PHT-30LFO 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-30LFO, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-30LFO is a complete dental X-ray system equipped with x-fay 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

The provided text is a 510(k) Premarket Notification for the Vatech Co., Ltd. PaX-i3D Smart (PHT-30LFO) dental computed tomography x-ray system. The crucial aspect of this document for your request is demonstrating substantial equivalence to a predicate device (PHT-6500), rather than proving the device meets acceptance criteria through a rigorous clinical study of its diagnostic performance against a ground truth.

The document focuses on comparing the technological characteristics and performance of the new device to a previously cleared predicate device. This is a common approach for 510(k) submissions, where direct clinical superiority or a groundbreaking new diagnostic capability is not typically being claimed or required. Instead, the goal is to show that the new device is as safe and effective as a legally marketed device.

Therefore, the information available does not contain the level of detail you would typically find in a clinical study report that directly proves a device meets specific diagnostic acceptance criteria (e.g., sensitivity, specificity, AUC values against a clinical ground truth). There's no mention of a traditional diagnostic performance study with a test set of patient cases, expert readers, or ROC analysis.

However, I can extract the information that is present, framed in the context of a 510(k) submission for substantial equivalence.

Here's an attempt to answer your questions based on the provided text, acknowledging its limitations for traditional diagnostic performance evaluation:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The "acceptance criteria" in this 510(k) submission are not expressed as specific diagnostic performance metrics (like sensitivity/specificity for a disease). Instead, the acceptance criteria are met by demonstrating that the new device (PHT-30LFO) is substantially equivalent to the predicate device (PHT-6500) in terms of its indications for use, fundamental technological characteristics, safety, and imaging performance.

The study proves the device meets these "acceptance criteria" by showing:

Similar Indications for Use: Both devices are intended to produce panoramic, cephalometric, or cross-sectional images of the oral anatomy for precise treatment planning in adult and pediatric dentistry.
Similar Technological Characteristics: The core components, x-ray parameters, and software functionalities are largely similar or improved without adverse impact.
Non-Clinical Performance Equivalence/Improvement: Bench testing showed the new detectors performed similarly or better than the predicate's detectors in objective image quality metrics.
Safety and Performance Standard Compliance: The device meets relevant international and FDA standards for medical electrical equipment and radiation safety.
Software Verification and Validation: The software meets FDA guidance for medical device software.

Table of Acceptance Criteria (as implied by 510(k) substantial equivalence) and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance/Evidence from Study
1. Indications for Use Equivalence - Produce panoramic, cephalometric or cross-sectional images of oral anatomy. - Provide diagnostic details for precise treatment planning in adult and pediatric dentistry.	Met: "PHT-30LFO 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... 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." (Identical to predicate)
2. Technological Characteristics Equivalence - Similar core system components and functionalities.	Met: The proposed device and predicate device "have the same indications for use and demonstrate the similar technical characteristics." Key components (X-ray tube, generator, detectors, PC system, imaging software) are outlined, showing largely comparable specifications (e.g., focal spot size, slice width, filtration, software names). Differences (new detectors, free input voltage, different CBCT reconstruction algorithm) were addressed and deemed not to negatively impact performance.
3. Non-Clinical Image Quality Performance Equivalence/Non-Inferiority - Image quality metrics (MTF, DQE, NPS) comparable or better.	Met: "Based on Non-Clinical Test results of the new detector Xmaru1404CF... the new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance... The new sensor also exhibits consistently better performances in terms of MTF and NPS." For the other new detector (Xmaru2301CF-O), "test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device." Concluded: "the diagnostic image quality of the new sensor is equal or better than those of the predicate device."
4. Safety and Performance Compliance - Adherence to relevant electrical, mechanical, environmental safety, and radiation control standards.	Met: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 (Ed. 3, 2005), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-2-63 (Ed. 1, 2012) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2." Also meets NEMA PS 3.1-3.18 (DICOM), and EPRC standards (21 CFR 1020.30, 31, 33). "The risks of different voltage requirement of the new device is evaluated and mitigated in electrical safety test."
5. Software Verification & Validation (V&V) - Software is safe and performs as intended.	Met: "Software verification and validation tests were conducted and documented as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern... The predicate device and the proposed device utilize the identical image viewing software." "The functionality and safety of the new iterative reconstruction algorithm for the CT capture mode were assured by the company procedures that conform to accepted practices."
6. Clinical Images Comparative Assessment - Clinical images from the new device are comparable to the predicate.	Met: "clinical images generated from the subject device were compared to a group of images taken from the predicate devices to provide further evidence... to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device." (No specific quantitative metrics or reader study details are provided, implying a qualitative assessment of overall image appearance).

Here are answers to your specific questions, largely reiterating the limitations for a "diagnostic performance study" as typically understood today:

A table of acceptance criteria and the reported device performance:
(See table above) – The "acceptance criteria" are implied by the requirements for substantial equivalence in a 510(k) submission, focusing on safety, effectiveness, and comparable performance to a predicate device, rather than specific diagnostic accuracy metrics.
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for "clinical images." The document mentions "clinical images generated from the subject device were compared to a group of images taken from the predicate devices." No numerical sample size is given for this comparison. For non-clinical tests, it implies the new detectors (Xmaru1404CF, Xmaru2301CF-O) were tested, which would be singular units of the device's components.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter (Vatech Co., Ltd.) is based in the Republic of Korea. It is a retrospective comparison of images rather than a prospective trial with new patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No explicit ground truth establishment process involving multiple experts is described for a diagnostic performance test set. The "clinical images" comparison was made by "qualified individuals employed by the sponsor" for "further evidence" of substantial equivalence. No number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") are mentioned. This is typical for a 510(k) where diagnostic performance isn't being quantitatively proven against a clinical ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described, as there was no formal reader study or establishment of ground truth by multiple readers for diagnostic purposes. The comparison of clinical images appears to be a qualitative assessment by the sponsor's "qualified individuals."
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, a multi-reader multi-case (MRMC) study was not conducted. This document describes a new imaging device comparing its technical performance (image quality, safety) to a predicate, not an AI-powered diagnostic tool requiring a human-in-the-loop performance study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a medical imaging device (CT scanner), not a standalone diagnostic algorithm. The "algorithm" mentioned is "CBCT reconstruction algorithm," which is an integral part of the image production, not a separate diagnostic algorithm. The performance of this algorithm is evaluated as part of the overall image quality metrics (MTF, DQE, NPS) and verified through V&V.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "clinical images" comparison, no formal "ground truth" (like histopathology or long-term outcomes) is mentioned. The comparison was likely based on visual assessment of image quality and anatomical representation being "as intended" and "similar to the predicate device." For non-clinical performance, the "ground truth" is the physical properties of test phantoms used to measure MTF, DQE, and NPS.
The sample size for the training set:
- Not applicable/Not specified. This document is about a hardware device with inherent image reconstruction algorithms, not a machine learning model that requires a distinct "training set" of images in the typical sense.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a machine learning "training set" in the context of this 510(k) submission for a CT imaging system.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2015

Vatech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K152106

Trade/Device Name: PaX-i3D Smart (PHT-30LFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: July 24, 2015 Received: July 29, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152106

Device Name PHT-30LFO PaX-i3D Smart

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 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: July 24, 2015

I. SUBMITTER

Submitter's Name :	Vatech Co., Ltd.
Submitter's Address:	13, Samsung 1-ro 2-gil, Hwaseong-Si, Gyeonggi-Do, 445-170Republic of Korea
Submitter's Telephone:	+82-31-379-9492
Contact person:	Mr. Daniel.Kim
Official Correspondent:(U.S. Designated agent)	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+1- 713-467-2607
Fax:	+1- 713-583-8988

II. DEVICE

Trade/Proprietary Name:	PaX-i3D Smart (PHT-30LFO)
Common Name:	Dental Computed Tomography X-ray System
Regulation Name:	Computed Tomography X-ray System
Classification:	(21CFR 892.1750, Class II)
Product Code:	OAS

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III. PREDICATE DEVICE

Primary Manufacturer:	Vatech Co., Ltd
Device Name:	PHT-6500
Regulation Name :	Computed Tomography X-ray System
Classification No :	21CFR 892.1750, Class II
Product Code:	OAS
510(k) Number:	K122606

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

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.

System's Kev Components:

PHT-30LFO digital x-ray equipment with SSXI detectors (Xmaru1404CF, Xmaru2301CF, . Xmaru2301CF-O, 910SGA, 1210SGA)
. PC system
- CPU: IntelXeon E5-1607 3GHz, 1600 4C or faster
- RAM: 16GB DDR3-1600 ECC RAM / UDIMM A
- Hard disk drive: 1 TB SATA 1st HDD
- Graphic board: ZOTAC NVIDIA Geforce GTX 780 Ti AMP! D5 3GB
Imaging software ●
- EasyDent: 2D viewer and patient management software
- Ez3D Plus : 3D viewer and image analysis software

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INDICATIONS FOR USE: v.

PHT-30LFO 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 xray 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

	Proposed	Predicate
Characteristic	Vatech Co., Ltd.	Vatech Co., Ltd.
	PHT-30LFO (PaX-i3D Smart)	PHT-6500 (PHT-60CFO)
510(k) number	K152106	K122606
Indicationsfor use	PHT-30LFO is a computedtomography x-ray systemintended to produce panoramic,cephalometric or cross-sectional images of the oralanatomy on a real time basis bycomputer reconstruction of x-ray image data from the sameaxial plane taken at differentangles. It provides diagnosticdetails of the anatomicstructures by acquiring 360°rotational image sequences oforal and maxillofacial area for aprecise treatment planning inadult and pediatric dentistry .The device is operated and usedby physicians, dentists, and x-ray technicians.	PHT-6500 (PHT-60CFO) is acomputed tomography x-raysystem intended to producepanoramic, cephalometric orcross-sectional images of theoral anatomy on a real timebasis by computerreconstruction of x-ray imagedata from the same axial planetaken at different angles. Itprovides diagnostic details ofthe anatomic structures byacquiring 360° rotational imagesequences of oral andmaxillofacial area for a precisetreatment planning in adult andpediatric dentistry . The deviceis operated and used byphysicians, dentists, and x-raytechnicians.
Performance Specification	Panoramic,cephalometricandcomputed tomography	Panoramic,cephalometricandcomputed tomography
Input Voltage	AC 100-240 V	AC 100-120/200-240 V
Tube Voltage	50-99 kV	50-90 kV

Tube Current		4 ~16 mA	4 ~10 mA
Focal Spot Size		0.5 mm	0.5 mm
Exposure Time		Max. 18 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		Compact design	Compact design
Electrical		LDCP logic circuit	LDCP logic circuit
Software		DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
2D Image ViewingProgram		EasyDent	EasyDent
3D Image ViewingProgram		Ez3D Plus	Ez3D Plus
Anatomical Sites		Maxillofacial	Maxillofacial
	ComputedTomography	Xmaru1404CF	Xmaru0712CF
			Xmaru1215CF Plus
			Xmaru1215CF Master Plus
Image	Panoramic	Xmaru1404CF	Xmaru1501CF
Receptor	Cephalometric	Xmaru2301CF	Xmaru2301CF
		1210SGA	1210SGA
		910SGA	910SGA
		Xmaru2301CF-O
Size of Imaging Volume(cm)		Xmaru1404CF : Max. 10x8.5	Xmaru0712CF : Max. 8x8
			Xmaru1215CF Plus : Max.12x9
			Xmaru1215CF Master Plus :Max. 12x9
	ComputedTomography	Xmaru1404CF :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning	Xmaru0712CF : 3.5 lp/mm
			Xmaru1215CF Plus : 3.5 lp/mm
PixelResolution			Xmaru1215CF Master Plus :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning
	Panoramic	Xmaru1404CF :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning	Xmaru1501CF :5 lp/mm

	Cephalometric	Xmaru2301CF : 5 lp/mm	Xmaru2301CF : 5 lp/mm
		1210SGA : 3.9 lp/mm	1210SGA : 3.9 lp/mm
		910SGA : 3.9 lp/mm	910SGA : 3.9 lp/mm
		Xmaru2301CF-O : 5 lp/mm
Pixel Size	ComputedTomography	Xmaru1404CF :- 99 $\mu$ m- 2x2 binning- 198 $\mu$ m- 4x4 binning	Xmaru0712CF : 140 × 140 $\mu$ mXmaru1215CF Plus : 140 × 140$\mu$ mXmaru1215CF Master Plus :- 99 $\mu$ m- 2x2 binning- 198 $\mu$ m- 4x4 binning
	Panoramic	Xmaru1404CF :- 99 $\mu$ m- 2x2 binning- 198 $\mu$ m- 4x4 binning	Xmaru1501CF:100 × 100 $\mu$ m
	Cephalometric	Xmaru2301CF : 100 × 100 $\mu$ m	Xmaru2301CF : 100 × 100 $\mu$ m
		1210SGA : 127 × 127 $\mu$ m	1210SGA : 127 × 127 $\mu$ m
910SGA : 127 × 127 $\mu$ m		910SGA : 127 × 127 $\mu$ m
Xmaru2301CF-O : 100 × 100 $\mu$ m

The PHT-30LFO dental CBCT system described in this 510(k) has the similar intended use and technical characteristics as the PHT-6500 of Vatech Co.,Ltd.

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510(k) Submission – PHT-30LFO

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VII. PERFORMANCE DATA

Summary of Performance Testing:

The PHT-30LFO dental CBCT system described in this 510(k) is similar to the predicate device in its indications for use, materials, safety characteristics, X-ray source.

Moreover, the following information further substantial equivalence between two devices:

The fundamental technological characteristics of the subject and predicate device are similar.

Laboratory and clinical performance testing using the same test protocols as used for the cleared detectors was evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.

For both devices, the differences are as follows.

1. Xmaru1404CF, a new SSXI detector for PHT-30LFO, has a different active area compared to Xmary2301CF of PHT-6500 (K122606), the predicate device. Also the subject device offers Xmaru2301CF-O which has different data output interface compared with the Xmaru2301CF of PHT-6500 (K122606).

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510(k) Submission – PHT-30LFO

1. Change to Free Input Voltage: For the predicate device, changing the input voltage from 110V to 230V would require A separate tools and electrical work whereas the new device is equipped with a new power board which is capable of handling the input power between 100 V and 240 V without a separate tool or electrical modification.
1. The CBCT reconstruction algorithm for the subject device is different from the predicate device.

Non-clinical test and clinical consideration test were conducted for the PHT-30LFO system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE) and Noise to Power Spectrum (NPS).

Based on Non-Clinical Test results of the new detector Xmaru1404CF of the subject device, the measured pixel sizes of the new sensor (Xmaru1404CF) are very similar to that of the predicate device (Xmaru1215CF Master Plus). Therefore, compared to the predicate device, the test patterns of the new sensor images show the test subjects without aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new Xmaru1404CF sensor has performed similarly or better than the predicate device in terms of the overall DQE performance, given the DQE variation in low frequency ( ~ 0.5 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF and NPS.

For the new detector Xmaru2301CF-O of PHT-30LFO, the Non-Clinical test results demonstrated the same characteristics in terms of MTF, NPS, and DQE performance compared to Xmaru2301 CF detector of the predicate device. The change in the data output interface has not caused any changes in the performance or the level of artifacts. All performance parameters for both detectors have shown similar results.

In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.

The CBCT image reconstruction for PHT-30LFO applies iterative reconstruction algorithm for the reduction of noise in the CT image capture mode. Iterative reconstruction algorithm reconstructs raw data from the PHT-30LFO dental CBCT system to produce images containing noise levels less than or equal to images produced by standard filtered back projection reconstruction.

In addition to non-clinical tests, clinical images generated from the subject device were compared to

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a group of images taken from the predicate devices to provide further evidence in addition to the laboratory performance data to show that the complete system works as intended and to establish substantial equivalence based on the modifications to the device.

Software Verification and Validation Testing

Software verification and validation tests were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.

The predicate device and the proposed device utilize the identical image viewing software.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(Ed. 3, 2005), IEC 60601-1-3 (Ed. 2, 2008), IEC 60601-2-63 (Ed. 1, 2012) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.

PHT-30LFO 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.

Bench testing according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing - Bench" were performed.

Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were performed.

All test results were satisfactory.

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VIII. CONCLUSIONS

The proposed device and the predicate device have the same indications for use and demonstrate the similar technical characteristics. As demonstrated in the non-clinical considerations, the new detectors performed similar or better than the predicate device in various performance parameters such as DQE, MTF and NPS. The risks of different voltage requirement of the new device is evaluated and mitigated in electrical safety test. The functionality and safety of the new iterative reconstruction algorithm for the CT capture mode were assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.

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-30LFO is safe and effective and substantially equivalent to the predicate device as described herein.

END

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.