PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

Device Description

PreXion3D Excelsior consists of a scanner, which is used for generating X-ray and detecting image data, and a Console, which is used for operating the scanner and managing the data. The scan data acquired by the scanner will be transferred to the Console. PreXion3D Excelsior Image Analysis System will then perform the image analysis (2D/3D) or image edition (creating cross-section diagram, etc.), and output the image to a printer.

During scanning, X-rays are generated from the x-ray tube head mounted in the arm of the scanner and the x-rays passing through a patient are then detected by the flat panel detector of the scanner under the control of the firmware inside and the console software installed on the qualified Computer. The detected x-ray absorption data is processed by the console software to reconstruct the diagnostic images. The PreXion3D Excelsior has three operation modes, CT scan, Panoramic scan and Cephalometric exposure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PreXion3D Excelsior device, a dental Cone-beam Computed Tomography (CT) system. The submission aims to establish substantial equivalence to a predicate device (K161881). The key modification is the addition of a "Complete mode" for CT scans, which simulatively creates a wider Field of View (FOV) by extending the FOV height.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from predicate device criteria)	Reported Device Performance (Modified Device)
Spatial Resolution for CT (3D MTF)	"The assessment of 3D MTF for the subject device was performed to the stitching area of the volume data of Complete mode and confirmed that the results met the predicate device criteria."

Assessment: The document states that the 3D MTF results for the Complete mode met the predicate device criteria, implying that the spatial resolution in the extended FOV is comparable. However, no specific numerical acceptance threshold or performance value for 3D MTF is provided in the document. The general acceptance criteria are implicit: the modified device should perform as well as the predicate device in relevant aspects.

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

The document does not explicitly state the sample size used for the performance testing.

It mentions "the stitching area of the volume data of Complete mode" was assessed, but the number of cases or images is not quantified.
Data Provenance: Not specified. It can be inferred that the testing was performed by the manufacturer, PreXion Corporation, likely in Japan, given their address. There is no information on whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The assessment appears to be a technical measurement (3D MTF) rather than relying on expert radiographic interpretation as ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since the primary performance testing mentioned is a technical measurement (3D MTF), an adjudication method by experts would not be applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on technical equivalence and performance of the device itself, not on human reader performance with or without AI assistance.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing mentioned ("assessment of 3D MTF") is inherently a standalone (algorithm only) evaluation, as it objectively measures image quality characteristics of the device's output without human intervention for interpretation.

7. The Type of Ground Truth Used

The ground truth for the performance testing (3D MTF) appears to be based on technical standards and predicate device criteria for image quality measurements. It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This device is a CT imaging system (hardware and associated software for image reconstruction), not an AI/ML algorithm that typically requires a separate training set. The "software modifications" refer to changes that allow for the expanded FOV and reconstruction, not necessarily a machine learning model that needs a training set for diagnostic tasks.

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

Since there is no mention of a training set for an AI/ML algorithm, this information is not applicable/not provided. The "ground truth" concerning the device's functionality and image reconstruction capabilities would have been established through engineering design, simulations, and empirical testing against known physical phantoms or established imaging standards.

In summary:

This 510(k) submission primarily focuses on demonstrating technical equivalence for a modification to an existing CT device. The performance testing described is a technical assessment of image quality (3D MTF) in the newly introduced "Complete mode" to ensure it meets established (predicate device) criteria. It does not involve diagnostic performance studies with human readers, expert consensus on images, or AI/ML training data.

Summary

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Image /page/0/Picture/0 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

PreXion Corporation % Mr. Katsumi Hayashi Director 1-14-1 Kandasuda-cho Chiyoda-ku, Tokyo 101-0041 JAPAN

January 19, 2018

Re: K173878

Trade/Device Name: PreXion3D Excelsior Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: December 19, 2017 Received: December 21, 2017

Dear Mr. Hayashi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173878

Device Name

PreXion3D Excelsior

Indications for Use (Describe).

Cephalometric imaging also includes the hand wrist to obtain carpus images for growth and maturity assessment.

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."

FORM FDA 3881 (7/17)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

510(k) Number: K173878

Applicant Information

Date Prepared:	Jan. 15th, 2018
Company Name andAddress:	PreXion Corporation1-14-1 Kandasuda-cho, Chiyoda-kuTokyo, 101-0041Japan
Contact Person:	Mr. Katsumi HayashiDirector, Quality Assurance and Regulatory DivisionPhone: +81-3-5297-7551FAX: +81-3-5297-7552Email: hayashi@prexion.co.jp

Device Information

Type of 510(k) Submission	Special
Device Type:	Dental Cone-beam Computed Tomography
Regulation Description:	Computed Tomography X-Ray System
Review Panel:	Radiology
Regulation Number:	21 CFR 892.1750
Product Code:	OAS
Device Class:	II
Device Name:	PreXion3D Excelsior

Predicate Device Information

The legally marketed devices to which substantial equivalence is being claimed are:

510(k) Number:	K161881
Device Type:	Dental Cone-beam Computed Tomography
Regulation Description:	Computed Tomography X-Ray System
Review Panel:	Radiology
Regulation Number:	21 CFR 892.1750
Product Code:	OAS
Device Class:	II
Device Name:	PreXion3D Excelsior

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Device Description

Intended Use/Indications for Use

PreXion3D Excelsior is intended to produce two dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the maxillofacial, and ENT (Ear, Nose and Throat) region at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

Cephalometric imaging also includes the hand and wrist to obtain carpus images for growth and maturity assessment.

Comparison to the Predicate Device

We added a Complete mode of CT Scan to the Predicate Device(K161881). That function simulatively creates a widen FOV. FOV height is extended from 81mm to 130mm. FOV width is same as one of Wide mode in CT Scan.

Device	Predicate Device(K161881)	Modified Device
	PreXion3D Excelsior	PreXion3D Excelsior
IntendedUse/Indications forUse	PreXion3D Excelsior is intended toproduce two dimensional digitalpanoramic and cephalometricimages, and three dimensionaldigital x-ray images of themaxillofacial, and ENT (Ear, Noseand Throat) region at the directionof healthcare professionals asdiagnostic support for adult andpediatric patients.Cephalometric imaging alsoincludes the hand and wrist toobtain carpus images for growthand maturity assessment.	Same
X-rayGene	TubeVoltage60-110KV	Same
Device		Predicate Device(K161881)PreXion3D Excelsior	Modified DevicePreXion3D Excelsior
rationDevice	PulseExposurefunction	Yes	Same
	TubeCurrent	1-6mA	Same
	Focal SpotSize	0.3mm	Same
	Detector	FPD (TFT)	Same
	Pixel Size	125 μm x125μm,125µmx250µm(CT)125 μm x 125µm(Panoramic)140 μm x 140µm (Ceph)	Same
X-rayImageCapturingDevice	PixelNumber	1280x1024 (CT)128x1280 (Panoramic)2112x1754 (Cephalometric)	Same
	Size ofAreaReceivingX-ray	160mm x 128mm (CT)160mm x 12.5mm (Panoramic)295.68 x 245.56mm (Ceph)	Same
	Number ofBits	16bits (CT, Panorama)14bits (Ceph)	Same
	SID/SOD	700mm/ 470mm (CT, Panoramic)1735mm / 1500mm (Ceph)	Same
Scanner	Dimension(WxDxH)	930 mm x 1230 mm x2220 mm (CT, Panoramic)1816 mm x 1230 mm x2220 mm (with Ceph)	Same
	Weight	165 kg (CT, Panoramic)200kg (Ceph)	Same
	Imaging Mode	CT scan, Panoramic scan,Cephalometric radiography	Same
	Panoramic ScanPerformance (ScanTime)	8-16sec	Same
	CephalometricRadiography (Scan	0.5-0.8 sec	Same
Device		Predicate Device(K161881)PreXion3D Excelsior	Modified DevicePreXion3D Excelsior
Time)	CT Scan Performance	Scan Time 5.2-23.6sec	Same
	FOV (Voxel Size)	Diameter 100mm x H81mm(0.100 - 0.200mm)	Diameter 100mm x H81mm(0.100 - 0.200mm)
		Diameter 150mmDiameter 100mm x H50mm(0.100 - 0.200mm)Diameter 50mm x H50mm(0.100 - 0.200mm)	Diameter 150mm x H81 (0.200mm)Diameter 100mm x H50mm(0.100 - 0.200mm)Diameter 50mm x H50mm(0.100 - 0.200mm)Diameter 150mm x H130mm(0.100 - 0.200mm)
Volume Size		512x512x5121024x1024x816	512x512x512512x512x9501024x1024x8161024x1024x1515
Dose Level(CTDIw)		Standard (110KV, 2.4mA, 9.6s)10cm: 2.9mGy5cm: 1.9mGy	Standard (110KV, 2.4mA, 9.6s)10cm: 2.9mGy5cm: 1.9mGy
		Rapid (110KV, 2.4mA, 5.2s)10cm: 0.9mGy5cm: 0.8mGy	Rapid (110KV, 2.4mA, 5.2s)10cm: 0.9mGy5cm: 0.8mGy
		High Definition (110KV, 2.4mA,12.8s)10cm: 4.9mGy5cm: 3.2mGy	High Definition (110KV, 2.4mA,12.8s)10cm: 4.9mGy5cm: 3.2mGy
		Ultra High Definition (110KV,2.4mA, 23.6s)10cm: 8.7mGy5cm: 4.3mGy	Ultra High Definition (110KV,2.4mA, 23.6s)10cm: 8.7mGy5cm: 4.3mGy
		Standard Child (95KV, 1.6mA, 9.6s)10cm: 1.4mGy5cm: 1.0mGy	Standard Child (95KV, 1.6mA, 9.6s)10cm: 1.4mGy5cm: 1.0mGy
		Rapid Child (95KV, 1.6mA, 5.2s)10cm: 0.5mGy5cm: 0.4mGy	Rapid Child (95KV, 1.6mA, 5.2s)10cm: 0.5mGy5cm: 0.4mGy
			Complete(110KV, 2.4mA, 19.2s)15cm: 5.8mGy
			Complete Child(95KV, 1.6mA, 19.2s)
Device	Predicate Device(K161881)PreXion3D Excelsior	Modified DevicePreXion3D Excelsior
		15cm: 2.9mGy
PerformanceStandards	ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 62366IEC 62304IEC 60601-2-63IEC 61223-3-4IEC 61223-3-5IEC 60825-1ISO 14971NEMA PS 3.1 - 3.20ISO 10993-1ISO 10993-5ISO 10993-10	Same

The subject device compares to the legally marketed devices as follows:

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Summary of Performance Testing

Verification/validation testing were performed to support the software modifications. Electrical safety, EMC/EMI testing were not performed because there are not any hardware modifications. The assessment of 3D MTF for the subject device was performed to the stitching area of the volume data of Complete mode and confirmed that the results met the predicate device criteria.

Conclusions

The subject device has the same intended use/Indications for use as the predicate device. The subject and predicate device also almost same such as specifications of X-ray Generation Device, Xray Image Capturing Device and Scanner, Imaging Mode, Panoramic Scan Performance, Cephalometric Radiography, Spatial Resolution and conformance with performance standards.

The subject and predicate device also have differences in technological characteristics, such as FOV (Voxel Size), Volume Size and Dose Level (CTDIw) in CT Scan Performance.

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and performance testing that the subject device is substantially equivalent to the legally marketed device identified in this submission.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

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