PaX-Zenith3D is a computed tomography x-ray system intended to take panoramic, cross-sectional images of the oral and craniofacial anatomy and provide diagnostic information for children and adults clinical care in dentistry. The device is operated and used by x-ray technicians and dentists including oral surgeons.

Device Description

PaX-Zenith3D is a dual X-ray machine which combines cone beam CT and panoramic X-ray modality to offer high definition digital diagnostic images in multi FOV for dental practitioners. Separately embedded panorama and CT sensors capture 2D and 3D images based on digital and CT technology while the most advanced digital imaging process enables the capture S/W program to provide one of the most effective image analysis and diagnosis in real time.

AI/ML Overview

The provided 510(k) summary (K102196) for the PaX-Zenith3D X-ray system does not detail specific acceptance criteria in the form of a numerical table or an explicit study proving numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Picasso-Duo). This means the primary "acceptance criteria" were that the new device performs similarly enough to the legally marketed predicate device to be considered safe and effective for the stated indications for use.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The document emphasizes substantial equivalence based on similarity rather than on meeting specific quantitative thresholds for clinical performance.

The summary states:

"The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively,"
"The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison."
"Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well."

These statements indicate that the device's performance was compared to the predicate device's performance across metrics like spatial resolution, MTF (Modulation Transfer Function), DQE (Detective Quantum Efficiency), and SNR (Signal-to-Noise Ratio), and found to be "almost identical" or "similar." However, the exact acceptance thresholds for these similarities or the detailed numerical results are not included in this accessible summary.

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

The document does not specify a sample size for a test set for a clinical performance study. The statement "sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well" suggests that a collection of images was used for comparison, but the number of cases or images is not quantified.

Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for any clinical data used for comparison.

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

This information is not provided in the summary. Since the submission relies on substantial equivalence and "similar quality of images" rather than a clinical trial with established ground truth diagnoses, details on expert panel review for ground truth are absent.

4. Adjudication method for the test set

This information is not provided. Given the nature of the submission (substantial equivalence based on technical and image quality similarity), a formal adjudication method for a clinical test set is not described.

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

An MRMC study was not performed according to the summary. This device is an X-ray imaging system, not an AI-powered diagnostic aid. The "performance" being evaluated is the image acquisition capability of the hardware, not the performance of human readers with or without AI assistance.

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

A standalone performance study for an algorithm was not done. This device is hardware (an X-ray system) that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.

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

The document does not describe the use of clinical ground truth (like pathology or outcomes data) in the context of demonstrating substantial equivalence. The comparison heavily relies on technical image quality metrics (spatial resolution, MTF, DQE, SNR) and a subjective assessment of "similar quality of images."

8. The sample size for the training set

This information is not applicable/not provided. This device is an X-ray imaging system and does not employ a machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable/not provided as there is no mention of a machine learning algorithm or a training set.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (understood as demonstrating substantial equivalence) is primarily non-clinical technical testing and a comparison of sample clinical images.

The submission relies on:

Technical performance data: Comparison of spatial resolution (5.0 lp/mm for PaX-Zenith3D vs. 5.2 lp/mm for Picasso-Duo, considering pixel binning), MTF, DQE, and SNR as detailed in the "SSXI Non Clinical Report" (Tabs 25, 26, and 27). The conclusion states these were "similar."
Safety and EMC testing: Adherence to various IEC standards (IEC 60601 series) to ensure electrical, mechanical, and environmental safety, as well as electromagnetic compatibility. "All test results were satisfactory."
DICOM compliance: Meeting NEMA PS 3.1-3.18 standards for Digital Imaging and Communications in Medicine.
Clinical image comparison: "Sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well." This suggests a qualitative comparison of images.

The overall approach is to show that the PaX-Zenith3D performs as well as or comparably to the predicate device across key technical specifications and relevant safety standards, thereby establishing substantial equivalence. There is no mention of a formal clinical trial with defined endpoints, statistical analysis, or ground truth establishment for diagnostic accuracy.

Summary

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K102196

MAR 2 5 2011

510(k) Summary (Revised)

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

Date

November 22, 2010

Manufacturer

VATECH Co., Ltd. 23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do, 445-170, Korea

Tel: +82-31-379-9622 Fax: +82-31-379-9587 Contact person: Mr. Hyuk-jun Choi

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

VATECH America Inc. 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-Zenith3D

Computed Tomography X-ray System Common Name:

Classification Name:

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

Description:

Indication for use:

Vatech Co.,Ltd.

p. 1 of 2

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Predicate Device:

Manufacturer	: E-WOO Technology Co., Ltd.
Device	: Picasso-Duo
	510(k) Number : K090991 (Decision Date - 10/9/2009)

Substantial Equivalence:

PaX-Zenith3D described in this 510(k) has the similar intended use and technical characteristics as the Picasso-Duo of E-WOO Technology Co., Ltd.

The indications for use, material, form factor, performance, and safety characteristics between PaX-Zenith3D and the predicate device are similar. The primary differences are size, cosmetic, structure and component used only. Accordingly we can claim the substantially equivalence of PaX-Zenith3D to the predicate device.

The actual spatial resolution data for a digital panorama image for Xmarul 501CF for PaX-Zenith3D and S7199-01 for Picasso-Duo are almost identical after considering pixel binning of S7199-01. 5.0 lp/mm(Xmaru1501CF) and 5.2 lp/mm(S7199-01), respectively, Further technical details of the pixel binning for S7199-01 is described in the Executive Summary (Tab 10).

The similar technical characteristics of both devices are further described in the SSXI Non Clinical Report (Tap 25, 26, and 27) in terms of MTF, DQE, and SNR comparison. Finally, the sample clinical images for both devices have been included in the Clinical Report (Tab 28) to demonstrate the similar quality of images taken from both devices as well.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (A)+A2, 1995), IEC 606061-1-1(2001), 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 60601-2-44 (Ed.2+A1, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

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

All test results were satisfactory.

PaX-Zenith3D also meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

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-Zenith3D is safe and effective and substantially equivalent to predicate device as described herein.

END

Vatech Co.,Ltd.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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 Parkway, #303 SECAUCUS NJ 07094

MAR 2 5 2511

Re: K102196

Trade/Device Name: PaX-Zenith3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 8, 2010 Received: March 16, 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 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,

Mary Patel

Mary S. Pastel, Sc.D. 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-Zenith3D

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)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Mary Patil

510K.

Division of Radiological Device Division of Haulologicul Device Evaluation and Safety

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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.