PaX-Reve3D Plus is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and craniofacial area for a precise treatment planning in adult and pediatric care . The device is operated and used by physicians, dentists, and x-ray technicians.

Device Description

PaX-Reve3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography for implantation. Specifically designed for dental radiography of the oral and craniofacial anatomy, PaX-Reve3D Plus is equipped with extra-oral x-ray detector, panoramic radiography with an extra-oral x-ray tube, cephalometric radiography and computed tomographic radiography. The computed tomography is a system based on CMOS digital X-ray detector. CMOS CT detector is used to capture scanned images in 3D for obtaining diagnostic information for craniofacial surgery or other treatments. The device can also be operated as the panoramic and cephalometire dental x-ray system based on CMOS X-ray detector.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PaX-Reve3D Plus, based on the provided text:

Important Note: The provided text is a 510(k) summary for a dental computed tomography X-ray system. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and performance metrics against a clinical ground truth as might be found for novel AI devices or efficacy claims. The "performance" discussed here primarily refers to technical specifications and comparison to the predicate, not clinical accuracy or diagnostic improvement.

Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a performance study targeting specific clinical endpoints (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence by comparing technical specifications and intended use of the proposed device (PaX-Reve3D Plus) with a legally marketed predicate device (PaX-Reve3D). The implied "acceptance criteria" is that the new device's performance characteristics are either equivalent or improved compared to the predicate, and that it meets relevant safety and performance standards.

Here's a table summarizing the comparison:

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (PaX-Reve3D Plus)
Intended Use	PaX-Reve3D is a Computed Tomography X-Ray System for real-time image acquisition, advanced digital imaging for efficient diagnosis and information management, real-time sharing of image information on a network, and equipped with a Flat Panel Detector and CT sensor to capture 3D X-ray CT scanned images.	PaX-Reve3D Plus is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral and craniofacial anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and craniofacial area for precise treatment planning in adult and pediatric care. Operated by physicians, dentists, and x-ray technicians. (Identical to predicate's core functionality, with slightly more detailed description of the diagnostic utility).
Performance Spec.	Panoramic, cephalometric and computed tomography (Functionality)	Panoramic, cephalometric and computed tomography
Input Voltage	110V/220V~	110V/230V~ (Slight variation, likely deemed acceptable)
Tube Voltage	40-90kV	50-100 kV (Improved range)
Tube Current	2-10mA	2~10 mA (Equivalent)
Focal Spot Size	0.5mm	0.5 mm (Equivalent)
Exposure Time	0.5s-24s (Various)	0.5-24 s (Various) (Equivalent)
Size of Imaging Volume	14 x 12 cm, 10 x 6 cm, 8 x 6 cm, 5 x 5 cm	15 x 15 cm, 12 x 8 cm, 8 x 6 cm, 5 x 5 cm (Larger options available)
Slice Width	0.1mm min.	0.1mm min. (Equivalent)
Total Filtration	2.8mmAl	2.8mmAl (Equivalent)
Pixel Resolution	CT: 2.5 lp/mm, Panorama: 4.5 lp/mm, Cephalometric: 3.94 lp/mm	CT: 2.5 lp/mm (Equivalent), Panorama: 5 lp/mm (Improved), Cephalometric: 3.94 lp/mm (Equivalent)
Pixel Size	CT: 200 µm, Panorama: 96 µm, Cephalometric: 127 µm	CT: 200 µm (Equivalent), Panorama: 100 µm (Slightly larger, possibly due to different sensor technology or field of view, but deemed acceptable given no stated inferiority in resolution), Cephalometric: 127 µm (Equivalent)
Image Receptor	CT with Flat Panel Detector	CT with Flat Panel Detector (Equivalent, though the proposed device uses a CMOS detector which is described in the "Description" but the table states "Flat Panel Detector" which might broadly cover it or be a slight inconsistency).
Software	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible (Equivalent)
Safety & EMC	Compliance with IEC 60601-1 (A1+A2, 1995), IEC 60601-1-3(Ed.I, 2006), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed.1, 1993), IEC 60601-2-32 (Ed.3, 2007), and IEC 60601-2044 (Ed.2+A1, 2002) and IEC 60601-1-2. Compliance with FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices."	"All test results were satisfactory." (Meets standards)

Study Details (Relevant to 510(k) Substantial Equivalence)

The provided document describes a technical comparison and safety testing rather than a formal clinical performance study as might be conducted for an AI-powered diagnostic device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for diagnostic evaluation. The "test set" for this submission would be the physical device itself and its components, undergoing engineering and safety testing.
- Data Provenance: Not specified for clinical data, as this is not a study assessing diagnostic accuracy on a patient cohort. The non-clinical and performance data refer to engineering and safety bench testing, likely conducted by the manufacturer (Vatech Co., Ltd.) in Korea Republic (manufacturer's location).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This type of submission relies on technical specifications and adherence to international safety and performance standards for medical devices, rather than expert-derived ground truth from interpreting medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical ground truth established for a test set of images requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a new imaging system hardware, not an AI software intended to assist human readers. Thus, no MRMC study or AI assistance effect size was reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical imaging hardware device, not a standalone algorithm. Its "performance" is inherent in its image acquisition capabilities, image quality specifications, and adherence to safety standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" here is compliance with established engineering standards (e.g., IEC 60601 series) and the technical specifications of the predicate device.
The sample size for the training set:
- Not applicable. This device is a hardware system, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning algorithm.

In summary, the provided document demonstrates substantial equivalence by:

Comparing the intended use, technical specifications, and performance characteristics of the PaX-Reve3D Plus to a predicate device (PaX-Reve3D).
Showing that the proposed device is either equivalent or features minor improvements (e.g., larger imaging volume options, wider tube voltage range, slightly higher panoramic resolution) that do not raise new questions of safety or effectiveness.
Confirming compliance with a comprehensive set of international electrical, mechanical, environmental safety, and performance standards (IEC 60601 series) and relevant FDA guidance.

The "study" that proves the device meets the (implied) acceptance criteria is the documentation of these technical comparisons and the results of the aforementioned safety and performance tests.

Summary

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OCT 2 2 2019

510(k) Summary

1402124

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800.

Date

، ﺗ

July 23, 2010

Manufacturer

Vatech Co., Ltd.

23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea Republic

Tel: +82-31-679-2081

Fax: +82-31-379-9587

Contact person: Mr. Choi Hyuk-jun

United States Sales Representative (U.S. Designated agent)

VATECH America. 333 Meadowlands Parkway #303, Secaucus, NJ 07094, USA Tel: +832-623-2099 Fax: +713-464-8880 Contact person: Mr. Dave Kim

Trade/Proprietary Name:

PaX-Reve3D Plus

Common Name:

Dental Computed Tomography X-ray System

Classification Name:

X-ray, Tomography, Computed, Dental (21CFR 892.1750, Product code OAS, Class2)

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Description:

Indication for use:

Predicate Device:

Manufacturer	: E-WOO Technology Co., Ltd.
Device	: PaX-Reve3D
510(k) Number	: K090171 (Decision Date - 4/30/2009)

Substantial Equivalence:

The PaX-Reve3D Plus described in this 510(k) has the same intended use and similar technical characteristics as PaX-Reve3D of E-WOO Technology Co., Ltd.

Characteristic	ProposedVatech Co., Ltd.PaX-Reve3D Plus	PredicateE-WOO Technology Co., Ltd.PaX-Reve3D

510(k) number		K090171
Indicationsfor use	PaX-Reve3D Plus is a computedtomography x-ray system intendedto produce panoramic,cephalometric or cross-sectionalimages of the oral and craniofacialanatomy on a real time basis bycomputer reconstruction of x-rayimage data from the same axialplane taken at different angles. Itprovides diagnostic details of theanatomic structures by acquiring360° rotational image sequences oforal and craniofacial area for aprecise treatment planning in adultand pediatric care . The device isoperated and used by physicians,dentists, and x-ray technicians.	PaX-Reve3D is ComputedTomography X-Ray System.Real time - image acquisition.Especially, advanced digitalimaging process allowsconsiderably efficient diagnosis,all kind of informationmanagement, real-time sharing ofimage information on network.Furthermore PaX-Reve3D isequipped with the Flat PanelDetector, CT sensor to capture a3D X-ray Computed tomographyscanned image.
PerformanceSpecification	Panoramic, cephalometric and computedtomography	Panoramic, cephalometric andcomputed tomography
Input Voltage	110V/230V~	110V/220V~
Tube Voltage	50-100 kV	40-90kV
Tube Current	2~10 mA	2-10mA
Focal Spot Size	0.5 mm	0.5mm
Exposure Time	0.5-24 s (Various)	0.5s-24s (Various)
Size of ImagingVolume	15 x 15 cm12 x 8 cm8 x 6 cm5 x 5 cm	14 x 12 cm10 x 6 cm8 x 6 cm5 x 5 cm
Slice Width	0.1mm min.	0.1mm min.
Total Filtration	2.8mmAl	2.8mmAl
	2.5 lp/mm - CT	2.5 lp/mm - CT
PixelResolution	5 lp/mm -- Panorama	4.5 lp/mm -- Panorama
	3.94 lp/mm - Cephalometric	3.94 lp/mm - Cephalometric
	200 $\mu$ m - CT	200 $\mu$ m - CT
Pixel Size	100 $\mu$ m - Panorama	96 $\mu$ m - Panorama
	127 $\mu$ m - Cephalometric	127 $\mu$ m - Cephalometric

Vatech Co., Ltd.

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510(k) Submission -- PaX-Reve3D Plus

・

Vatech Co., Ltd.

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510(k) Submission - Pax-Reve3D Plus

Image Receptor	CT with Flat Panel Detector	CT with Flat Panel Detector
Chin Rest	Equipped Headrest	Equipped Headrest
PerformanceSpecification	Computed tomography	Computed tomography
Mechanical	Compact design	Compact design
Electrical	LDCP logic circuit	LDCP logic circuit
Software	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
AnatomicalSites	Maxillofacial	Maxillofacial

The indications for use, material, form factor, performance, and safety characteristics between PaX-Reve3D Plus and the predicate device are the same. The primary difference is cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Reve3D Plus to the predicate device.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A1+A2, 1995), IEC 60601-1-3(Ed.I, 2006), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed.1, 1993), IEC 60601-2-32 (Ed.3, 2007), and IEC 60601-2044 (Ed.2+A1, 2002) was performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Vatech Co., Ltd. concludes that PaX-Reve3D Plus is safe and effective and substantially equivalent to predicate device as described herein.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

VATECH Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Consultant VATECH America 333 Meadowlands Paekway, #303 SECAUCUS NJ 07094

DCT 2 2 2010

Re: K102124 Trade/Device Name: Dental Computed tomography X-ray system Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: July 23, 2010 Received: July 29, 2010-

Dear Mr. Kim:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known):

102/24

Device Name: PaX-Reve3D Plus

DCT 2 2 2010

Classification: Dental Computed tomography X-ray system

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)	OIVD
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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K	K102124
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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.