PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral 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 maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.

Device Description

PaX-Flex3D 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 teeth or jaws, PaX-Flex3D 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 of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.

AI/ML Overview

The provided 510(k) summary for PaX-Flex3D does not contain specific acceptance criteria or a dedicated study proving performance against such criteria. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (PaX-Reve3D) based on shared intended use and similar technical characteristics.

Here's a breakdown of the information available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria (e.g., minimum resolution, specific accuracy metrics) or a table comparing device performance against such criteria is provided in the document. The "Performance Specification" section compares the technical specifications of the proposed device to the predicate device.

Characteristic	Proposed PaX-Flex3D Performance	Predicate PaX-Reve3D Performance
Pixel Resolution (CT)	3.3 lp/mm	2.5 lp/mm
Pixel Resolution (Panorama)	5 lp/mm	4.5 lp/mm
Pixel Resolution (Ceph.)	5 lp/mm	3.94 lp/mm
Pixel Size (CT)	150x150 μm / 200x200 μm	200 μm
Pixel Size (Panorama)	100x100 μm	96 μm
Pixel Size (Cephalometric)	100x100 μm	127 μm
Size of Imaging Volume	8 x 5 cm, 5 x 5 cm	14 x 12 cm, 10 x 6 cm, 5 x 5 cm
Slice Width	0.1mm min.	0.1mm min.
Tube Voltage	50-90 kV	40-90kV
Tube Current	4~10 mA	2-10mA
Focal Spot Size	0.5 mm	0.5mm
Exposure Time	9 - 24 s	0.5s-30s (Various)
Total Filtration	2.8mmAl	2.8mmAl

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

The document states that "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." However, it does not provide details on:

The specific sample size (number of images, cases, or patients) used for any such testing.
The data provenance (country of origin, retrospective or prospective nature).

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC study is not mentioned in the document. The submission focuses on device characteristics and regulatory compliance, not comparative effectiveness with human readers.

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

This device is an X-ray imaging system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study (in the context of AI) would not be applicable or expected for this type of submission. The device's performance is inherently tied to image acquisition and reconstruction.

7. The type of ground truth used

As specific performance studies are not detailed, the type of ground truth used is not specified. The primary "ground truth" implied in this 510(k) is the established performance of the predicate device.

8. The sample size for the training set

This device is an imaging system, not an AI model requiring a "training set" in the machine learning sense. Therefore, this information is not applicable and not provided.

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

As there is no "training set" for an AI model, this information is not applicable and not provided.

Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):

The submission primarily relies on design and performance specifications comparison to a legally marketed predicate device (PaX-Reve3D) and adherence to recognized electrical, mechanical, environmental safety, and performance standards, as well as FDA guidance for solid-state X-ray imaging devices.

The key "study" mentioned is the execution of "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices'." However, the details of these considerations, including specific test methodologies, results, or data sets, are not enumerated in this summary. The conclusion states that "All test results were satisfactory," implying that the device met internal or regulatory benchmarks relevant to its classification and intended use, aligning with the predicate device's performance and safety profiles. The mechanism for "proving" acceptance is largely through demonstrating substantial equivalence to an already cleared device and compliance with relevant safety standards.

Summary

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K102259

510(k) Summary

FEB 1 8 2011

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

Date

July 29, 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-Flex3D

Common Name:

Dental Computed Tomography X-ray System

Classification Name:

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

Description:

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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 of teeth for oral surgery or other treatments. The device can also be operated as the panoramic and cephalometirc dental x-ray system based on CMOS X-ray detector.

Indication for use:

PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral 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 maxillofacial area for a precise treatment planning in adult and pediatric dentishy, The device is operated and used by physicians, dentists, and x-ray technicians.

Predicate Device:

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

Substantial Equivalence:

The PaX-Flex3D 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-Flex3D	PredicateE-WOO Technology Co., Ltd.PaX-Reve3D
510(k) number	-	K090171
Indicationsfor use	PaX-Flex3D is a computedtomography x-ray system intended toproduce panoramic,cephalometric or cross-sectionalimages of the oral anatomy on a realtime basis by computerreconstruction of x-ray image datafrom the same axial plane taken atdifferent angles. It providesdiagnostic details of the anatomicstructures by acquiring 360°rotational image sequences of oraland maxillofacial area for a precisetreatment planning in adult andpediatric dentistry. 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	50-90 kV	40-90kV
Tube Current	4~10 mA	2-10mA
Focal Spot Size	0.5 mm	0.5mm
Exposure Time	9 - 24 s	0.5s-30s (Various)
Size of ImagingVolume	8 x 5 cm	14 x 12 cm
	5 x 5 cm	10 x 6 cm
		5x5 cm
Slice Width	0.1mm min.	0.1mm min.
Total Filtration	2.8mmAl	2.8mmAl
	3.3 lp/mm - CT	2.5 lp/mm - CT
PixelResolution	5 lp/mm - Panorama	4.5 lp/mm - Panorama
	5 lp/mm - Cephalometric	3.94 lp/mm - Cephalometric
	150 x 150 μm / 200 x 200 μm - CT	200 μm - CT
Pixel Size	100 x 100 μm - Panorama	96 μm - Panorama
	100 x 100 μm - Cephalometric	127 μm - Cephalometric
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

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510(k) Submission - PaX-Flex3D

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510(k) Submission - PaX-Flex3D

The indications for use, material, form factor, performance, and safety characteristics between PaX-Flex3D and the predicate device are the same. The primary difference is size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Flex3D 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.1, 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-Flex3D is safe and effective and substantially equivalent to predicate device as described herein.

END

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Public Health Service

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

Vatech Co., Ltd. c/o Mr. Dave Kim Medical Device Regulatory Affairs Vatech America 333 Meadowlands Parkway, #303 SECAUCUS NJ 07094

FFB 18 201

Re: K102259

Trade Name: PaX-Flex3D Regulation Number: 21 CFR § 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 11, 2011 Received: February 15, 2011

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 of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (2) 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 Yours.

Mary S Postel

Mary Pastel, ScD. 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):

Device Name: PaX-Flex3D

Classification: Dental Computed tomography X-ray system

Indications for Use:

PaX-Flex3D is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral 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 maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (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)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K102259
510K

Page 1 of 1

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.