PaX-Primo is a digital panoramic dental X-ray imaging system that uses a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral smictures of the patient population targeting men. women and children. The device is operated and used by physicians. dentists and X-ray technologists.

Device Description

PaX-Primo diagnostic equipment is a dental panoramic X-ray system which consists of X-ray generator, X-ray controller, X-ray beam limiting device, image process unit and exposure switch. This device utilizes a high voltage generator to generate X-ray by inputting energy to the anode and the cathode. The X-ray is exposed on the oral maxillofacial area of a patient before reaching CMOS digital sensor. The CMOS sensor converts resulting X-ray into clectrical charge. The clectrical pattern is further converted to voltage and a digital signal which is interpreted by a computer to produce a digital image.

AI/ML Overview

Based on the provided text, the device in question is the Vatech Co., Ltd. PaX-Primo, a digital panoramic dental X-ray imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (PaX-P&P) rather than establishing novel performance criteria through extensive clinical studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present explicit acceptance criteria in the form of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" are the corresponding characteristics of the PaX-Primo, showing them to be "the same" or "similar."

Characteristic	Acceptance Criteria (Predicate Device: PaX-P&P)	Reported Device Performance (Proposed Device: PaX-Primo)	Met/Not Met (Based on "Same" or "Similar" claim)
Indications for Use	Producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. Operated by physicians, dentists, and X-ray technologists.	Producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. Operated by physicians, dentists, and X-ray technologists.	Met (Claimed as "same")
Performance	Panoramic	Panoramic	Met (Claimed as "same")
Power source	110V/230V~, 50/60Hz	110V/230V~, 50/60Hz	Met (Claimed as "same")
X-ray tube	D-051 (Toshiba)	D-051 (Toshiba)	Met (Claimed as "same")
Focal spot size	0.5 mm	0.5 mm	Met (Claimed as "same")
Total filtration	2.8 mm Al	2.8 mm Al	Met (Claimed as "same")
Tube voltage	50 – 80 kVp	50 – 80 kVp	Met (Claimed as "same")
Tube current	2 – 10 mA	2 - 10 mA	Met (Claimed as "same")
Nominal magnification	1.3	1.3	Met (Claimed as "same")
Exposure time	Min. 6.6 sec, Max. 13.2 sec	Min. 6.5 sec, Max. 13.5 sec	Met (Claimed as "similar" in range)
DICOM compatibility	Compatible	Compatible	Met (Claimed as "same")
X-ray beam	Fan beam	Fan beam	Met (Claimed as "same")
Detector Type	CCD	CMOS	Not Directly Comparable (Different technology, but deemed "similar" in overall function for X-ray acquisition)
Pixel size	0.096 mm	0.100 mm	Met (Claimed as "similar" - minor difference)
Active area	146x6 mm	150.4x6 mm	Met (Claimed as "similar" - minor difference)
Safety and EMC	Compliance with IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, and IEC 60601-1-2	All test results were satisfactory.	Met

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily a substantial equivalence comparison to the predicate device, supplemented by non-clinical testing for safety and performance standards.

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

The document does not specify any clinical test set for evaluating the PaX-Primo's performance against specific diagnostic criteria or a ground truth. The acceptance is based on engineering specifications and comparison to the predicate.
The document mentions "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed, but no details on specific clinical data, sample size, or provenance of such data are provided. This typically means the reliance is on the equivalence of technical specifications rather than new clinical trials.

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 as there is no described clinical test set with a ground truth established by experts.

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

This information is not provided as there is no described clinical test set requiring adjudication.

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 conducted and is not mentioned in the provided text. The device is a digital X-ray imaging system, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an X-ray imaging system, not an algorithm, and its output is intended for human interpretation. No standalone algorithm performance is discussed.

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

This information is not provided as there is no described clinical test set with a ground truth. The "ground truth" for the device's acceptability is essentially its technical specifications matching or being equivalent to those of the predicate device, as well as meeting relevant safety standards.

8. The sample size for the training set:

This information is not provided. The device is a hardware imaging system. If any internal calibration or image processing algorithms were developed, details about their training sets are not included here. Given the 2010 submission date, sophisticated deep learning models requiring large training sets were less common for this type of device.

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

This information is not provided as there is no described training set.

Summary

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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

January 18, 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)

E-WOO Technology USA Inc. 256 North Sam Houston Pkwy E. #115, Houston, TX 77060, USA

Tel: +281-598-8124 Fax: +281-598-8150 Contact person: Mr. Dave Kim

Trade/Proprietary Name:

PaX-Primo

Common Name:

Digital X-ray Imaging System

Classification Name:

System, X-ray, Extraoral Source, Digital (21CFR 872.1800, Product code MUH, Class2)

Vatech Co., Ltd.

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Description:

Indication for use:

PaX-Primo is a digital panoramic dental X-ray Imaging system that uses a CMOS detector for real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists and X-ray technologists.

Predicate Device:

Manufacturer	: Vatech Co., Ltd.
Device	: PaX-P&P
510(k) Number	: K073365 (Decision Date - Apr. 8. 2008)

Substantial Equivalence:

The PaX-Primo described in this 510(k) has the same intended use and similar technical characteristics as the PaX-P&P of Vatech Co., Ltd.

Characteristic	ProposedVatech Co., Ltd.PaX-Primo	PredicateVatech Co., Ltd.PaX-P&P
510(k) number	-	K073365
Indications for use	PaX-Primo is a digital panoramicdental X-ray Imaging system that usesa CMOS detector for real time digitalimage acquisition. It is intended forproducing diagnostic X-rayradiographic images of skull, dentition,and oral structures. The device isoperated and used by physicians.	PaX-P&P is a digital x-ray system thatuses a high resolution CCD detector forreal time digital image acquisition.The system allows lower radiation dose,simple use interface, and produces highquality images. It is intended forproducing diagnostic X-rayradiographic images of skull, dentition,

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	dentists and X-ray technologists.	and orla structures. The device isoperated and used by physicians,dentists,a nd x-ray technologist.
PerformanceSpecification	Panoramic	Panoramic
Power source	110V/230V~, 50/60Hz	110V/230V~, 50/60Hz
X-ray tube	D-051 (Toshiba)	D-051 (Toshiba)
Focal spot size	0.5 mm	0.5 mm
Total filtration	2.8 mm Al	2.8 mm Al
Tube voltage	50 – 80 kVp	50 – 80 kVp
Tube current	2 – 10 mA	2 - 10 mA
Nominalmagnification	1.3	1.3
Exposure time	Min. 6.5 secMax. 13.5 sec	Min. 6.6 secMax. 13.2 sec
DICOMcompatibility	Compatible	Compatible
X-ray beam	Fan beam	Fan beam
Pixel size	0.100 mm	0.096 mm
Active area	150.4x6 mm	146x6 mm

The indications for use, material, form factor, performance, and safety characteristics between PaX-Primo 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-Primo to the predicate device.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 was 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" was performed.

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

END

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Image /page/4/Picture/0 description: The image shows a logo with two distinct parts. On the left, there's a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle. To the right of this emblem, the letters "DEP" are printed in a bold, sans-serif font.

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

AUG 2 1 2013

VATECH Co., Ltd. % Mr. Dave Kim Product Compliance Officer E-WOO Technology USA, Inc. 256 North Sam Houston Pkwy E. #115 HOUSTON TX 77060

Re: K100317

Trade/Device Name: System, X-Ray, Extraoral Source, Digital Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: February 3, 2010 Received: February 4, 2010

Dear Mr. Kim:

This letter corrects our substantially equivalent letter of March 24, 2010.

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. Iisting 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):

Device Name: Pax-Primo

Classification: System, X-Ray, Extraoral Source, Digital

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)

Office of In Vitro

510K K10r317

Page 1 of l

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.