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 (PHT-7000), a dental radiographic imaging system, consists of dual image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Flex3D (PHT-7000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the PaX-Flex3D (PHT-7000) based on the provided 510(k) summary.

1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria as pass/fail thresholds for clinical outcomes. Instead, it lists the technical and imaging specifications of the proposed device and compares them to the predicate device. The "reported device performance" is implicitly that the new device meets or is comparable to these specifications, as a conclusion of substantial equivalence is made.

Characteristic	Acceptance Criteria (Predicate Device K102259)	Reported Device Performance (PaX-Flex3D (PHT-7000))
Indications for Use	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. Provides diagnostic details of anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for precise treatment planning in adult and pediatric dentistry. Operated and used by physicians, dentists, and x-ray technicians.	Identical to Predicate
Performance Specification	Panoramic, cephalometric and computed tomography	Panoramic, cephalometric and computed tomography
Input Voltage	AC 110/230 V	AC 100-120/200-240 V
Tube Voltage	50-90 kV	50-90 kV
Tube Current	4 ~ 10 mA	2 ~ 10 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	9 - 24 s	1.9 - 24 s
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	2.8 mmAl	2.8 mmAl
Mechanical	Compact design	Compact design
Electrical	LDCP logic circuit	LDCP logic circuit
Software	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Anatomical Sites	Maxillofacial	Maxillofacial
Image Receptor (CBCT)	Xmaru0808CF	Xmaru0712CF, Xmaru1215CF Plus (new sensors)
Image Receptor (Panoramic)	Xmaru1501CF	Xmaru1501CF
Image Receptor (Cephalo)	Xmaru2301CF	Xmaru2301CF
Size of Imaging Volume (Xmaru0808CF)	5 x 5 cm / 8 x 5 cm	N/A (predicate only)
Size of Imaging Volume (Xmaru0712CF)	N/A (proposed only)	5 x 5 cm / 8 x 5 cm / 8 x 8 cm
Size of Imaging Volume (Xmaru1215CF Plus)	N/A (proposed only)	5 x 5 cm / 8 x 5 cm / 8.5 x 8.5 cm / 12 x 8.5 cm
Pixel Resolution (CT, Xmaru0808CF)	3 lp/mm	N/A (predicate only)
Pixel Resolution (CT, Xmaru0712CF & Xmaru1215CF Plus)	N/A (proposed only)	3.5 lp/mm
Pixel Resolution (Pano, Xmaru1501CF)	5 lp/mm	5 lp/mm
Pixel Resolution (Ceph, Xmaru2301CF)	5 lp/mm	5 lp/mm
Pixel Size (CT, Xmaru0808CF)	150 x 150 μm	N/A (predicate only)
Pixel Size (CT, Xmaru0712CF & Xmaru1215CF Plus)	N/A (proposed only)	140 x 140 μm
Pixel Size (Pano, Xmaru1501CF)	100 x 100 μm	100 x 100 μm
Pixel Size (Ceph, Xmaru2301CF)	100 x 100 μm	100 x 100 μm

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

The document mentions "an expert review of image comparisons" but does not specify the sample size (number of images or cases) used for this "clinical consideration" or "image comparison" part of the evaluation. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for this image comparison.

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

The document states "an expert review of image comparisons." It does not specify the number of experts involved or their specific qualifications (e.g., radiologist with X years of experience).

4. Adjudication Method for the Test Set:

The document mentions "an expert review" but does not specify any adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence primarily through technical specifications and an "expert review of image comparisons" between the new device and its predicate. There is no mention of human readers improving with or without AI assistance, as the device itself is an imaging system, not an AI-powered diagnostic tool.

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

This section is not applicable as the device is an X-ray imaging system (hardware and associated software for reconstruction and viewing), not an AI algorithm. Its "performance" is its ability to produce diagnostic images.

7. The Type of Ground Truth Used:

For the "expert review of image comparisons," the ground truth was expert consensus (an "expert review" concluding that images from both devices were substantially equivalent in terms of safety and effectiveness).

8. The Sample Size for the Training Set:

This information is not applicable. The device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense for performance evaluation in a 510(k) submission like this. The design and engineering of the device are based on established physics and medical imaging principles.

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

This information is not applicable for the reasons stated in point 8.

Summary

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K121412

Special 510(k) Summary

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

Date

5/2/2012

Manufacturer

Vatech Co., Ltd.

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

Tel: +82-31-379-9585 Fax: +82-31-379-9638 Contact person: Mr. Sonny Park

Official Correspondent (U.S. Designated agent)

Mtech Group

12946 Kimberley Ln, Houston, TX 77079

Tel: +713-467-2607

Fax: +713-464-8880

Contact person: Mr. Dave Kim (davekim@mtech-inc.net)

Trade/Proprietary Name:

PaX-Flex3D (PHT-7000)

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	: Vatech Co., Ltd
Device	: PaX-Flex-3D
510(k) Number	: K102259 (Decision Date – 2/18/2011)

Substantial Equivalence:

PaX-Flex3D (PHT-7000) described in this 510(k) has the similar intended use and technical characteristics as PaX-Flex3D of Vatech Co., Ltd.

Characteristic	ProposedVatech Co., Ltd.PaX-Flex3D (PHT-7000)	PredicateVatech Co., Ltd.PaX-Flex3D
----------------	-------------------------------------------------------	---------------------------------------------

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510(k) Submission – PaX-Flex3D (PHT-7000)

510(k) number	K121412	K102259
Indicationsfor use	PaX-Flex3D is a computedtomography x-ray system intendedto produce 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-Flex3D is a computedtomography x-ray systemintended to produce panoramic,cephalometric or cross-sectionalimages of the oral anatomy on areal time basis by computerreconstruction of x-ray imagedata from the same axial planetaken at different angles. Itprovides diagnostic details of theanatomic structures by acquiring360° rotational image sequencesof oral and maxillofacial area fora precise treatment planning inadult and pediatric dentistry. Thedevice is operated and used byphysicians, dentists, and x-raytechnicians.
PerformanceSpecification	Panoramic, cephalometric and computedtomography	Panoramic, cephalometric andcomputed tomography
Input Voltage	AC 100-120/200-240 V	AC 110/230 V
Tube Voltage	50-90 kV	50-90 kV
Tube Current	$2 \sim 10$ mA	$4 \sim 10$ mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	$1.9 - 24$ s	$9 - 24$ s
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	2.8 mmAl	2.8 mmAl
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
Image Receptor	ComputedTomography(Flat Panel Detector)Xmaru0712CFXmaru1215CF Plus	Xmaru0808CF

Vatech Co., Ltd.

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510(k) Submission – PaX-Flex3D (PHT-7000)

		Panoramic(CMOS photodiodearray)	Xmaru1501CF	Xmaru1501CF
		CephaloMetric(CMOS photodiodearray)	Xmaru2301CF	Xmaru2301CF
Size of ImagingVolume		Xmaru0712CF	5 x 5 cm / 8 x 5 cm / 8 x 8 cm	-
		Xmaru1215CF Plus	5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm / 12 x 8.5 cm	-
		Xmaru0808CF	-	5 x 5 cm / 8 x 5 cm
PixelResolution	CT	Xmaru0712CF	3.5 lp/mm	-
	CT	Xmaru1215CF Plus	3.5 lp/mm	-
		Xmaru0808CF	-	3 lp/mm
	Pano	Xmaru1501CF	5 lp/mm	5 lp/mm
	Ceph	Xmaru2301CF	5 lp/mm	5 lp/mm
Pixel Size		Xmaru0712CF	140 x 140 μm	-
	CT	Xmaru1215CFPlus	140 x 140 μm	-
		Xmaru0808CF	-	150 x 150 μm
	Pano	Xmaru1501CF	100 x 100 μm	100 x 100 μm
	Ceph	Xmaru2301CF	100 x 100 μm	100 x 100 μm

Indications for use, safety characteristics, and non-clinical performance for panoramic, cephalometric and CBCT sensors of PaX-Flex3D (PHT-7000) and PaX-Flex3D are similar. The primary differences are as follows: PaX-Flex3D (PHT-7000) introduces two new cone beam CT sensors:

Vatech Co., Ltd.

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510(k) Submission - PaX-Flex3D (PHT-7000)

Xmaru0712CF and Xmaru1215CF Plus. The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Flex3D (PHT-7000) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D, 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 60601-1-1 (2001), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

PaX-Flex3D (PHT-7000) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

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

Acceptance test according to IEC 61223-3-4 and IEC 61223-3-5 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 (PHT-7000) is safe and effective and substantially equivalent to predicate device as described herein.

END

Vatech Co., Ltd.

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

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 Official correspondent (U.S. designated agent) Mtech group 12946 Kimberly Lane HOUSTON TX 77079

JUN - 8 2012

Re: K121412

Trade/Device Name: PaX-Flex3D (PHT-7000) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 11, 2012 Received: May 11, 2012

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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Enclosure

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 requirences as 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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(K) Number (if known):

Device Name: PaX-Flex3D (PHT-7000)

Classification: Computed tomography X-ray system

Indications for Use:

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)

(Division Sign-Off)

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

510K

Concurrence of CDRH, Office of Device Evaluation(ODE)

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.