PHT-6500 (PHT-60CFO) 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

PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three different image acquisition modes; panoramic, cephalometirc and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) 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

This device submission is for a medical imaging device (X-ray system), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "training set ground truth," and "sample size for training set" are not applicable. The document also does not provide specific acceptance criteria as quantitative metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device through performance and safety testing.

Here's the information extracted from the provided text, adapted for a medical imaging device:

1. Table of Acceptance Criteria (or Performance Parameters) and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" but rather describes the performance specifications and the testing conducted to show the device's acceptable performance and substantial equivalence to the predicate. The performance listed is primarily functional and technical comparability with the predicate device.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (PHT-6500)
Functional Modes	Panoramic, cephalometric, computed tomography	Panoramic, cephalometric, computed tomography
Input Voltage	AC 100-120/200-240 V	AC 100-120/200-240 V
Tube Voltage	50-90 kV	50-90 kV
Tube Current	2-10 mA	4-10 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	1.9-24 s	0.7-24 s
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	2.8 mmAl	2.8 mmAl
Chin Rest	Equipped Headrest	Equipped Headrest
Mechanical Design	Compact design	Compact design
Electrical Logic Circuit	LDCP logic circuit	LDCP logic circuit
Software Compatibility	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Anatomical Sites	Maxillofacial	Maxillofacial
Imaging Volume (CT)	5x5 cm / 8x5 cm / 8x8 cm (for Xmaru0712CF)	Max. 8x8 cm (for Xmaru0712CF)
	5x5 cm / 8x5 cm / 8.5x8.5 cm / 12x8.5 cm	Max. 12x9 cm (for Xmaru1215CF Plus)
	(for Xmaru1215CF Plus)	Max. 12x9 cm (for Xmaru1215CF Master Plus)
Pixel Resolution (CT)	3.5 lp/mm (for Xmaru0712CF)	3.5 lp/mm (for Xmaru0712CF)
	3.5 lp/mm (for Xmaru1215CF Plus)	3.5 lp/mm (for Xmaru1215CF Plus)
	No equivalent listed	10.1 lp/mm (full res), 5.0 lp/mm (2x2 binning), 2.5 lp/mm (4x4 binning) (Xmaru1215CF Master Plus)
Pixel Resolution (Pano)	5 lp/mm (Xmaru1501CF, Xmaru2301CF)	5 lp/mm (Xmaru1501CF, Xmaru2301CF)
Pixel Resolution (Ceph)	3.9 lp/mm (Xmaru2301CF)	3.9 lp/mm (Xmaru2301CF) (This seems like a typo in the table, likely meant for 910SGA/1210SGA)
Pixel Size (CT)	140x140 μm (Xmaru0712CF, Xmaru1215CF Plus)	140x140 μm (Xmaru0712CF, Xmaru1215CF Plus)
	No equivalent listed	49.5 μm (full res), 99 μm (2x2 binning), 198 μm (4x4 binning) (Xmaru1215CF Master Plus)
Pixel Size (Pano)	100x100 μm (Xmaru1501CF, Xmaru2301CF)	100x100 μm (Xmaru1501CF, Xmaru2301CF)
Pixel Size (Ceph)	No equivalent listed	127x127 μm (910SGA, 1210SGA)

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

The document states: "Based on the non-clinical and clinical consideration and the outcome of a comparative review by a licensed dentist of images from both devices, PHT-6500 (PHT-60CFO) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D (PHT-7000), the predicate device."

Sample Size for Test Set: Not specified. The submission refers to a "comparative review by a licensed dentist of images from both devices," but the number of images or cases reviewed is not mentioned.
Data Provenance: Not explicitly stated. Given that Vatech Co., Ltd. is based in the Republic of Korea, the data likely originated from there. It is not specified if the data was retrospective or prospective.

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

Number of Experts: "a licensed dentist." So, at least one expert.
Qualifications of Experts: "a licensed dentist." Further specific qualifications (e.g., years of experience, specialization) are not provided.

4. Adjudication method for the test set:

Not specified. Since only one "licensed dentist" is mentioned for the comparative review, it implies no formal adjudication process was used among multiple experts. The review was likely a direct comparison by this single expert.

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, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray imaging device, not an AI/ML diagnostic software. The comparison was primarily for image quality and functional equivalence between the new device and a predicate device.

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

Not applicable. This is an X-ray imaging device. The performance relates to the hardware's ability to produce images, not a standalone algorithm.

7. The type of ground truth used:

The term "ground truth" usually refers to definitive factual data in the context of AI/ML performance. For this X-ray device, the "ground truth" relates to the performance characteristics of the images produced and the device's functionality. The clinical consideration and comparative review by a licensed dentist served as a form of "expert assessment" of the device's diagnostic utility and safety/effectiveness in comparison to the predicate. No pathology or outcomes data is explicitly mentioned as "ground truth."

8. The sample size for the training set:

Not applicable. This is a hardware device. There is no mention of a "training set" in the context of AI/ML.

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

Not applicable. As above, there is no "training set."

Summary

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K122606

Special 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: August 23rd, 2012

Submitter's Name, address, telephone number, a contact person:

Submitter's Name : Submitter's Address:

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

Submitter's Telephone: Contact person:

+82-31-379-9585 Mr. Sung-Hee Park

Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	12946 Kimberley Ln, Houston, TX 77079
Telephone:	+713-467-2607
Fax:	+713-464-8880

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/Proprietary Name:	PHT-6500 (PHT-60CFO)
Common Name:	Dental Computed Tomography X-ray System
Classification Name:	System, X-ray, Tomography, Computed , Dental(21CFR 892.1750,Class II)
Product Code:	OAS

Vatech Co., Ltd.

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Predicate Device:

Manufacturer:	Vatech Co., Ltd
Device Name:	PaX-Flex3D (PHT-7000)
510(k) Number:	K121412

Device Description:

Indication for use:

PHT-6500 (PHT-60CFO) 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.

Summary of the technological characteristics of the device compared to the predicate device:

PHT-6500 (PHT-60CFO) described in this special 510(k) submission is substantially equivalent to PaX-Flex3D (K121412) and has the same indications for use and similar technical characteristics as PaX-Flex3D (PHT-7000) of Vatech Co., Ltd. Table 1 summarizes the technological characteristics of the PHT-6500 (PHT-60CFO) vs. the predicate device

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	Table 1. Comparison of PCH-2500 (PaX-i) and PCH-2500 (K113672)ProposedVatech Co., Ltd.	PredicateVatech Co., Ltd.
Characteristic	PHT-6500 (PHT-60CFO)	PaX-Flex3D (PHT-7000)
510(k) number	-	K121412
Indicationsfor use	PHT-6500 (PHT-60CFO)is acomputed tomography x-raysystem intended to producepanoramic, cephalometric orcross-sectional images of the oralanatomy on a real time basis bycomputer reconstruction of x-rayimage data from the same axialplane taken at different angles. Itprovides diagnostic details of theanatomic structures by acquiring360° rotational image sequencesof oral and maxillofacial area for aprecise treatment planning in adultand pediatric dentistry . Thedevice is operated and used byphysicians, dentists, and x-raytechnicians.	PaX-Flex3D (PHT-7000) is acomputed tomography x-ray systemintended to 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.
PerformanceSpecification	Panoramic, cephalometric and computedtomography	Panoramic, cephalometric and computedtomography
Input Voltage	AC 100-120/200-240 V	AC 100-120/200-240 V
Tube Voltage	50-90 kV	50-90 kV
Tube Current	$4\sim10$ mA	$2\sim10$ mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	0.7 - 24 s	1.9 - 24 s
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	2.8 mmAl	2.8 mmAl
Chin Rest	Equipped Headrest	Equipped Headrest
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

Table 1 Comparison of PCH-2500 (PaX-i) and PCH-2500 (K113672)

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Image Receptor		ComputedTomography(Flat Panel Detector)		Xmaru0712CF	Xmaru0712CF
				Xmaru1215CF Plus	Xmaru1215CF Plus
				Xmaru1215CF MasterPlus	-
		Panoramic(CMOS photodiodearray)		Xmaru1501CF	Xmaru1501CF
		CephaloMetric(CMOSphotodiodearray)	Scan Type	Xmaru2301CF	Xmaru2301CF
			One ShotType	1210SGA	-
				910SGA	-
Size of ImagingVolume		Xmaru0712CF		Max. 8 x 8 cm	5 x 5 cm / 8 x 5 cm / 8 x 8 cm
		Xmaru1215CF Plus		Max. 12 x 9 cm	5 x 5 cm / 8 x 5 cm /8.5 x 8.5 cm / 12 x 8.5 cm
		Xmaru1215CFMaster Plus		Max.12 x 9 cm	-
		Xmaru0712CF		3.5 lp/mm	3.5 lp/mm
	CT		Xmaru1215CF Plus	3.5 lp/mm	3.5 lp/mm
PixelResolution			Xmaru1215CFMaster Plus		10.1 lp/mm - full resolution5.0 lp/mm - 2x2 binning2.5 lp/mm - 4x4 binning
	Pano	Xmaru1501CF		5 lp/mm	5 lp/mm
		Xmaru2301CF		5 lp/mm	5 lp/mm
	Ceph	910SGA		3.9 lp/mm	-
		1210SGA		3.9 lp/mm	-
Pixel Size	CT	Xmaru0712CF		140 x 140 $μm$	140 x 140 $μm$
			Xmaru1215CF Plus	140 x 140 $μm$	140 x 140 $μm$
		Xmaru1215CFMaster Plus			49.5 $μm$ - full resolution99 $μm$ - 2x2 binning198 $μm$ - 4x4 binning
	Pano	Xmaru1501CF		100 x 100 $μm$	100 x 100 $μm$
		Xmaru2301CF		100 x 100 $μm$	100 x 100 $μm$
	Ceph	910SGA		127 x 127 $μm$	-
			1210SGA		127 x 127 $μm$

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Summary of Performance Testing:

Indications for use, safety characteristics, and non-clinical performance for panoramic, cephalometric and CBCT sensors of PHT-6500 (PHT-60CFO) and PaX-Flex3D (PHT-7000) are similar. The primary differences are as follows: PHT-6500 (PHT-60CFO) introduces one new cone beam CT sensor, Xmaru1215CF Master Plus, and two new cephalo sensors (One Shot type), 910SGA and 1210SGA. The non-clinical performance and clinical consideration report for the new SSXI sensors are provided separately in this submission. Based on the non-clinical and clinical consideration and the outcome of a comparative review by a licensed dentist of images from both devices, PHT-6500 (PHT-60CFO) is substantially equivalent, in terms of safety and effectiveness, with PaX-Flex3D (PHT-7000), 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.

PHT-6500 (PHT-60CFO) 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 PHT-6500 (PHT-60CFO) 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002

November 20, 2012

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

Re: K122606

Trade/Device Name: PHT-6500 (PHT-60CFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: October 22, 2012 Received: October 25, 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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Diagnostics and Radiological Health 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, J

Janine M. Morris -S

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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510(k) Number (if known): K122606

Device Name: PHT-6500 (PHT-60CFO)

Classification: System, X-ray, Tomography, Computed, Dental (21 CFR 892.1750, Product Code OAS, Class II)

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine M. Morris -5 2012.11.20 15:36:58 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K122606

Page 1 of

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.