PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.

Device Description

PCH-2500 (PaX-i) is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws, PCH-(PaX-i) can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), one cephalometric scan type (Xmaru2301CF) and two flat panel one shot ceph sensors (1210SGA and 910SGA). PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the new component (910SGA sensor) as this is a Special 510(k) submission primarily addressing changes to an existing device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a Special 510(k) for PCH-2500 (PaX-i), primarily introducing a new cephalometric sensor (910SGA). The acceptance criteria for this sensor are implicitly set by its equivalence to the predicate device and the performance of other sensors within the PCH-2500 (PaX-i) system, as well as general performance standards for dental X-ray imaging.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate/Standards)	Reported Device Performance (PCH-2500 (PaX-i) with 910SGA)
Technical Specifications
Pixel Resolution	≥ 3.9 lp/mm (matching 1210SGA predicate sensor)	3.9 lp/mm
Pixel Size	127 x 127 μm (matching 1210SGA predicate sensor)	127 x 127 μm
Image Receptor Type	Amorphous silicon TFT with scintillator (matching 1210SGA)	Amorphous silicon TFT with scintillator
Safety	Compliance with IEC 60601-1 and related standards	All test results were satisfactory
EMC	Compliance with IEC 60601-1-2	All test results were satisfactory
Performance	Compliance with IEC 61223-3-4 and IEC 61223-3-5	All test results were satisfactory
Image Quality	Image quality comparable to predicate device (K113672) for diagnostic information of oral and maxillofacial anatomy	Expert review of image comparisons showed substantial equivalence to predicate device.
DICOM Conformance	Compliance with NEMA PS 3.1-3.18 (DICOM Set)	Meets the provisions of NEMA PS 3.1-3.18
Non-clinical Performance	Satisfactory performance according to FDA Guidance for Solid State X-ray Imaging Devices	Performed and satisfactory
Clinical Considerations	Satisfactory considerations according to FDA Guidance for Solid State X-ray Imaging Devices	Performed and satisfactory

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

The document does not explicitly state the numerical sample size for the "test set" (i.e., the images used for the expert review). It only mentions "image comparisons for both devices." The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified for the images used in the expert review.

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

The document states an "expert review of image comparisons" was conducted, but it does not specify the number of experts used or their qualifications.

4. Adjudication Method for the Test Set

The document mentions an "expert review," but it does not describe an adjudication method (e.g., 2+1, 3+1). It implies a consensus or comparison against a standard, but no specific method is outlined.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, the document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The evaluation primarily focused on demonstrating substantial equivalence to a predicate device through technical specifications, safety/EMC testing, and an expert review of image comparisons. There is no mention of human readers improving with AI assistance, as this is an imaging device, not an AI-assisted diagnostic tool.

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

This question is not directly applicable in the context of this submission. The device is an X-ray imaging system, not an algorithm. Its performance is evaluated as an imaging system, which inherently produces images for human interpretation. The "non-clinical and clinical consideration report for the new SSXI detector, 910SGA" would assess the detector's capability to produce diagnostic images, effectively acting as its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the "image comparisons" was established through expert review. This implies a comparison of diagnostic quality and features between images produced by the new 910SGA sensor and the predicate device's sensors. The ultimate "ground truth" for dental X-ray images is typically the clinical diagnosis or assessment derived by a qualified professional from those images.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a hardware submission, not a machine learning algorithm submission, so a traditional "training set" as understood in AI/ML is not applicable.

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

Since there is no training set mentioned, this question is not applicable.

Summary

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K122/55

Special 510(k) Summary

SEP 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

7/13/2012

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. Sung-Hee Park

Official Correspondent (U.S. Designated agent)

Dave Kim / 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:

PCH-2500 (PaX-i)

Common Name:

Digital X-ray Imaging System

Classification Name:

System, X-Ray, Extra oral Source, Digital (21CFR 872.1800, Product code MUH, class2)

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Description:

PCH-2500 (PaX-i) offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 (PaX-i) imaging mode provides a wide range of imaging options based on the patient diagnostic needs.

Indication for use:

Predicate Device:

Manufacturer	: Vatech Co., Ltd
Device	: PCH-2500
510(k) Number	: K113672 (Decision Date - 3/27/2012)

Substantial Equivalence:

PCH-2500 (PaX-i) described in this special 510(k) submission has the same indications for use and similar technical characteristics as PCH-2500 (K113672) of Vatech Co., Ltd.

Characteristic	ProposedVatech Co., Ltd.PCH-2500 (PaX-i)	PredicateVatech Co., Ltd.PCH-2500
510(k) number	-	K113672, dated on 3/27/2012
Indications	PCH-2500 (PaX-i) is a digital	PCH-2500 is a digital extra

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510(k) Submission -- PaX-i

for use	extra oral source x-ray systemintended to take panoramic andcephalometric images of theoral and maxillofacial anatomyto provide diagnosticinformation for adult andpediatric patients. The deviceshould be operated and used bydentists, x-ray technicians andother professionals licensed bythe law of the state in whichthe device is used.	oral source x-ray systemintended to take panoramic andcephalometric images of theoral and maxillofacial anatomyto provide diagnosticinformation for adult andpediatric patients. The deviceshould be operated and used bydentists, x-ray technicians andother professionals licensed bythe law of the state in whichthe device is used.
PerformanceSpecification	Panoramic and cephalometric	Panoramic and cephalometric
Input Voltage	AC 100-120 / 200-240 V	AC 100-120 / 200-240 V
Tube Voltage	50-90 kV	50-90 kV
Tube Current	4-10 mA	4-10 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	Max 20.2 s	Max 20.2 s
Total Filtration	2.8 mmAl	2.8 mmAl
	Xmaru1501CF panoramicsensor : 5 lp/mm	Xmaru1501CF panoramicsensor : 5 lp/mm
	Xmaru2301CFcephalometric (scan type) :5 lp/mm	Xmaru2301CFcephalometric (scan type) :5 lp/mm
Pixel Resolution	1210SGAcephalometric (one shot type) :3.9 lp/mm	1210SGAcephalometric (one shot type):3.9 lp/mm
	910SGAcephalometric (one shot type) :3.9 lp/mm
Pixel Size	Xmaru1501CF panoramic	Xmaru1501CF panoramic
	sensor : 100 x 100 μm	sensor : 100 x 100 μm
	Xmaru2301CF cephalometric(scan type):	Xmaru2301CF cephalometric(scan type):
	100 x 100 μm	100 x 100 μm
	1210SGAcephalometric (one shot type) :127 x 127 μm	1210SGAcephalometric (one shot type) :127 x 127 μm
	910SGAcephalometric (one shot type) :127 x 127 μm
Image Receptor	CMOS photodiode array –panoramic (Xmaru1501CF) &cephalometric (Xmaru2301CF)	CMOS photodiode array –panoramic (Xmaru1501CF) &cephalometric (Xmaru2301CF)
	Amorphous silicon TFT withscintillator – Cephalometric(1210SGA, 910SGA)	Amorphous silicon TFT withscintillator – Cephalometric(1210SGA)

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510(k) Submission - PaX-i

Indications for use, safety characteristics, and non-clinical performance for panoramic and cephalometric sensors of PCH-2500 (PaX-i) and PCH-2500 are identical. The primary differences are as follows: PCH-2500 (PaX-i) offers a new solid state X-ray sensor for cephalometric mode: 910SGA. The non-clinical performance and clinical consideration report for the new SSXI detector, 910SGA, 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, we can claim the substantial equivalence of PCH-2500 (PaX-i) in comparison with its predicate device, PCH-2500, in terms of safety and effectiveness.

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,

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and IEC 60601-2-32 (Ed. 1, 1994) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

PCH-2500 (PaX-i) also 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 PCH-2500 (PaX-i) is safe and effective and substantially equivalent to predicate device as described herein.

END

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Image /page/5/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble human profiles or flowing lines. The emblem is positioned to the right of the seal.

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

SEP

4 2012

Vatech Co., Ltd. % Mr. Dave Kim, MBA Medical Device Regulatory Affairs Mtech Group 12946 Kimberley Lane HOUSTON TX 77079

Re: K122155

Trade/Device Name: PCH-2500 (PaX-i) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and MQB Dated: August 21, 2012 Received: August 23, 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 ' requirements as be form inrketing your device as described in your Section 510(k) premarket with anow you to begall marketing your antial equivalence of your device to a legally marketed nonfleate 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 11 you desire specific and root of Jour 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 I va may other generers, 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

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):

): K/22/55 K/22/55

Device Name: PCH-2500 (PaX-i)

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

Indications for Use:

PCH-2500 (PaX-i) is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, and x-ray technicians and other professionals licensed by the law of the state in which the device is used.

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
6122155

Concurrence of CDRH, Office of Device Evaluation(ODE)

Page 1 of 1

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.