T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crossectional 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

"T1-C, T1-CS", 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, "T1-C, T1-CS" are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. 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 X-ray detector. T1-CS provides three modes, Whereas, T1-C provides only panoramic and cone beam computed tomography mode.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the T1-C and T1-CS computed tomography x-ray systems. The document states that the devices are substantially equivalent to a predicate device (PHT-30LFO, K152106), but it does not provide specific acceptance criteria or details of a study proving the device meets those criteria.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (numerical thresholds for performance metrics) are explicitly stated in the document. The document generally asserts substantial equivalence based on technical characteristics and clinical image quality.

The performance specifications of the subject device (T1-CS, T1-C) and the predicate device (PHT-30LFO) are listed as follows:

Characteristic	Subject Device (T1-CS, T1-C)	Predicate Device (PHT-30LFO)
`510(k) number`	K183475	K152106
`Indications for Use`	Similar	Similar
`Performance Specification`	Panoramic, cephalometric and computed tomography	Panoramic, cephalometric and computed tomography
`Input Voltage`	AC 100-240 V	AC 100-240 V
`Tube Voltage`	60-100 kV	50-99 kV
`Tube Current`	5~16 mA	4~16 mA
`Focal Spot Size`	0.5 mm	0.5 mm
`Exposure Time`	Max. 22 s	Max. 18 s
`Slice Width`	0.2-1.0mm	0.1 mm min
`Chin Rest`	Equipped Headrest	Equipped Headrest
`Mechanical`	Compact design	Compact design
`2D Image Viewing Program`	Model Name: 2D01, 2D02	EasyDent
`3D Image Viewing Program`	Model Name: 3D01, 3D02	Ez3D Plus
`Anatomical Sites`	Maxillofacial	Maxillofacial

Image Receptor/Resolution/Pixel Size Comparison:

Image Receptor/Metric	Subject Device (T1-CS, T1-C)	Predicate Device (PHT-30LFO)
Computed Tomography
Image Receptor	1515DXT, SEN1	Xmaru1404CF
Size of Imaging Volume (cm)	1515DXT: Max. 15x9; SEN1: Max 15x10	Xmaru1404CF: Max. 10x8.5
Pixel Resolution	1515DXT: 3.94 lp/mm (1x1), 1.97 lp/mm (2x2); SEN1: 4.0 lp/mm (1x1), 2.0 lp/mm (2x2)	Xmaru1404CF: 5.0 lp/mm (2x2), 2.5 lp/mm (4x4)
Pixel Size	1515DXT: 127 µm (1x1), 254 µm (2x2); SEN1: 125 µm (1x1), 250 µm (2x2)	Xmaru1404CF: 99 µm (2x2), 198 µm (4x4)
Active Area	1515DXT: 146 x 146 mm; SEN1: 160 x 128 mm (CT)	Xmaru1404CF: 135.8 x 36.4 mm (CT)

Panoramic
Image Receptor	1515DXT, SEN1	Xmaru1404CF
Pixel Resolution	1515DXT: 3.94 lp/mm; SEN1: 4.0 lp/mm	Xmaru1404CF: 5.0 lp/mm (2x2), 2.5 lp/mm (4x4)
Pixel Size	1515DXT: 127 µm; SEN1: 125 µm	Xmaru1404CF: 99 µm (2x2), 198 µm (4x4)
Active Area	1515DXT: 146 x 8.13 mm; SEN1: 160 x 8 mm (Pano)	Xmaru1404CF: 135.8 x 5.94 mm (Pano)

Cephalometric
Image Receptor	XID-C24DC	Xmaru2301CF, 1210SGA, 910SGA, Xmaru2301CF-O
Pixel Resolution	XID-C24DC: 5 lp/mm	Xmaru2301CF: 5 lp/mm; 1210SGA/910SGA: 3.9 lp/mm; Xmaru2301CF-O: 5 lp/mm
Pixel Size	XID-C24DC: 100 µm	Xmaru2301CF: 100x100 µm; 1210SGA/910SGA: 127x127 µm; Xmaru2301CF-O: 100x100
Active Area	(Ceph)	Xmaru2301CF: 5.9 x 230.4 mm; 1210SGA: 260.1 x 325.1 mm (Ceph)

The document notes: "Although the detector sizes of our device and the predicate device are different, this difference does not affect the substantially equivalent performance of our device to the predicate, and it does not affect the scope of intended use compared to the predicate device."

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

Sample Size: A "clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area." However, no specific sample size (number of patients or images) for this clinical study is provided.
Data Provenance: The document states, "The clinical images of patients are presented as the clinical data..." The country of origin of the data is not explicitly mentioned, nor is it specified whether the study was retrospective or prospective.

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

Number of Experts: "The images acquired using T1-C. T1-CS were reviewed by qualified clinicians..." The specific number of qualified clinicians is not provided.
Qualifications of Experts: The experts are described as "qualified clinicians" and "licensed professional(s)". No further details regarding their specific specialty (e.g., radiologists, dentists), years of experience, or board certifications are mentioned.

4. Adjudication Method for the Test Set

The document states that images were "reviewed by qualified clinicians to be of acceptable clinical effectiveness." No specific adjudication method (e.g., 2+1, 3+1, none) is provided. It simply indicates a review process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results. The study described focuses on the image quality of the subject device itself, not a comparison of human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

The T1-C and T1-CS are computed tomography x-ray systems that produce images. They are not explicitly described as AI algorithms where standalone (algorithm-only) performance would be a primary metric for an AI device. The "imaging software" components (2D Viewer: Xvision, One vision; 3D Viewer: OneClinic, One 3D) are for viewing and reconstruction, not explicitly AI for diagnostic interpretation. Therefore, this question is not applicable in the context of an AI device's standalone performance as the primary focus seems to be on the imaging system itself.

7. Type of Ground Truth Used

The "clinical study" evaluated "image quality" and clinicians confirmed "acceptable clinical effectiveness." This suggests a qualitative assessment of clinical image quality based on expert opinion/review, rather than a quantitative ground truth established by pathology, specific outcomes data, or a strict expert consensus on specific abnormalities.

8. Sample Size for the Training Set

The document mentions "Software was designed and developed according to a software development process." However, no specific sample size for a training set is provided. Given that the "imaging software" listed are viewers/reconstructors rather than AI diagnostic tools, the concept of a "training set" in the context of machine learning may not strictly apply here.

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

As no training set is mentioned in the context of an AI algorithm, this information is not provided/applicable.

Summary

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August 30, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osstem Implant Co., Ltd. % Peter Lee Official Correspondent Hiossen Inc. 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K183475

Trade/Device Name: T1-C. T1-CS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: December 13, 2018 Received: December 17, 2018

Dear Peter Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K183475

Device Name T1-C, T1-CS

Indications for Use (Describe)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. There is a small orange swirl design to the right of the word "OSSTEM".

510(k) Summary

(K183475)

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

1. Date : 7/31/2019

2. Submitter / Correspondent

Submitter:	OSSTEM IMPLANT Co., Ltd.
	2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si,
	Gyeonggi-do, 15079, Republic of Korea
	Contact: Jiyoon Ha
	Tel.: +82 70 4394 7809

Correspondent's Name:	HIOSSEN Inc.
	85 Ben Fairless Drive, Fairless Hills, PA 19030
	Contact: Peter Lee
	Tel.: 267-759-7031

3. Trade/Proprietary Name:

T1-C. T1-CS

4. Common Name:

Computed tomography x-rav system

5. Classification:

21 CFR 892.1750, Class II Classification Name: Computed tomography X-ray system Product Code, OAS

6. Device Description:

SYSTEM's Key Components:

· SSXI detectors (1515DXT, SEN1, XID-C24DC)
· PC system
- CPU: Intel i5-4590 3.0GHz
- RAM: > 8GB
- Hard disk drive: 256GB (SSD recommended)
- Graphic board: Nvidia GeForce GTX970
- Hard disk space: 256GB
· Imaging Software
- 2D Viewer : Xvision (Model Name : 2D-001), One vision (Model Name : 2D-002)
- 3D Viewer : OneClinic (Model Name : 3D-001), One 3D (Model Name : 3D-002)

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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the letters connected in a stylized font. Below "OSSTEM", the word "IMPLANT" is written in gray, in a smaller, sans-serif font. The logo is simple and modern, with a focus on the brand name.

7. Indication for use:

8. Predicate Device:

Manufacturer: Vatech Co., Ltd Device Name: PHT-30LFO (Pax-i3D Smart) Regulation Name: Computed Tomography X-ray System Classification No.: 21CFR 892.1750, Class II Product Code: OAS 510(k) Number: K152106

9. Substantial Equivalence:

"T1-CS, T1-C" described in this 510(k) has the similar intended use and technical characteristics as the PHT-30LFO of Vatech Co., Ltd.

Although the detector sizes of our device and the predicate device are different, this difference does not affect the substantially equivalent performance of our device to the predicate, and it does not affect the scope of intended use compared to the predicate device.

Characteristic	Subject DeviceOSSTEM IMPLANT Co., Ltd.T1-CS, T1-C	Predicate DeviceVatech Co., Ltd.PHT-30LFO (PaX-i3D Smart)
510(k) number	K183475	K152106
Indications for Use	T1-C, T1-CS are a computedtomography x-ray system intendedto produce panoramic,cephalometric or crosssectionalimages of the oral anatomy on areal time 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.T1-CS provides three modes,whereas, T1-C provides onlypanoramic and cone beamcomputed tomography mode.	PHT-30LFO is a computedtomography x-ray system intendedto produce panoramic,cephalometric or crosssectionalimages of the oral anatomy on areal time 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.
Performance Specification	Panoramic, cephalometricand	Panoramic,cephalometricand
	computed tomography	computed tomography
Input Voltage	AC 100-240 V	AC 100-240 V
Tube Voltage	60-100 kV	50-99 kV
Tube Current	5~16 mA	4~16 mA
Focal Spot Size	0.5 mm	0.5 mm
Exposure Time	Max. 22 s	Max. 18 s
Slice Width	0.2-1.0mm	0.1 mm min

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2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea

Image /page/5/Picture/2 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern, and it is likely used to promote the company's dental implant products.

	Chin Rest	Equipped Headrest	Equipped Headrest
	Mechanical	Compact design	Compact design
	2D Image Viewing Program	Model Name: 2D01, 2D02	EasyDent
	3D Image Viewing Program	Model Name: 3D01, 3D02	Ez3D Plus
	Anatomical Sites	Maxillofacial	Maxillofacial
ImageReceptor	ComputedTomography	1515DXTSEN1	Xmaru1404CF
	Panoramic	1515DXTSEN1	Xmaru1404CF
	Cephalometric	XID-C24DC	Xmaru2301CF1210SGA910SGAXmaru2301CF-O
Size of Imaging Volume(cm)		1515DXT : Max. 15x9SEN1 : Max 15x10	Xmaru1404CF : Max. 10x8.5
PixelResolution	ComputedTomography	1515DXT :- 3.94 lp/mm -1x1 binning- 1.97 lp/mm - 2x2 binningSEN1 :- 4.0 lp/mm - 1x1 binning- 2.0 lp/mm - 2x2 binning	Xmaru1404CF :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning
	Panoramic	1515DXT : 3.94 lp/mmSEN1 : 4.0 lp/mm	Xmaru1404CF :- 5.0 lp/mm - 2x2 binning- 2.5 lp/mm - 4x4 binning
	Cephalometric	XID-C24DC : 5 lp/mm	Xmaru2301CF : 5 lp/mm1210SGA : 3.9 lp/mm910SGA : 3.9 lp/mmXmaru2301CF-O : 5 lp/mm
Pixel Size	ComputedTomography	1515DXT :- 127 $μm$ - 1x1 binning- 254 $μm$ - 2x2 binningSEN1 :- 125 $μm$ - 1x1 binning- 250 $μm$ - 2x2 binning	Xmaru1404CF :- 99 $μm$ - 2x2 binning- 198 $μm$ - 4x4 binning
	Panoramic	1515DXT: 127 $μm$SEN1: 125 $μm$	Xmaru1404CF :- 99 $μm$ - 2x2 binning- 198 $μm$ - 4x4 binning
	Cephalometric	XID-C24DC: 100 $μm$	Xmaru2301CF : 100 x 100 $μm$1210SGA : 127 x 127 $μm$910SGA : 127 x 127 $μm$Xmaru2301CF-O : 100 x 100
Active Area		[CT]· 1515DXT : 146 x 146 mm· SEN1 : 160 x 128 mm[Pano]· 1515DXT : 146 x 8.13 mm· SEN1 : 160 x 8 mm[Ceph]	[CT]· Xmaru1404CF : 135.8 x 36.4 mm[Pano]· Xmaru1404CF : 135.8 x 5.94 mm[Ceph]· Xmaru2301CF : 5.9 x 230.4 mm· 1210SGA : 260.1 x 325.1 mm

10. Performance Data:

Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

Non-Clinical Performance Data

We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors.

Clinical Performance Data

A clinical study was completed to evaluate the image quality of T1-C, T1-CS's maxillofacial area. The clinical images of patients are presented as the clinical data including date and signature by a licensed professional. The images acquired using T1-C. T1-CS were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use. The results show that the imaging position, which is different from the one in the predicate device, gives a clinically sufficient image quality.

Software Verification and Validation Testing

Software was designed and developed according to a software development process. Also, Software verification and validation test were conducted and documented in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005. The software for this device contains "Moderate" level of concern software.

Safety, EMC and Performance Data

T1-C, T1-CS complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.

A IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 Medical electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X ray equipment
IEC 60601-2-63:2012 (First Edition) Medical electrical equipment - Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC62366:2007 (First Edition) + A1: 2014 Medical devices – Application of usability engineering to medical devices
A Non-Clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Device"
Testing to confirm compliance with Acceptance Tests

11. Conclusion:

The indication for use and the technical characteristics of the is substantially equivalent to the predicate device. It is substantially equivalent to predicate device in output characteristics and operation mode (CT, Cephalo, Panorama). The major difference is active area size, however, the nonclinical and clinical study results show that the subject device is substantially equivalent to the predicate device. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and Based on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.

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.