X-MIND Trium

• K Number: K191719
• Device Name: X-MIND Trium
• Manufacturer: de Gotzen S.R.L
• Date Cleared: 2020-02-20 ( 239 days)
• Product Code: MUH , OAS
• Regulation Number: 872.1800
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K160166
• Predicate For: N/A

Intended Use

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

• producing panoramic X-ray images for diagnostic examination (teeth), jaws and oral structures;
• producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm;
• producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm;
• producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option.
  From a clinical point of view, X-MIND trium can be applied for the following medical indications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology

Device Description

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. The system consists of the X-MIND trium SCANNER and the OPERATOR'S WORKSTATION. The scanner includes a control panel, X-ray generator, sliding body, U-arm, detector sliding group, CBCT detector, PAN detector, TLD CASSETTE (optional), patient support, F group, and column. The workstation runs ACTEON IMAGING SUITE (AIS) + 2D diagnostic analysis and AIS 3D app for CBCT dataset display software. The device can be configured as PAN only, PAN / CBCT, PAN / CEPH, PAN / CBCT / CEPH (PAN Full), PAN / CBCT TLD version, and PAN / CBCT / CEPH TLD version. It can be wall mounted or self-standing. Main changes include the addition of a new accessory, the X-MIND trium TLD cassette, including a new model of CBCT sensor that can be used for both panoramic and CBCT examination, and the introduction of CEPH and PAN sensors with a wider admitted range of power supply value. A new movement of the cassette has been added to modify the SID, allowing for special exams for children with reduced SID. A new AUXCBCT board has been designed to support the new movement and cassette. A new functionality, the Low Dose functionality, allows for CBCT exams using Low Dose protocols as an alternative to Standard Dose protocols, ensuring a radiation dose saving of about 50%.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the X-MIND trium device, based on the provided document:

Acceptance Criteria and Device Performance

The document describes several changes to the X-MIND trium device, and the acceptance criteria and performance are tied to these specific changes, particularly related to the new PAN-CBCT detector and the Low Dose (LD) functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Device Change / Characteristic	Acceptance Criteria	Reported Device Performance
New PAN Detector (1)	Same technology. DQE values for new detector are in the range ±0.1 on the whole frequency range (1 – 4 LP/mm).	PASS (DQE values are within range, same technology)
New CEPH Detector (2)	Same technology. DQE values for new detector are in the range ±0.1 on the whole frequency range (1 – 4 LP/mm).	PASS (DQE values are within range, same technology)
New PAN-CBCT Detector (3)	Image Quality vs. Dose Trade-off (System Indicator - SI_DAP): Same or superior trade-off between dose and image quality (i.e. System Indicator (SI) in CBCT) $S_{DAP} ≥ S_{DAP ; predicate}$ where $S_{DAP} = \frac{CNR}{DAP \cdot (\frac{1}{2 \cdot V_{50%}})^2}$ (CNR = contrast to noise ratio, DAP = dose area product, V50% = resolution indicator at 50% modulation). Voxel Noise: Voxel Noise [a.u.] with TLD cassette including new PAN-CBCT sensor (VNTLD) ≤ Voxel Noise [a.u.] predicate (VN). Noise Power Spectrum (NPS): NPS0D [a.u.²] with TLD cassette including new PAN-CBCT sensor ≤ NPS0D [a.u.²] predicate. X-ray Field to Image Receptor Correspondence (IEC 60601-2-63): 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, whichever the larger; the sum of the discrepancies on both axes shall not exceed 3 cm or 4 % of the indicated FOCAL SPOT TO IMAGE RECEPTOR DISTANCE, whichever the larger. X-ray Field to Image Receptor Correspondence (21 CFR 1020.31 f) 4)): field does not exceed each dimension of the image receptor by more than 2 percent of the SID; align the center of the x-ray field with the center of the image receptor to within 2 percent of the SID.	Image Quality vs. Dose Trade-off (SI_DAP): - Woman Medium Standard quality FOV 80X80-80X90: SDAP TLD > SDAP pred (PASS) - Woman Medium Standard quality FOV 110X80: SDAP TLD > SDAP pred (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Adult: SDAP TLD > SDAP pred (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Child: SDAP TLD > SDAP pred (PASS) Voxel Noise: - Woman Medium Standard quality FOV 80X90: VNTLD < VN (PASS) - Woman Medium Standard quality FOV 110X80: VNTLD < VN (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Adult: VNTLD < VN (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Child: VNTLD < VN (PASS) Noise Power Spectrum (NPS): - Woman Medium Standard quality FOV 80X90: NPS0D TLD < NPS0D (PASS) - Woman Medium Standard quality FOV 110X80: NPS0D TLD < NPS0D (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Adult: NPS0D TLD < NPS0D (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Child: NPS0D TLD < NPS0D (PASS) X-ray Field to Image Receptor Correspondence (IEC 60601-2-63): - SID Adult edge ≤ 20mm (PASS) - SID Child edge ≤ 20mm (PASS) - Sum of discrepancies: < 30mm (PASS) - Along scanning axis: ≤ 1mm (PASS) - Perpendicular to scanning axis: =0 (PASS) X-ray Field to Image Receptor Correspondence (21 CFR 1020.31 f) 4)): - PAN: ≤ 2% (PASS) - PAN reduced SID: ≤ 2% (PASS) - CBCT: ≤ 2% (PASS) - CBCT reduced SID: ≤ 2% (PASS) - Center alignment (PAN and CEPH only): PASS
New Child Special Exam (4)	Usability (IEC 60601-1-6): All comments are positive. Biocompatibility (ISO 10993-5: 2009 & ISO 10993-10: 2010 for new tool): Cytotoxicity: No cytotoxic. Hypersensitivity: Not sensitizing.	Usability: PASS (all comments positive). Biocompatibility: PASS (no cytotoxicity, not sensitizing, same material and process as predicate)
True Low Dose (TLD) / Reduced SID (4)	Image Quality (PAN mode): Absence of artifacts. Equal high contrast resolution (Both 3.1 lp/mm) and equal low contrast resolution (Both 4 holes visible). Declared DAP (PAN mode): Declared DAP PAN 38.77 < 52. (image CHILD NEDIUM SID) < predicate. Image Quality vs. Dose Trade-off (CBCT mode - SI_DAP): Same or superior trade-off between dose and image quality (i.e. System Indicator (SI) in CBCT) $S_{DAP} ≥ S_{DAP ; predicate}$.	Image Quality (PAN mode): Both verified PASS (Absence of artifacts, 3.1 lp/mm high contrast resolution, 4 holes visible low contrast resolution). Declared DAP (PAN mode): PASS (38.77 < predicate for child). Image Quality vs. Dose Trade-off (CBCT mode - SI_DAP): - Woman Medium Standard quality FOV 80X80-80X90: SDAP TLD > SDAP pred (PASS) - Woman Medium Standard quality FOV 110X80: TLD > pred (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Adult: SDAP TLD = > SDAP pred (PASS) - Child medium Standard quality FOV 80X80-80X90 SID Child: SDAP TLD > SDAP pred (PASS)
Detectability Study (3 & 7)	Same pathological or clinically relevant conditions identifiable both in the STD protocol scan and in the TLD protocol one (for TLD cassette / reduced SID) AND Same pathological or clinically relevant conditions identifiable both in the STD protocol scan and in the LD protocol one (for Low Dose functionality).	TLD cassette / Reduced SID: PASS. All pathological or clinically relevant conditions identified with STD protocol scan have been identified with the LD protocol one. Note Pos. 45 "worn out dental neck" not identified nor in standard mode nor in TLD configuration (this implies both performed equally, neither identified this specific condition). Low Dose Functionality (LD): PASS. All pathological or clinically relevant conditions have been identified both in the STD protocol scan and in the LD protocol one.
Low Dose Functionality (7)	Image Quality vs. Dose Trade-off (SI_DAP): Same or superior trade-off between dose and image quality. $S_{DAP low dose} ≥ S_{DAP standard protocol}$. Voxel Noise (VN): $\Delta%VN \le 10%$, where $\Delta%VN = \frac{VNld - VNs}{100 + VNsd}$ (VNld = Voxel Noise [a.u.] low dose protocol, VNsd = Voxel Noise [a.u.] standard protocol). Noise Power Spectrum (NPS): $\Delta%NPS \le 30%$, where $\Delta%NPS = \frac{NPSld - NPSsd}{100 + NPSsd}$ (NPSld = NPS0D [a.u.²] low dose protocol, NPSsd = NPS0D [a.u.²] standard dose protocol).	Image Quality vs. Dose Trade-off (SI_DAP): - Man: SDAP low dose > SDAP standard protocol (PASS) - Woman: SDAP low dose > SDAP standard protocol (PASS) - Child: SDAP low dose > SDAP standard protocol (PASS) Voxel Noise: - Man: $\Delta VN% < 10%$ (PASS) - Woman: $\Delta VN% < 10%$ (PASS) - Child: $\Delta VN% < 10%$ (PASS) Noise Power Spectrum (NPS): - Man: $\Delta NPS < 30%$ (PASS) - Woman: $\Delta NPS < 30%$ (PASS) - Child: $\Delta NPS < 30%$ (PASS)

2. Sample Size and Data Provenance

The document mentions "bench tests" and a "clinical detectability analysis" using "radiographs of cadavers".

• Test Set Sample Size: For the detectability analysis, the "radiographs of cadavers" constitute the test set for evaluating clinical performance. The number of cadavers scanned is not specified in the provided text. The number of specific conditions tested is also not explicitly stated, beyond the general statement of "All pathological or clinically relevant conditions".
• Data Provenance: The data appears to be prospective as it involves new bench tests and a detectability study specifically designed to evaluate the changes in the device. The country of origin of the data is not specified, but the manufacturer is based in Italy.

3. Number of Experts and their Qualifications

• Number of Experts: For the detectability analysis, a "set of intended users" were used. The exact number is not specified.
• Qualifications of Experts: The experts included "radiologist, dentist, oral surgeon." Specific years of experience are not mentioned.

4. Adjudication Method

• The document implies a consensus-based evaluation for the detectability study, stating that experts "evaluated the visibility of anatomical structures and features of interests in the different scanning conditions." However, a formal adjudication method (e.g., 2+1, 3+1, none) is not explicitly described. It states that "All pathological or clinically relevant conditions identified with STD protocol scan have been identified with the LD protocol one," suggesting an agreement on findings rather than a formal disagreement resolution process between multiple readers.

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

• A comparative effectiveness study in the sense of comparing human reader performance with and without AI assistance is not explicitly described or quantified.
• The detectability study compares the device's performance (standard vs. low dose protocols) by assessing whether experts can identify pathological conditions in both, rather than assessing the uplift in human reader performance using AI. The changes described are enhancements to the imaging system itself (new detector, low dose protocols, reduced SID), not an AI-assisted diagnostic tool for readers.

6. Standalone Performance Study

• Yes, standalone performance studies were conducted for various technical aspects of the device. The document details extensive "bench testing" to evaluate parameters like:
  • DQE values for new PAN and CEPH detectors.
  • Trade-off between dose and image quality (SI_DAP) for the new PAN-CBCT detector and Low Dose functionality.
  • Voxel Noise and Noise Power Spectrum.
  • X-ray field to image receptor correspondence.
  • Mechanical stability (Self-standing version).
• These tests were performed on the algorithm/device itself without human-in-the-loop intervention for the quantitative measurements, demonstrating the technical performance of the device's imaging capabilities.

7. Type of Ground Truth Used

• For the detectability analysis: The ground truth appears to be based on the identification of "pathological or clinically relevant conditions" by the experts in the standard protocol scan. The low dose scan was then compared against this baseline to ensure similar conditions could be identified. This suggests a form of expert consensus or established clinical findings from the standard protocol as the reference.
• For the bench tests: The ground truth for technical parameters (DQE, CNR, DAP, Voxel Noise, NPS, field correspondence) is based on physical phantom measurements and engineering standards/specifications (e.g., IEC standards, physical dimensions, signal characteristics).

8. Sample Size for the Training Set

• The document describes changes to a medical imaging device (X-ray system), not an AI algorithm that requires a "training set" in the context of machine learning. Therefore, a training set sample size is not applicable in the conventional sense. The device's operation is based on established physics and engineering principles, and its performance is validated through bench tests and clinical detectability studies.

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

• As explained above, the concept of a "training set" in this context is not applicable for an X-ray imaging system. The system's functionalities are developed based on engineering design, and its performance is validated against physical and clinical criteria, not by training on a dataset with pre-established ground truth.

Summary

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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

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

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191719

Device Name X-MIND trium

Indications for Use (Describe)

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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ACTEONVia Roma, 4521057 Olgiate Olona (VA)	X-MIND trium510(k) Summary	VOL. 005002_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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Via Roma, 45

X-MIND trium

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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.	[phone]
Fax	[phone]
Dario Bandiera	[e-mail]
Alvise Reither	[e-mail]
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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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

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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
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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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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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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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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 2Image: Radioactivity symbol and remote control	- Control cable, 10 wires, 5 twisted pairs 10 m long aluminiumshielded- X-MIND trium Remote Control- X-MIND trium Light
Part 3Image: 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 60601-1)

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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.

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

1	Control panel	The control panel provides an intuitive overview of the system tomove the mobile column, turn the positioning lasers on and offand activate the X-MIND trium medical device.
2	X-ray generator	The X-ray assembly is the source of the X-ray beam during therotation of the U-Arm. The pulsed beam is modelled by anautomatic collimator, whereas the electronic control ensuresstability and accuracy of the selected loading factors (exposuretime, kVp and anodic current). An aluminium filter is used toharden the beam and remove low-energy ionising radiations,thereby obtaining suitable radiation quality whilst reducing itsdose 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-raygenerator. This is the rotating part of the medical device, whichmoves around the patient during the image acquisition phase.
5	Detector slidinggroup	It contains detectors that allow acquire images. This cassette canbe provided in the following versions:PAN Only cassette; Standard PAN/ CBCT Cassette; TRUE LOW DOSE cassette that permit to perform both PANand CBCT exams. (* only with X-MIND trium TLD version)
6	CBCT detector	This flat panel detector is indicated for use in generatingradiographic images of the maxillo-facial region, more specificallyit is dedicated for CBCT acquisitions.in X-MIND trium TLD version there is only one image detector, forPAN and CBCT exam; the equipment automatically exposes infront of X-Ray source the right portion of detector, depending onthe selected exam;
7	PAN detector	This flat panel detector is indicated for use in generatingradiographic images of the maxillo-facial region, more specificallyit is dedicated for PAN acquisitions.

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	* in X-MIND trium TLD version there is only one image detector,for PAN and CBCT exam; the equipment automatically exposes infront of X-Ray source the right portion of detector, depending onthe selected exam;
7	TLD CASSETTE*	* only for X-MIND trium TLD versionSliding cassette that lets to activate true low dose exams.Some models of X-MIND trium can be upgraded in the field to TLDcassette configuration.
8	Patient support	The patient support allows stabilising and immobilising thepatient. It is equipped with instruments to move the patient'shead in all directions and find the best superimposition betweenthe patient's anatomy and the Field of View (FOV).
9	F group	It is the whole assembled mobile group of the device. It is themoving part of the medical device, which adapts the acquisitiongeometry to the patient's anatomy and stance (sitting orstanding). It supports the U-Arm and head support.
10	Column	The fixed column supports the entire structure of the medicaldevice. This contains the motor that raises and lowers the mobilecolumn, the main control panel of the system and the main switch.In the wall installation version, the fixed column is equipped withan 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 medicaldevice)

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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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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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	ChangeId
	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 digitalpanoramic, cephalometric andtomographic extra-oral X-raysystem, indicated for use in:- producing panoramicX-ray images for diagnosticexamination of dentition(teeth), jaws and oralstructures;- producing radiographsof maxillofacial region andparts of the skull forcephalometric examination, ifequipped with CEPH arm;- producing radiographs ofhands and wrists for carpusexamination, if equipped withCEPH arm;	X-MIND trium is a digitalpanoramic, cephalometric andtomographic extra-oral X-raysystem, indicated for use in:- producing panoramicX-ray images for diagnosticexamination of dentition(teeth), jaws and oralstructures;- producing radiographsof maxillofacial region andparts of the skull forcephalometric examination, ifequipped with CEPH arm;- producing radiographs ofhands and wrists for carpusexamination, if equipped withCEPH arm;	same

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Characteristic	Predicate	Proposed	ChangeId
	X-MIND trium	X-MIND trium
	- producing tomographicimages of the oral andmaxillofacial region, fordiagnostic examination ofdentition (teeth), jaws, oralstructures and some cranialbones, if equipped with CBCToption.	- producing tomographicimages of the oral andmaxillofacial region, fordiagnostic examination ofdentition (teeth), jaws, oralstructures and some cranialbones, if equipped with CBCToption.
Performancespecifications	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 withimproved orthogonality	- sectorial panoramic withimproved 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	ChangeId
	X-MIND trium	X-MIND trium
	3) CBCT:- full view- extended view	3) CBCT:- full view- extended view
Type of powersupply	Single-phase alternatingcurrent power supply	Single-phase alternatingcurrent power supply	same
Nominal voltage	100 V - 240V	100 V - 240V	same
Maximum voltagevariation	±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 withintermittent X-ray loading	Continuous operation withintermittent X-ray loading	same
Protection againstelectrical shock	Class I	Class I	same
Degree ofprotection againstelectrical shock	Type B	Type B	same
Emission	Group 1, Class A	Group 1, Class A	same
Manufacturer ofthe X-ray tube	Skan X	Skan X	same
X-ray tube model	CEI OPX/105	CEI OPX/105	same
Nominal HighVoltage	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	ChangeId
	X-MIND trium	X-MIND trium
	80 - 90 kV for CBCT	80 - 90 kV for CBCT
Anode heatstorage capacity	30 kJ	30 kJ	same
Nominal focal spotdiameter	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 85kV	2.8 mm Al for PAN/CEPH at 85kV	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 85kV	3.4 mm Al for PAN/CEPH at 85kV	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 timeseconds	Seconds ± (5% + 50ms)	Seconds ± (5% + 50ms)	same
Detectortechnology	CMOS	CMOS	same
Detectormanufacturer	Hamamatsu	Hamamatsu	same

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Characteristic	Predicate	Proposed	ChangeId
	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

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Proposed

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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 exposuretime	PAN: 16.8 s	PAN: 16.8 s	1
	CEPH:18 s	CEPH:18 s	2
Detectortechnology	Flat panel CMOS	Flat panel CMOS	same
Detectormanufacturer	Hamamatsu	Hamamatsu	same
Detector model	C12280D-40	C12903D-40G	3
Image voxel size	75 µm (minimum slicethickness)	75 µm (minimum slicethickness)	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
Detectorresolution²:	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	ChangeId
	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 realexposure time	6s (Normal quality)7.2s (Medium quality)9s (High quality)	6s (Normal quality)7.2s (Medium quality)9s (High quality)	same
Source ImageDistance (SID)	PAN: 550mmCBCT: 633mm	PAN: 550mm (adult)PAN: 490mm (special smallchild)CBCT: 610 (adult)CBCT: 588 (special small child)	4
Protocol types(CBCT exams only)	Standard Dose protocols	Standard Dose protocolsLow Dose (LD) protocols	7
Dimensions	Footprint:PAN/CBCT: max 1100 mm x1505 mmWith CEPH: max 1715 mm x1500 mmHeight: 2350 mm	Footprint:PAN/CBCT: max 1100 mm x1505 mmWith CEPH: max 1715 mm x1500 mmHeight: 2350 mm	same
Weight	PAN: 230 kgPAN/CBCT: 240 kgPAN/CBCT With CEPH: 280 kg	Wall mount:PAN: 230 kgPAN/CBCT: 240 kgPAN/CBCT With CEPH: 280 kgSelf standing:PAN: kg 280	6

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Characteristic	Predicate	Proposed	ChangeId
	X-MIND trium	X-MIND trium
		PAN/CBCT: kg 290
		PAN/CBCT With CEPH: kg 330
Mechanicalconfiguration	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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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 trium2D analysis + AIS 3D app	X-MIND trium2D 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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Pseudocolouranalysis 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 imagevisualizationfeatures	+ Zoom and pan+ Rotation+ Flipping / mirroring, vertical / horizontal	+ Zoom and pan+ Rotation+ Flipping / mirroring, vertical / horizontal	same
Measuringfunction	+ 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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	+ Median filter+ SHARP filter: denoiser andedge enhancer+ STAR filter: streak and metalartifacts reduction	+ Median filter+ SHARP filter:denoiser and edgeenhancer+ STAR filter: streakand metal artifactsreduction
Multi PlanarReconstruction(MPR)	+ Axial plane+ Coronal plane+ Sagittal plane	+ Axial plane+ Coronal plane+ Sagittal plane	same
Oblique MPR	Included	Included	same
Single and multiplecross sectionsvisualization	Included+ Setting number of sections+ Setting distance of sections	Included+ Setting number ofsections+ Setting distance ofsections	same
Windowing	+ Contrast-brightness set+ Lower-Upper level+ Editing preset	+ Contrast-brightnessset+ Lower-Upper level+ Editing preset	same
Display mode	+ MPR (voxel intensity)+ Ray Sum+ Maximum intensityprojection (MIP)+ Minimum intensity projection(minMIP)+ SCOUT	+ MPR (voxelintensity)+ Ray Sum+ Maximum intensityprojection (MIP)+ Minimum intensityprojection (minMIP)	same

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• Volume thickness selection

(for MIP and Ray Sum)

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• SCOUT

• Volume thickness selection (for MIP and

002_k Summary

		Selection (for MIP and Ray Sum)
3D volumerendering	+ Preset template+ Editing of user-definedtemplate	+ Preset template+ Editing of user-defined template	same
Surface Rendering	+ Surface generation+ STL export	+ Surface generation+ STL export	same
Curve PlanarReformation (CPR)for dental analysis	+ Dentascan wizard	+ Dentascan wizard	same
Advanced 3Dvisualization tools	+ 3D clipping: 3D cut byorthogonal planes+ 3D thin slab rendering+ 3D sculpting: 3D cut by user-defined planes+ 3D flying mode: 3D virtualendoscopy	+ 3D clipping: 3D cutby orthogonal planes+ 3D thin slabrendering+ 3D sculpting: 3D cutby user-definedplanes+ 3D flying mode: 3Dvirtual endoscopy	same
Advanced 3Dfunctions	+ Implant planning wizard+ Nerve tracing+ Importing 3D STL object inpatient volume+ STL implant library+ Measuring bone density atimplant sites	+ Implant planningwizard+ Nerve tracing+ Importing 3D STLobject in patientvolume+ STL implant library	same

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• 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)
• 2. 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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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
1	New PAN detector	21A. IonisingradiationhazardHarm:biologicaleffects dueto X-rayionisingradiation duetoevent 4)Unwantedx-rayexposuredue to poorimagequality(inadequatefordiagnosticpurpose)	Guidance for theSubmission of510(k)'s for SolidState X-rayImaging Devices"	Same technologyDQE values for newdetector are in therange ±0.1 on thewhole frequencyrange (1 – 4 LP/mm)	SamePASS
2	New CEPH detector	21A. IonisingradiationhazardHarm:biologicaleffects dueto X-rayionisingradiation dueto event 4)	Guidance for theSubmission of510(k)'s for SolidState X-rayImaging Devices"	Same technologyDQE values for newdetector are in therange ±0.1 on thewhole frequencyrange (1 – 4 LP/mm)	SamePASS

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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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
		Unwanted x-ray exposuredue to poor image quality(inadequate fordiagnostic purpose)
3	NewPAN-CBCTdetector	21A. Ionisingradiation hazardHarm:biological effects dueto X-rayionisingradiation duetoevent 4)Unwantedx-rayexposuredue to poorimagequality(inadequatefordiagnosticpurpose)	Bench testaccording to sameprotocol used in X-MIND triumSubmissionK160166	Same or superiortrade-off betweendose and imagequality (i.e. SystemIndicator (SI) in CBCT)$S_{DAP} \ge S_{DAP ; predicate}$$S_{DAP} = \frac{CNR}{DAP \cdot (\frac{1}{2 \cdot V_{50%}})^2}$CNR is the contrast tonoise ratio (overagedvalue from 5measurements)DAP is the dose areaproduct declared in IFUV50% is the resolutionindicator at 50%modulation	WomanMediumStandardqualityFOV80X80-80X90$S_{DAP} ; TLD =$> SDAPpredPASSWomanMediumStandardqualityFOV110X80$S_{DAP} ; TLD >$PASSChildmedium

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
					Standardd quality
					FOV80X80-80X90
					SID Adult
					SDAP TLD >SDAP pred
					PASS
					ChildmediumStandardd quality
					FOV80X80-80X90
					SID Child
					SDAP TLD >SDAP pred
					PASS
			Voxel Noise [a.u.] withTLD cassette includingnew PAN-CBCT sensor(VNTLD) ≤ Voxel Noise[a.u.] predicate (VN)		WomanMediumStandardqualityFOV
					80X90-

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
					VNTLD < VN
					PASS
					WomanMediumStandardquality
					FOV110X80
					VNTLD < VN
					PASS
					ChildmediumStandardd quality
					FOV80X80-80X90
					SID Adult
					VNTLD < VN
					PASSChildmediumStandardd quality

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summary of results
				NPS0D [a.u.²] with TLD cassette including new PAN-CBCT sensor ≤ NPS0D [a.u.²] pedicate	FOV80X80-80X90SID ChildVNTLD <VNPASSWomanMediumStandardquality
					FOV80X90-NPS0D TLD< NPS0DPASSWomanMediumStandardquality
					FOV110X80NPS0D TLD< NPS0DPASSChildmedium

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results
					Standardd quality
					FOV80X80-80X90
					SID Adult
					NPSOD TLD< NPSOD
					PASSChildmedium
					Standardd quality
					FOV80X80-80X90
					SID child
					NPSOD TLD< NPSOD
					PASS
			IEC 60601-2-63203.8.5.3Correspondence	c) along each of thetwo axes of the IMAGERECEPTION AREA, the	SID Adultedge≤ 20mmPASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summary of results
			between X-RAY FIELD and EFFECTIVE IMAGE RECEPTION AREA (rectangular area)	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; d) the sum of the discrepancies on both axes shall not exceed 3 cm or 4 % of the indicated FOCAL SPOT TO IMAGE RECEPTOR DISTANCE, whichever the larger	Sid Child edge ≤ 20mm PASS< 30mm PASS

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				e) along the axis of theIMAGE RECEPTIONAREA that is parallel tothe direction of thescanning, the X-RAYFIELD shall not exceedthe EFFECTIVE IMAGERECEPTION more than1 mm on each side.	≤ 1PASS
				f) along the axis of theIMAGE RECEPTIONAREA that isperpendicularto the direction of thescanning the X-RAYFIELD shall not exceedthe EFFECTIVE IMAGERECEPTION AREA	=0PASS
			21 CFR 1020.31 f)4)	field does not exceedeach dimension ofthe image receptor bymore than 2 percentof the SID,	PAN≤ 2%PASSPANreducedSID≤ 2%PASSCBCT≤ 2%PASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
					CBCTreducedSID<2% PASS
				align the center of thex-ray field with thecenter of the imagereceptor to within 2percent of the SID,	Only forPAN andCEPHPASS
	Additionof FOV	No variationin intendeduse	N.A.	N.A.	N.A.
4	Addition ofTLDcassette	New TLDcassette	Mechanical3D. Cuttingor severing,trapping,crushing,impact,instability.2) Fall ofsuspendedand movingmasses	ES60601-1:2005/(R)2012 andA1:2012,	Safety factor ≥2.5	k >>2.5respect tolocalcollapsePASS
	NewChildspecialexam	29AUnintendeduse of thedevice due to	IEC 60601-1-6	The criteria to passusability verificationare that all thecomments arepositive.	PASS

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Id	Device Change		Risks	Verification/Validation Method(s)	Acceptance Criteria		Summaryof results
			humanfactorsEvent 6)Misplaceadultpatientsduring childexamInadequatearrangement ofcontrolsandindicators
	New toolChildspecialexam		4C. Contactallergy duetoInappropriate materials,notbiocompatible	Same material,same plasticinjection processof chin rest, biteblockISO 10993-5: 2009	Cytotoxicity:No cytotoxic		PASS
				ISO 10993-10:2010	Hypersensitivity:Not sensitizing -		PASS
	True Lowdose(TLD)(reduction of SID)		21A. IonisingradiationhazardHarm:biologicaleffects dueto X-ray	Bench test PANmode according tosame protocolused in X-MINDtrium Submission	Absence of artifactsEqual Hight contrastresolution		BothverifiedPASSBoth 3.1lp/mm

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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<52. image CHILD NEDIUM SID 11 quality <predicate (inadequate PASS for Bench test CBCT Same or superior Woman diagnostic mode according to trade-off between Medium purpose) same protocol dose and image Standard used in X-MIND quality (i.e. System quality trium Submission Indicator (SI) in CBCT) FOV 80X80-K160166 SDAP ≥ SDAP predicate 80X90 CNR CNR SDAP =-SDAP TLD > 1 DAP SDAP pred 2.Vzm/ is the contrast to noise PASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
				ratio (overaged valuefrom 5 measurements)DAP is the dose areaproduct declared in IFUV50% is the resolutionindicator at 50%modulation	WomanMediumStandardqualityFOV110X80SDAP TLD >SDAP predPASS
					ChildmediumStandardd qualityFOV80X80-80X90SID AdultSDAP TLD => SDAPpredPASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
					ChildmediumStandardd quality
					FOV80X80-80X90
					SID Child
					SDAP TLD >SDAP predPASS
			Voxel Noise [a.u.] withTLD cassette includingnew PAN-CBCT sensor(VNTLD) ≤ Voxel Noise[a.u.] predicate (VN)		WomanMediumStandardquality
					FOV80X90-
					VNTLD <VN
					PASS
					WomanMediumStandardquality
					FOV110X80
					110X90

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results
					VNTLDVN
					PASS
					ChildmediumStandardd quality
					FOV80X80-80X90
					SID Adult
					VNTLDVN
					PASS
					ChildmediumStandardd quality
					FOV80X80-80X90
					SID ChildVNTLDVN
					PASS
					WomanMedium

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summary of results
				NPS0D [a.u.2] with TLD cassette including new PAN-CBCT sensor ≤ NPS0D [a.u.2] predicate	StandardqualityFOV80X9090X90-NPS0D TLD< NPS0DPASS
					WomanMediumStandardqualityFOV110X80110X90NPS0D TLD< NPS0DPASS
					ChildmediumStandardd qualityFOV80X80-80X90SID Adult

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I	d	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
						NPS0D TLD< NPS0DPASS
						ChildmediumStandardd quality
						FOV80X80-80X90
						SID Child
						NPS0D TLD< NPS0D
						PASS
			Detectabilitystudy	As requested byFDA RAI 23thAugust 2019	Same pathological orclinically relevantconditions identifiableboth in the STDprotocol scan and inthe TLD protocol one	PASSAllpathological orclinicallyrelevantconditionsidentifiedwith STDprotocolscan havebeenidentifies

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results
					the LDprotocoloneNote Pos.45 "wornoutdentalneck" notidentifiednor instandardmode norin TLDconfiguration
	Software(newmovementmanagedbyfirmware)	PEMS 1.6Unintendedmovementof the U-arm, patientsupport,SIDregulationaxis ormobilecolumn/patient	Same protocolusedprotocol used in X-MIND triumSubmissionK160166	All test shall be PASS	All testPASS

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y

Id	Device Change		Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
5	Changeofbeamlimitingdevice	Changeofaperturedimensions	5A Biologicaleffects dueto X-rayionisingradiation.2)UnwantedX-ray due tounsuitableor faultshielding(causingleakageradiation),filtration orcollimation	IEC 60601-2-63203.8.5.3Correspondencebetween X-RAYFIELD andEFFECTIVE IMAGERECEPTION AREA(rectangular area)	c) along each of thetwo axes of the IMAGERECEPTION AREA, theedges of the X-RAYFIELDshall not exceed thecorresponding edgesof the EFFECTIVEIMAGE RECEPTIONAREA bymore than 2 cm or 3 %of the indicated FOCALSPOT TO IMAGERECEPTOR DISTANCEwhenthe IMAGE RECEPTIONPLANE is normal to theX-RAY BEAM AXIS,whichever the larger;	SID Adultedge< 20mmPASSSid Childedge< 20mmPASS
				21 CFR 1020.31 f)4)	field does not exceedeach dimension ofthe image receptor bymore than 2 percentof the SID,	PAN< 2%PASSPANreducedSID< 2%PASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results3
					CBCT< 2%PASS
					CBCTreducedSID< 2%PASS
				align the center of thex-ray field with thecenter of the imagereceptor to within 2percent of the SID,	PASSOnly forPAN andCEPH
			21 CFR 1020.30 (k)	Same geometry as theprevious version	PASS
6	Addition of selfstanding versionself standing base	Hazardoussituations:3D. Cutting	IEC 60601-19.4.2instabilityoverbalance	At 10° in all directionsno overbalance	PASS
		or severing,trapping,crushing,impact,instability.Event (8)Unbalancing of theself-standingdevice dueto basemechanical	9.8.2 tensile safetyfactor	Safety factor ≥ 4	>4 withrespect toyielding(localplasticstrains)>4 withrespect tolocalcollapse

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summary of results
7	The Low Dose functionality	X-ray:AIS 514Biological effects due to X-rayionising radiationEvent 2:Overexposu re of X-ray due to the need of exposure to be repeated due tofault 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)	ManSDAP low dose >SDAP standard protocolPASSWomanSDAP low dose >SDAP standard protocolPASSChildSDAP low dose >SDAP standard protocolPASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summary of results
				$\Delta%VN \le 10%$ $\Delta%VN = \frac{VNld - VNs}{100 + VNsd}$ VNld = Voxel Noise [a.u.] low dose protocolVNsd = Voxel Noise [a.u.] standard protocol	Man$\Delta VN% < 10%$PASSWoman$\Delta VN% < 10%$PASSChild$\Delta VN% < 10%$PASS
				$\Delta%NPS \le 30%$ $\Delta%NPS = \frac{NPSld - NPSsd}{100 + NPSsd}$ NPSld = NPSOD [a.u.2] low dose protocolVPSsd = NPSOD [a.u.2] standard dose protocol	Man$\Delta NPS < 30%$PASSWoman$\Delta NPS < 30%$PASSChild$\Delta NPS < 30%$PASS

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Id	Device Change	Risks	Verification/Validation Method(s)	Acceptance Criteria	Summaryof results
			Detectability studyas requested byFDA RAI 23thAugust 2019	Same pathological orclinically relevantconditions identifiableboth in the STDprotocol scan and inthe LD protocol one	PASSAllpathological orclinicallyrelevantconditions havebeenidentifiedboth inthe STDprotocolscan andin the LDprotocolone

Table 9: change traceability matrix

Details on Risk Management file, verification and validation are available in section 16

PERFORMANCE, SAFETY, EMC TESTS XIV.

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

Electrical safety and electromagnetic compatibility (EMC)

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

The performance tests on X-MIND trium V2 have been conducted by a Nationally Recognized Testing Laboratory (NRTL) in order to verify:

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

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) Summary

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compliance with electromagnetic compatibility requirements. .

The following table illustrates the standards to which X-MIND trium V2 complies, compared to those related to X-MIND trium

Proposed device	Predicate device
X-MIND trium	X-MIND trium
IEC 60601-1 3rd ed.	IEC 60601-1 3.1rd ed.
ANSI/AAMI ES60601-1: 2005	ES60601-1: 2005/(R)2012 and A1:2012
CAN/CSA C22.2 No. 60601-1:08	CAN/CSA C22.2 No. 60601-1:14
IEC 60601-1-2: 2007	IEC 60601-1-2: 2014
IEC 60601-1-3: 2008	IEC 60601-1-3: 2013
IEC 60601-2-63: 2012	IEC 60601-2-63: 2017
IEC 60601-1-6: 2010	IEC 60601-1-6: 2013
IEC 62366: 2007	IEC 62366: 2016
ISO 149714	ISO 14971

Table 10: comparison between the standard applied

All the test reports for X-MIND trium are available in Section 16 of this submission.

X-MIND trium has been tested according to approved verification protocols to assure its conformity to the following parts of USA Code of Federal Regulations 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.
• 21 CFR §1020.33 Computed tomography (CT) equipment.

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Software Verification and Validation Testing

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

Performance testing - Bench

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:

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

The technical bench tests issued to evaluate the performance and safety of the TLD (True Low Dose) cassette, reduced SIDs and the LD (Low Dose) functionality have been integrated by a clinical detectability analysis that provided evidence that the overall diagnostic quality of the CBCT datasets and dental panoramic images obtained by using the TLD functionality is basically the same as the images obtained in standard scan protocols.

The detectability analysis consisted in submitting the radiographs of cadavers to a set of intended users (radiologist, dentist, oral surgeon), who evaluated the visibility of anatomical structures and features of interests in the different scanning conditions.

Based on the bench test results on image quality and radiation dose and on the results of the detectability study 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, confirmed the equivalence of X-MIND trium proposed device to X-MIND trium predicate device.

XV. FDA guidance documents

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

• . FDA Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s August 2005

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FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices . September 2016

• FDA Guideline Use of International Standard ISO 10993-1,"Biological evaluation of medical o devices Part 1: Evaluation and testing June 2016
• . FDA Guideline Recomended Content and format of complete Test reports for NOn-ClinicalBench performance Testing in 510K submission April 2019.
• o 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
• May 2005 .

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• FDA Guidance Content of premarket submission for management of cybersecurity October, . 2014

CONCLUSIONS 1.

Based on a comparison of intended use, indications, construction materials, principal of operation, features, technical data and performances including diagnostic quality of the acquired images,

X-MIND trium including changes listed above is safe and effective to perform its intended use as well as substantially equivalent predicate device X-MIND trium (already cleared version)

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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.