES OF OPERATION

The X-ray generator and the detector (PAN/CEPH) are the most important parts of the X-MIND prime device and allow the acquisition of the radiographic images of the maxillofacial complex. The PAN/CEPH detector and the X-ray source are mounted on the rotating arm of the device. The detector can be moved from the rotating arm to the cephalometric arm when the cephalometric examinations must be acquired.

During the panoramic exams, the rotating arm rotates up to 200° (depending on the selected exams) around the patient's head, and the detector acquires a set of radiographic images. A collimator ensures an efficient use of the radiation, minimising the exposed area only on the anatomical region of interest.

The raw images are processed to obtain a 2D panoramic image.

In order to acquire the cephalometric exams, the detector performs a horizontal linear scanning of the skull, while the focus is kept in a fixed position and guaranteeing the same projection geometry as if using a film. The X-ray source is automatically aligned to digital sensor. The use of a secondary collimator on the cephalometric arm ensures the minimum level of radiation to the patient limiting the size of the fan shaped beam to the target region of interest. A digital filter is automatically applied to lateral cephalometric images to enhance the visibility of soft tissues profile while preserving the bone structures.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 8 of 24

{11}------------------------------------------------

ACTEON Logo

	Via Roma, 45
--	--------------

21057 Olgiate Olona (VA)

X-MIND prime

INDICATIONS FOR USE V.

X-MIND prime (and I-MAX under trade mark Owandy Radiology) is an extra-oral dental panoramic X-ray unit to take two dimensional radiographic exams of teeth, jaw and oral structures (panoramic, TMJ and sinus exams). The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth. The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D).

The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height].

Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 9 of 24

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a stylized wave-like design in blue on the left side. The text "ACTEON" is in bold, sans-serif font.

VOL. 004

001_Summary

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE and REFERENCE DEVICES

NOTE: In the following, all the reference to X-MIND prime are applicable also to I-MAX under trademark Owandy Radiology

	Proposed device:X-MIND prime	Predicate device:Rotograph Evo D	Referencedevice #1:DENTIOIII series(DENTIOIII,DENTIOIII-S)	Referencedevice#2:Rotograph Prime
IntendedUse	X-MIND prime is anextra-oral dentalpanoramic X-rayunit to take twodimensionalradiographic examsof teeth, jaw andoral structures(panoramic, TMJand sinus exams).The models withcephalometric armwill be able to taketwo dimensionalcranialcephalometricexams in differentprojections and thewrist exam (Carpus)dedicated to theevaluation of thebone growth.	Rotograph Evo D,panoramic x-rayimaging systemswith cephalostat,are extraoral sourcex-ray systems,which are intendedfor dentalradiographicexamination of theteeth, jaw, and oralstructures,specifically forpanoramicexaminations andimplantology andfor TMJ studies andcephalometry.		Rotograph Prime isan extra-oral dentalpanoramicX-ray unit toradiograph teeth,jaw and oralstructures.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 10 of 24

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a blue swoosh on the left side. The text is in all caps and is bolded.

VOL. 004

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

001_Summary

Proposed device:X-MIND prime	Predicate device:Rotograph Evo D	Referencedevice #1:DENTIOIII series(DENTIOIII,DENTIOIII-S)	Referencedevice#2:Rotograph Prime
The device isoperated and usedby dentists,radiologists andother legallyqualified health careprofessionals, i.e.Prescription Use(Part 21 CFR 801Subpart D).The target patientpopulation includesadults and pediatricpatients from 7years old [~27 kg(59.5 lb); 125 cm(49.2 in) standingheight].Anyway, thesustainability to X-ray exposure mustbe evaluated bysurgeons, dentistsand qualified andauthorizedphysicians		The DENTIOIIIseries is intendedfor dentalradiographicexamination of theteeth andtemporomandibularjoints, specificallyfor panoramic andcephalometricexaminations. It isto be used only bydental practitionersand/or radiologists	The device isoperated and usedby dentists,radiologists andother legallyqualified health careprofessionals.It can be used withboth pediatric andadult patients.

Table 7: Comparison of the intended use among proposed and predicate devices.

Rev. n. 2		VOL. 004
01/02/2021	X-MIND prime 510(k) Abbreviated	Page 11 of 24

{14}------------------------------------------------

Via Roma, 45

X-MIND prime

Detailed comparison of similarities and differences

The intended use of the proposed device and of the predicate device are the same:

They have the same functions in the same environment. in particular, the proposed device performs the same exams for the examination of teeth, jaw, oral structures, cranial cephalometric exams in different projections and the wrist exam

The intended use of the proposed device is taken from labelling (operator's manual) for this reason it is intended to be explicative and as detailed as possible to be clear for the intended user, the intended use of Rotograph Evo D, is taken from "Indications for use" available in K090749 Summary and it is more synthetic in the form but it covers all the proposed device intended use

The following table highlights the existing similarities between the proposed device and the predicate device.

	Proposed device:X-MIND prime	Predicate device:Rotograph Evo D
2D Examination programs
Panoramic exam	Yes	Yes
Ortho Rad Panoramic	Yes	Yes
Segmented Panoramic (Halfpanoramic, frontal dentition,bitewings)	Yes	Yes
Low dose panoramic	Yes	Yes
TMJ Closed/Open mouth	Yes	Yes
TMJ single phase	Yes	Yes
Sinus	Yes	Yes
2D Exam characteristics
Magnification (Panoramic)	1.23 constant	1.23 constant

Rev. n. 2		VOL. 004
01/02/2021	X-MIND prime 510(k) Abbreviated	Page 12 of 24

{15}------------------------------------------------

ACTEON

X-MIND prime

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

510(k) Summary
----------------

	Proposed device:X-MIND prime	Predicate device:Rotograph Evo D
Source to image distance	500 mm	500 mm
Magnification (cephalometric)	1.1 constant	1.1 constant
Source to image distance(cephalometric)	1650 mm	1650 mm
Panoramic max image size	equivalent to 15x30 cm film	equivalent to 15x30 cm film
Adult panoramic scan time	14 sec	13.8 sec
Child panoramic exam withshorter scan time than adultpanoramic exam	12.8 sec	13.8 sec
Cephalometric image sizes	From 18 x 18 to 24 x 30(height x width)	From 24 x 18 to 24 x 30(height x width)
Cephalometric scan time	From 4.4 s to 15.1 s dependingon image size	From 4.5 s to 15 s depending onimage size
Generator/tubecharacteristics
X-ray generator	High frequency	High frequency
Focal spot value	0.5 mm (IEC 60336)	0.5 mm (IEC 60336)
Anode type	Fixed	Fixed
X-ray exposure time control	Automatic - pre-programmedMicroprocessor Controlled	Automatic – pre-programmedMicroprocessor Controlled
Independent kV-mA regulation	Yes	Yes
DAP Software	Yes	Yes

Rev. n. 2		VOL. 004
01/02/2021	X-MIND prime 510(k) Abbreviated	Page 13 of 24

{16}------------------------------------------------

ACTIEOI

X-MIND prime

VOL. 004

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

001_Summary

	Proposed device:X-MIND prime	Predicate device:Rotograph Evo D
kV Range	60 - 86 kV step 2kV	60 - 86 kV step 2kV
Total filtration	2.5 mm Al eq	2.5 mm Al eq
Collimator	Automatic	Automatic
mA range	2 - 12.5 mA	6 - 12 mA
Patient positioning
Height adjustment	Motorized	Motorized
Positioning lights	2 laser pointers	2 laser pointers
Patient position	Standing	Standing
Patient positioning tools	Temple clamps, bite block, chin support	Temple clamps, bite block, chin support
Focal layer adjustment(prognatism compensation)	Electronic, three positions, no patient movement	Electronic, three positions, no patient movement
Patient positioning orientation vs the operator	Face to face	Face to face
Patient positioning tools in cephalometric exams	Ear rods, nasion support	Ear rods, nasion support
User interface
PC connection	Dedicated Giga-Ethernet channel	Ethernet connection
User interface	Onboard keyboard and virtual control panel (on PC)	Onboard keyboard with touchscreen and virtual control panel (on PC)

Rev. n. 201/02/2021	X-MIND prime 510(k) Abbreviated	VOL. 004Page 14 of 24
-------------------------	---------------------------------	---------------------------

{17}------------------------------------------------

ACTHEC

X-MIND prime

VOL. 004

001_Summary

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

	Proposed device:X-MIND prime	Predicate device:Rotograph Evo D
Software
System architecture	Based on multiple CPUsconnected via Can Bus plusEthernet connection to PC	Based on multiple CPUsconnected via Can Bus plusEthernet connection to PC.In this case, the device has twomore CPUs for controlling theonboard GUI and verticalcolumn
Firmware functions(of MCU and CCU ControlProcessing Units) forcontrolling movements andimageacquisition/synchronization	Firmware functions aredesigned to manage thepanoramic version and thecephalometric option. Somedifferences are related tospecific hardware solutions ordifferent microprocessorsfrom the Predicate Device.	Firmware functions aredesigned to manage thefollowing configurations: FilmVersion, digital panoramicversion, cephalometric option
X-ray generator board firmwarefunctions	X-ray parameters (kV, mA)management, X-ray start andstop, errors control.Can Bus communication.	X-ray parameters (kV, mA)management, X-ray start andstop, errors control.Can Bus communication.
Communication protocolbetween the computer andControlling Processing Unitboard.	Proprietary TCP/IP protocol	Proprietary TCP/IP protocol
Software functions (on PC)	Graphical user interface (GUI)to control the machine,TCP/IP communication, imageacquisition and correction;image reconstruction.	Graphical user interface (GUI)to control the machine, TCP/IPcommunication, imageacquisition and correction

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 15 of 24

{18}------------------------------------------------

ACTEON

VOL. 004

001_Summary

510(k) Summary

Via Roma, 45 21057 Olgiate Olona (VA)

Proposed device: Predicate device: X-MIND prime Rotograph Evo D Integration of the specific Integration of a proprietary detector manufacturer SDK; detector SDK; Image acquisition PC memory and disk space PC memory and disk space management and control. management and control. Correction functions for Correction functions are detector are designed by Image correction (defect map, designed by Acteon / Owandy. Acteon / Owandy. Offset offset and flat field) Offset correction is done before correction is done before each acquisition each acquisition The frames acquired by the detector in area mode after The detector acquires images the corrections, are directly in TDI mode, then the 2D examination programs' final elaborated with a shift and software applies the correction add procedure to form the image explained in the previous table final image emulating the TDI raw to form the final imaqe (Time Delay Integration) acquisition mode GUI provides basic image preprocessing capabilities that GUI provides basic image prethe user can enable or 2D examination programs' processing capabilities that the disable. By default they are image pre-processing user can enable or disable. By disabled. This procedure default they are disabled. applies to cephalometric images too Installation Telescopic column Yes Yes 110-240 V, 50/60 Hz 110-120 V, 50/60 Hz Power supply voltage Current rating 14 A 15 A

Table 8: Comparison between the proposed and the predicate device.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 16 of 24

{19}------------------------------------------------

	Via Roma, 45
--	--------------

21057 Olgiate Olona (VA)

X-MIND prime

VOL. 004

001_Summary

The following table is focused on the comparison between the proposed device and the reference device #1.

DENTIOIII series (DENTIOIII, DENTIOIII-S): it is taken in the version with cephalometric arm (DENTIOIII-S) as reference device #1, manufactured by HDX WILL CORP. and cleared by FDA with 510(k) number K181297. The proposed device and the reference device share the same digital acquisition sensor for the cephalometric examinations.

	Proposed device:X-MIND prime	Reference device #1:DENTIOIII series (DENTIOIII,DENTIOIII-S)
Panoramic / Cephalometricimaging detector
Detector model	Xineos-2301	Xineos-2301
Manufacturer	Teledyne DALSA	Teledyne DALSA
Technology	CMOS flat panel with CesiumIodide (CsI) scintillator screen	CMOS flat panel with CesiumIodide (CsI) scintillator screen
Sensor active area (Height xWidth)	228 mm x 6.7 mm	228 mm x 7.0 mm
Pixel size	99 μm x 99 μm	99 μm x 99 μm
Bit depth	14 bit	14 bit
Number of sensor pixels	2304 x 68	2305 x 68
MTF	65% at 1 lp/mm	65% at 1 lp/mm
DQE	57% at 1 lp/mm	57% at 1 lp/mm
Panoramic examinationprograms
Panoramic exam time	14 s	14.2 s

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 17 of 24

{20}------------------------------------------------

ACTEON

VOL. 004

001_Summary

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

	Proposed device:X-MIND prime	Reference device #1:DENTIOIII series (DENTIOIII, DENTIOIII-S)
Panoramic exam	Yes	Yes
TMJ exam	Yes	Yes
Sinus exam	Yes	Yes
Cephalometric examination programs
Exam time	Max 15.1 s (HD) / min 4.4 s (HS)	Max 8.2 s (Normal) / 4.2 s (Fast)
Frontal (AP/PA) projection	Yes	Yes
Lateral (LL) projection	Yes	Yes
Carpus	Yes	Yes
Mechanical characteristics
Source to image distance in panoramic exams	500 mm	535 mm
Source to image distance in cephalometric exams	1650 mm	1735 mm (single detector type)1729 mm (dual detector type)
Type of installation	Floor-Wall mount	Floor mount
Weight (wall mount version)	118 kg	160 kg
Dimensions (wall mount version)	2229.5 mm x 1851 mm x 1205 mm	2309 mm x 1953 mm x 1222 mm

Table 9: Comparison between the proposed and the reference device #1.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 18 of 24

{21}------------------------------------------------

X-MIND prime
--------------	--

VOL. 004

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

To demonstrate that the quality of cephalometric images, acquired by X-MIND prime, is adequate for clinical purpose, we have provided a study evaluating images taken with proposed device performed by an independent reviewer graduated in Dentistry and Dental Prosthetics and Orthognathic

The following table is focused on the comparison between the proposed device and the reference device #2. X-MIND prime (Rotograph Prime) cleared with K162190

The proposed device and the reference device #2 share intended use excluded the cephalometric application and some technical details; moreover the reference device #2 has a Child specific panoramic exam with a shorter scan time as the proposed device.

To establish the equivalence of the image quality between the two devices we have performed a specific Performance Testing – Bench.

	Proposed device:X-MIND prime	Reference device #2:Rotograph Prime
2D Examination programs
Panoramic exam	Yes	Yes
Ortho Rad Panoramic	Yes	Yes
Segmented Panoramic (Halfpanoramic, frontal dentition,bitewings)	Yes	Yes
Low dose panoramic	Yes	Yes
TMJ Closed/Open mouth	Yes	Yes
TMJ single phase	Yes	Yes
Sinus	Yes	Yes

Rev. n. 2		VOL. 004
01/02/2021	X-MIND prime 510(k) Abbreviated	Page 19 of 24

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

Image /page/22/Picture/0 description: The image shows the logo for ACTEON. The logo is in black and has a blue swoosh on the left side. The text is in all caps and is a bold sans-serif font.

VOL. 004

510(

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

001_Summary

	Proposed device:X-MIND prime	Reference device #2:Rotograph Prime
2D Examinationcharacteristics
Magnification (Panoramic)	1.23 constant	1.23 constant
Source to image distance(panoramic)	500 mm	500 mm
Panoramic max image size	equivalent to 15x30 cm film	equivalent to 15x30 cm film
Adult panoramic scan time	14 sec	14.4 sec
Child panoramic exam withshorter scan time than adultpanoramic exam	12.8 sec	13.3 sec
Patient positioning
Height adjustment	Motorized	Motorized
Positioning lights in panoramicexams	2 laser pointers	2 laser pointers
Patient position	Standing	Standing
Patient positioning tools inpanoramic exams	Temple clamps, bite block,chin support	Temple clamps, bite block, chinsupport
Focal layer adjustment(prognatism compensation)	Electronic, three positions, nopatient movement	Electronic, three positions, nopatient movement
Patient positioning orientationvs the operator in panoramicexams	Face to face	Face to face
Height of chin support from thefloor	978-1678 mm	975-1635 mm

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 20 of 24

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

ACTEONVia Roma, 4521057 Olgiate Olona (VA)	X-MIND prime510(k) Summary	VOL. 004001_Summary
----------------------------------------------------	--------------------------------	-------------------------

	Proposed device:X-MIND prime	Reference device #2:Rotograph Prime
User interface
PC connection	Dedicated Giga-Ethernetchannel	Ethernet connection
User interface	Onboard keyboard and virtualcontrol panel (on PC)	Onboard keyboard and virtualcontrol panel (on PC)

Table 10: Comparison between the proposed and the reference device #2.

PERFORMANCE DATA AND TESTING EVIDENCE VII.

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

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

The performance tests were 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 and dental extra-oral X-ray equipment
. compliance with usability requirements
compliance with electromagnetic compatibility requirements. .

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 21 of 24

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

Image /page/24/Picture/0 description: The image shows the logo for ACTEON, a company whose name is written in bold, sans-serif font. A blue swoosh underlines the name. Below the logo is the text "Via Roma, 45" indicating an address.

VOL. 004

21057 Olgiate Olona (VA)

510(k) Summary

001_Summary

The following table shows the standards to which X-MIND prime complies, compared to those related predicated device Rotograph Evo D:

Applied standards
Proposed device:X-MIND prime	Predicate device:Rotograph Evo D
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2(2007)	IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2(2007)
IEC 60601-1-2:2014	IEC 60601-1-2:2007
IEC 60601-1-3:2013	IEC 60601-1-3:2008
IEC 60601-2-63:2017	IEC 60601-2-63:2012
IEC 62304:2015	IEC 62304:2006
ES60601-1: 2005/(R)2012 and A1:2012	ANSI/AAMI ES60601-1: 2005 / A2:2010
CAN/CSA-C22.2 No. 60601-1:08	CAN/CSA-C22.2 No. 60601-1:08
IEC 60601-1-6:2013	IEC 60601-1-6:2010
IEC 62366-1:2015	IEC 62366:2007
ISO 10993-1:2010
ISO 10993-2:2006
ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-12:2012

To assess the quality of the child panoramic images acquired with the proposed device X-MIND prime (PAN/CEPH version) and the reference device#2: Rotograph Prime (PAN version) in order to establish

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021	Page 22 of 24

{25}------------------------------------------------

Image /page/25/Picture/0 description: The image shows the logo for Acteon. The logo features the company name in bold, sans-serif font, with the letters "ACTEON" clearly visible. A stylized, curved graphic element in a light blue color is positioned to the left of the company name, adding a visual accent to the logo.

001_Summary

Via Roma, 45 21057 Olgiate Olona (VA)

the equivalence of the image quality between the two devices we have performed a specific bench test

X-MIND prime has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Requlations relating to PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS USA:

21 CFR §1020.30 Diagnostic x-ray systems and their major components.

21 CFR §1020.31 Radiographic equipment.

FDA GUIDANCE DOCUMENTS VIII.

Here below is shown the list of FDA quidance documents that X-MIND prime conforms to or that we referred during the development

FDA Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s ● dated September 2019
. FDA Guideline Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"dated September 2020
FDA Guideline Recomended Content and format of complete Test reports for NOn-ClinicalBench performance Testing in 510K submission dated December 2019.
FDA Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications" ● dated November 2017
. FDA Guidance for the content of premarket submissions for software contained in medical devices dated May 2005
. FDA Guidance Content of premarket submission for management of cybersecurity October, 2014

IX. CONCLUSION

X-MIND prime has the same indication for use as the predicate and reference device #1. It is based on well-known technology. It shares the same technological characteristics as the predicate and reference devices. It has been tested on the basis of recognized standards and special controls 21 CFR §1020.30, 21 CFR §1020.31.

Minor technological differences,

given results of risk analysis of the changes of X-MIND prime with cephalometric option respect to the predicate device

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 23 of 24

{26}------------------------------------------------

ACTEON	X-MIND prime
Via Roma, 45	510(k) Summary
21057 Olgiate Olona (VA)	VOL. 004
	001_Summary

given results of performance bench with reference device #2,

do not raise any new questions regarding safety or effectiveness of the device, so it is as safe and effective as the predicate device.

Rev. n. 2	X-MIND prime 510(k) Abbreviated	VOL. 004
01/02/2021		Page 24 of 24

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.