PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dentists, dental assistants, x-ray technicians and other professionals who are licensed by the law of the State in which he or she practices to use the device.

Device Description

PaX-Duo3D Plus (PCT-5000), a dental radiographic imaging system, consists of dual image acquisition modes; panorama, and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PaX-Duo3D Plus (PCT-5000) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic 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 dental x-ray system based on CMOS X-ray detector.

AI/ML Overview

The PaX-Duo3D Plus (PCT-5000) device introduces new cone beam CT sensors (Xmaru0712CF, Xmaru1215CF Plus, Xmaru1215CF Master Plus). The study supporting its substantial equivalence to the predicate device, PaX-Duo3D Plus (K102102), focused on demonstrating similar performance characteristics.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and adherence to safety and performance standards, rather than defining specific diagnostic performance acceptance criteria for a novel AI algorithm. The performance of the new sensors is evaluated against the predicate device's established performance through non-clinical and clinical considerations.

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Safety	IEC 60601-1 (A1+A2, 1995)	All test results satisfactory
	IEC 60601-1-1 (2001)	All test results satisfactory
	IEC 60601-1-3 (Ed. 1, 1994)	All test results satisfactory
	IEC 60601-2-7 (1998)	All test results satisfactory
	IEC 60601-2-28 (Ed. 1, 1993)	All test results satisfactory
	IEC 60601-2-32 (Ed. 1, 1994)	All test results satisfactory
	IEC 60601-2-44 (Ed. 2, 2002)	All test results satisfactory
EMC	IEC 60601-1-2	All test results satisfactory
Non-clinical Performance	FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices"	Non-clinical performance report provided; considered similar to predicate.
Clinical Performance	FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices"	Clinical consideration report provided; considered similar to predicate.
Image Quality / Acceptance Testing	IEC 61223-3-4	All test results satisfactory
	IEC 61223-3-5	All test results satisfactory
Interoperability	NEMA PS 3.1-3.18, DICOM Set	Meets provisions

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

The document mentions "nonclinical and clinical consideration" and an "expert review of image comparisons" for both devices. However, no specific sample size for a test set (e.g., number of patients or images) is explicitly stated. The data provenance (country of origin, retrospective or prospective) is also not specified.

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

The text refers to an "expert review of image comparisons." However, the number of experts used is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience") provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The adjudication method used for the "expert review of image comparisons" is not explicitly stated.

5. 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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described for the device. The study primarily focuses on demonstrating substantial equivalence of the new hardware through technical specifications and expert review, not on AI-assisted diagnostic improvement. Therefore, no effect size for human reader improvement with AI assistance is reported.

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 algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply in this context. The performance described relates to the image acquisition capabilities of the hardware.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "expert review of image comparisons" mentioned, the ground truth was based on expert review/consensus comparing images from the new device with those from the predicate device. The document does not mention pathology or outcomes data for this comparison.

8. The sample size for the training set:

As this is a hardware device submission and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned in the document.

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

Since there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not applicable or described.

In summary, the provided document is a 510(k) summary for a dental X-ray imaging system. The study described focuses on demonstrating the device's adherence to safety and performance standards and its substantial equivalence to a predicate device through non-clinical testing and an expert review of image comparisons, rather than evaluating the diagnostic performance of an AI-powered system with specific acceptance criteria related to disease detection or measurement.

Summary

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Special 510(k) Summary

MAY 2 4 2012

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

Date

4/18/2012

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-Duo3D Plus (PCT-5000)

Common Name:

Computed Tomography X-ray System

Classification Name:

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

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Description:

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 dental x-ray system based on CMOS X-ray detector.

Indication for use:

PaX-Duo3D Plus is a computed tomography x-ray system intended to take panoramic and cross-sectional images of the oral and craniofacial anatomy to provide diagnostic information for adult and pediatric patients. The device is operated and used by physicians, dental assistants, x-ray technicians and other professionals who are licensed by the State in which he or she practices to use the device.

Predicate Device:

Manufacturer	: Vatech Co., Ltd
Device	: PaX-Duo3D Plus
510(k) Number	: K102102 (Decision Date - 3/11/2011)

Substantial Equivalence:

PaX-Duo3D Plus (PCT-5000) described in this 510(k) has the similar intended use and technical characteristics as PaX-Duo3D Plus of Vatech Co., Ltd.

Characteristic	ProposedVatech Co., Ltd.PaX-Duo3D Plus(PCT-5000)	PredicateVatech Co., Ltd.PaX-Duo3D Plus
510(k) number		K102102
Indicationsfor use	PaX-Duo3D Plus is a computedtomography x-ray system intended totake panoramic and cross-sectionalimages of the oral and craniofacialanatomy to provide diagnosticinformation for adult and pediatricpatients. The device is operated andused by physicians, dentists, dentalassistants, x-ray technicians and otherprofessionals who are licensed by thelaw of the State in which he or shepractices to use the device.	PaX-Duo3D Plus is a computedtomography x-ray system intendedto take panoramic and cross-sectional images of the oral andcraniofacial anatomy to providediagnostic information for adultand pediatric patients. The deviceis operated and used by physicians,dentists, dental assistants, x-raytechnicians and other professionalswho are licensed by the law of theState in which he or she practicesto use the device.
Performance	Panoramic and computed	Panoramic and computed
Specification	tomography (CBCT)	tomography (CBCT)
Input Voltage	AC 100-120 / 200-240 V	AC 110 / 230 V ~
Tube Voltage	50-90 kV	50-90 kV
Tube Current	2-10 mA	2-10 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	Max 20.2 s	6.8 - 24 s
Total Filtration	2.8 mmAl	2.8 mm Al
Size of ImagingVolume	CT (Xmaru0712CF): 5 x 5 cm / 8 x 5 cm / 8 x 8 cmCT (Xmaru1215CF Plus): 5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm / 12 x 8.5 cmCT(Xmaru1215CFMasterPlus): 5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm / 12 x 8.5 cmCT(Xmaru1524CF) :5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm / 12 x 8.5 cm	CT(Xmaru1524CF) :5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm /12 x 8.5 cm
	Panoramic(Xmaru1501CF) : 5.0 lp/mm	Panoramic(Xmaru1501CF) : 5.0 lp/mm
	CT (Xmaru0712CF): 3.5 lp/mm
Pixel Resolution	CT (Xmaru1215CF Plus): 3.5 lp/mm
	CT(Xmaru1215CF MasterPlus): 10.1 lp/mm- full resolution5.0 lp/mm -2x2 binning2.5 lp/mm-4x4 binning	CT (Xmaru1524CF) : 2.5 lp/mm




	CT(Xmaru1524CF) : 2.5 lp/mm
	Panoramic(Xmaru1501CF): 100 μm	Panoramic(Xmaru1501CF): 100 μm
	CT (Xmaru0712CF): 140 μm
	CT (Xmaru1215CF Plus): 140 μm
Pixel Size	CT(Xmaru1215CF MasterPlus): 49.5 μm-full resolution99 μm-2x2 binning198 μm-4x4 binning	CT (Xmaru1524CF) : 200 μm



	CT(Xmaru1524CF): 200 μm
	CMOS photodiode array –
	panoramic (Xmaru1501CF) &CT(Xmaru0712CF,Xmaru1215CF Plus,Xmaru1215CF Master Plus,Xmaru1524CF)	CT (Xmaru1524CF) with FlatPanel Detector
Image Receptor

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510(k) Submission – PaX-Duo3D Plus (PCT-5000)

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Indications for use, safety characteristics, and non-clinical performance for panoramic and CBCT sensors of PaX-Duo3D Plus (PCT-5000) and PaX-Duo3D Plus are similar. The primary differences are as follows: PaX-Duo3D Plus (PCT-5000) introduces three new cone beam CT sensors: Xmaru0712CF, Xmaru1215CF Plus. Xmaru1215CF Master Plus. The non-clinical performance and clinical consideration report for the new SSXI CBCT sensors are provided separately in this submission. Based on the nonclinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new PaX-Duo3D Plus (PCT-5000) is substantially equivalent, in terms of safety and effectiveness, with PaX-Duo3D Plus, 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-Duo3D Plus (PCT-5000) 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

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the information provided in this premarket notification. Vatech Co., Ltd. concludes that PaX-Duo3D Plus (PCT-5000) is safe and effective and substantially equivalent to predicate device as described herein.

END

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wing feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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 Affairs Mtech Group 12946 Kimberly Lane HOUSTO TX 77079

MAY 2 4 2012

Re: K121236

Trade/Device Name: PaX-Duo3D Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 18, 2012-Received: April 24, 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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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 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

Enclosure

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Indications for Use

510(K) Number (if known): K12J236

Device Name: PaX-Duo3D Plus

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 néededi

Arul D'A

Office of In

510K K121236

Concurrence of CDRH, Office of Device Evaluation(ODE)

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.