T2 Plus by Osstem Implant Co., Ltd.

T2 PLUS is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (PANO), Cephalometric (CEPH), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

Device Description

T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the Xray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

AI/ML Overview

The provided document describes the T2 Plus digital X-ray imaging equipment, focusing on its substantial equivalence to a previously cleared predicate device rather than presenting a detailed study with acceptance criteria for a novel AI or diagnostic algorithm. Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not explicitly stated or applicable in this 510(k) summary.

However, I can extract the information pertinent to the device's performance evaluation and a "study" conducted to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" for diagnostic performance in terms of metrics like sensitivity, specificity, or AUC, as it's a submission for substantial equivalence of imaging equipment, not a new diagnostic algorithm that interprets images. The study's aim was to show equivalent image quality to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Produce images of "same diagnostic quality" as predicate.	"Upon reviewing the evaluator’s scores, it was confirmed that the scores for each question were identical for both the proposed device and the predicate device. This demonstrates that both devices deliver the same level of performance and quality.""In conclusion, the imaging evaluator confirmed that both the proposed device and the predicate device produce radiological images of adequate quality for dental and orthodontic diagnosis."
Produce "radiological images of equivalent quality" for diagnosis.	"This confirmed that the proposed device and the predicate device produce radiological images of equivalent quality, making them suitable for diagnosis."

Acceptance Criterion (Implicit)

Reported Device Performance

Produce images of "same diagnostic quality" as predicate.

"Upon reviewing the evaluator’s scores, it was confirmed that the scores for each question were identical for both the proposed device and the predicate device. This demonstrates that both devices deliver the same level of performance and quality.""In conclusion, the imaging evaluator confirmed that both the proposed device and the predicate device produce radiological images of adequate quality for dental and orthodontic diagnosis."

Produce "radiological images of equivalent quality" for diagnosis.

"This confirmed that the proposed device and the predicate device produce radiological images of equivalent quality, making them suitable for diagnosis."

Note: The acceptance criteria are inferred from the study's objective: to demonstrate equivalent image quality for diagnostic purposes. No specific quantitative thresholds (e.g., "score must be X or higher") are provided.

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

Test Set Sample Size: A total of 31 cases were reviewed.
- CT: 10 cases
- Cephalometric (Ceph): 10 cases
- Panoramic (Pano): 11 cases
- For each case, both the proposed device (T2-CS-P) and the predicate device (T2-CS) images were reviewed, meaning 31 image sets from T2-CS-P and 31 image sets from T2-CS.
Data Provenance: Not explicitly stated regarding country of origin. The study states images were from "patients of the same gender and similar age group, under identical conditions." It implies retrospective image collection from existing patients, as it refers to "patients" not trial participants.
- Given the manufacturer is based in the Republic of Korea, the data may originate from there, but this is not explicitly stated.

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

Number of Experts: "A radiologist" (singular) was used as the "evaluator."
Qualifications of Experts: The qualification provided is "a radiologist." No further details on years of experience, sub-specialty, or board certification are given.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/None explicitly described. Since only one radiologist served as the evaluator, there was no need for adjudication among multiple readers. The radiologist's assessment served as the primary evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

MRMC Study: No. This was not an MRMC study. It involved a single evaluator (radiologist) comparing images from the proposed device and predicate device.
Effect Size: Not applicable, as no MRMC study was performed and no quantitative diagnostic performance metrics (e.g., sensitivity, specificity, AUC) were reported. The evaluation was qualitative ("scores... were identical").

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

Standalone Study: Not applicable. The device is imaging equipment. The "study" evaluated the image quality of the equipment as interpreted by a human radiologist, not the performance of an independent AI algorithm. There is no AI component described that would operate in a "standalone" mode for diagnostic interpretation.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for purpose of this image quality comparison was the expert consensus/opinion of a single radiologist regarding the image quality and its adequacy for diagnosis. This is not a "true" clinical ground truth from pathology or long-term outcomes, but rather a subjective assessment of image utility.

8. The Sample Size for the Training Set:

This information is not provided. The document focuses on performance testing for substantial equivalence, not on the development of an AI model that requires a training set. The device is X-ray imaging equipment, not an AI diagnostic algorithm, so the concept of a "training set" for the device itself is not applicable in the typical sense of machine learning.

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

Not applicable, as there is no description of a "training set" for an AI model within the context of this device's performance evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 6, 2024

Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. FAIRLESS HILLS, PA 19030

Re: K233806

Trade/Device Name: T2 Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: October 17, 2023 Received: November 29, 2023

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233806

Device Name

T2 Plus

Indications for Use (Describe)

Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

er-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, italicized font. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.

B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea 1: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

510(k) Summary

Date: August 05, 2024

1. Company and Correspondent making the submission

- Submitter's Name	: Osstem Implant Co., Ltd.
- Address	: 2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-siGyeonggi-do, 15079, Republic of Korea
- Contact	: Mr. Jinsan Kim
- Phone	: +82-70-4871-8968
- Correspondent's Name	: Hiossen Inc.
- Address	: 85 Ben Fairless Dr. Fairless Hills, PA 19030
- Contact	: Mr. Peter Lee
- Phone	: +1-267-759-7031

2. Proposed Device

-	Trade or (Proprietary) Name	: T2 Plus
-	Model	: T2-C-P, T2-CS-P
-	Classification Name	: Computed tomography x-ray system
-	Regulation Number	: 21CFR892.1750
-	Device Classification	: Class II
-	Classification Product Code	: OAS
-	Clearance	: K233806

3. Predicated Device

Primary Predicate -T2-CS, T2-C, Osstem Implant Co., Ltd. (K212303)

4. Description

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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern, and the orange color is eye-catching.

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea Tel: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software

Proposed Devices Predicated Devices Remark Device Name T2 Plus T2-CS, T2-C Different 510(k) No. K233806 K212303 Different Manufacturer Osstem Implant Co., Ltd. Osstem Implant Co., Ltd. Same T2 PLUS is digital X-Ray T2 is digital X-Ray imaging imaging equipment for equipment for dental dental professionals that professionals that convert Xconvert X-Ray signals into Ray signals into digital digital signals to acquire 2D signals to acquire 2D images images and reconstruct them and reconstruct them into 3D into 3D images, using images, using Panoramic Panoramic (Pano), (Pano), Cephalometric Cephalometric (Ceph), and (Ceph), and Computed Computed Tomography Tomography (CT) (CT) technology for the technology for the diagnosis diagnosis of the anatomical of the anatomical structure of Similar structure of the oral and the oral and maxillofacial (More maxillofacial area. area. added Indications for Use explanation T2-CS-P provides all three of the modes, whereas T2-C-P indication provides the first two modes for use) and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians. Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger. Panoramic, cephalometric Panoramic, cephalometric Perfomance Specification Same and computed tomography and computed tomography 100-240 VAC 100-240 VAC Input Voltage Same Similar (included within Tube Voltage 60-95 KV 60-95 kV

Substantial Equivalence Matrix 5.

range of predicated product)

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Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

Ossterm Implant Co., Ltd..
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Sibeungsi, Gyeongsi-do, 15079, Republic of Korea
Tel: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.c

Tube Current		1-11 mA	5-11mA	Similar(includedwithinrange ofpredicatedproduct)
Focal Spot Size		0.5mm	0.5 mm	Same
Exposure Time		Max. 22s	Max. 22 s	Same
2D Image Viewing Program		Model Name: 2D02	Model Name: 2D02	Same
3D Image Viewing Program		Model Name: 3D02	Model Name: 3D02	Same
Anatomical Sites		Maxillofacial	Maxillofacial	Same
	ComputedTomography	1515DXTEXPD1616P	1515DXTSEN1	Similar(includedwithinrange ofpredicatedproduct)
Image Sensor	Panoramic	1515DXTEXPD1616P	1515DXTSEN1	Similar(includedwithinrange ofpredicatedproduct)
	Cephalometric	XID-C24DC	XID-C24DC	Same
Size of Imaging Volume (cm)		1515DXT : Max. 15x9EXPD1616P : Max 15x9(Stiching Mode : Max 15 X15)	1515DXT : Max. 15x9SEN1 : Max 15x10(Stiching Mode : Max 15 X15)	Similar(includedwithinrange ofpredicatedproduct)
Pixel	ComputedTomography	1515DXT :- 3.94 lp/mm- 1.97 lp/mmEXPD1616P :- 5.1 lp/mm- 2.55 lp/mm	1515DXT :- 3.94 lp/mm- 1.97 lp/mmSEN1 :- 4.0 lp/mm- 2.0 lp/mm	Similar(includedwithinrange ofpredicatedproduct)
Resolution	Panoramic	1515DXT : 3.94 lp/mmEXPD1616P : 5.1 lp/mm	1515DXT : 3.94 lp/mmSEN1 : 4.0 lp/mm	Similar(includedwithinrange ofpredicatedproduct)
	Cephalometric	XID-C24DC : 5.0 lp/mm	XID-C24DC : 5.0 lp/mm	Same
Pixel Size	ComputedTomography	1515DXT :- 127 μm * 127 μm- 254 μm * 254 μmEXPD1616P :- 98 μm * 98 μm	1515DXT :- 127 μm * 127 μm- 254 μm * 254 μmSEN1 :- 125 μm * 125 μm	Similar(includedwithinrange ofpredicatedproduct)
				Similar
		1515DXT :	1515DXT :	(included
		- 127 μm * 127 μm	- 127 μm * 127 μm	within
	Panoramic	EXPD1616P :	SEN1 :	range of
		- 98 μm * 98 μm	- 125 μm * 125 μm	predicated
				product)
		XID-C24DC	XID-C24DC
	Cephalometric	- 100 μm * 100 μm	- 100 μm * 100 μm	Same
		[CT]
		- 1515DXT : 146 x 146 mm	[CT]
		- EXPD1616P :	- 1515DXT : 146 x 146 mm	Similar
		159.5 x 147 mm	- SEN1 : 160 x 128 mm	(included
		[Pano]	[Pano]	within
Active Area		- 1515DXT : 146 x 8.13 mm	- 1515DXT : 146 x 8.13 mm	range of
		- EXPD1616P :	- SEN1 : 160 x 8 mm	predicated
		159.5 x 7.8 mm	[Ceph]	product)
		[Ceph]	- 1.8 x 150 mm
		- 240 x 4.8 mm
		Condition: 0.5 lp/mm	Condition: 0.5 lp/mm	Similar
		[1616P]	[Sen1]	(included
DQE		76%	71%	within
		[1515DXT]	[1515DXT]	range of
		64%	64%	predicated
				product)
		Condition: 1 lp/mm	Condition: 1 lp/mm	Similar
		[1616P]	[Sen1]	(included
MTF		64%	64%	within
		[1515DXT]	[1515DXT]	range of
		56%	56%	predicated
				product)
		The proposed devices and the predicated devices are made with same
		indications for use, performance, materials, and safety characteristics.

		Compared to the predicated devices, the proposed devices have different
		tube voltage, tube current, size of image volume, Pixel Resolution, Pixel
			Size and Active Area. Most of the differences are all within the scope of
S.E.			the predicated device except for pixel size of computed tomography. The
			pixel size of computed tomography concerning sensor has the same with
			predicated deivce and larger pixel output (15 x 15) is possible by the built-
		in stiching mode of software.
			Therefore, we stated that proposed device(T2-CS-P, T2-C-P) are
			substantially equivalent to the predicated devices (T2-CS, T2-C) cleared in
		K212303.

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Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea
Tel: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

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Image /page/8/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font with a registered trademark symbol. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and clean, with a focus on the company name.

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea
Tel: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

6. Apllied Standards

StandardNumber	Standard Name
ISO 13485:2016	Medical devices - Quality management systems - Requirements for regulatory purposes
IEC 60601-1:2005/AMD1:2012	Medical electrical equipment - Part 1: General requirements for basic safety and essentialperformance
EN 60601-1-2: 2015	Medical electrical equipment - Part 1-2: General requirements for safety and essentialperformance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-3:2008/AMD12013	Medical electromagnetic equipment - Part 1-3: General requirements for basic safety andessential performance - Collateral Standard: Radiation protection in diagnostic X-rayequipment
IEC 60601-2-63:2012+A1:2017	Medical electrical equipment - Part 2-63: Particular requirements for the basic safety andessential performance of dental extra-oral X-ray equipment
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
IEC 62304: 2006/AMD1 2015	Medical device software - Software life cycle processes
IEC 60601-1-6: 2010+AMD1:2013IEC 62366-1: 2015	Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability Medical devices - Application of usabilityengineering to medical devices
ISO 15223-1:2021	Medical Device-Symbols to be used with medical device label, labelling and information to besupplied - Part 1: General requirements
ISO 20417:2021	Medical devices - Information to be supplied by the manufacturer
EN ISO 14971:2019	Medical devices - Application of risk management to medical devices
ISO TR 24971:2020	Medical devices - Guidance on the application of ISO 14971
IEC 61223-3-4:2000	Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests -Imaging performance of dental X-ray equipment
IEC 61223-3-5:2019	Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance andconstancy tests - Imaging performance of computed tomography X-ray equipment
ISTA 3A:2018	Packaged Products for Parcel Delivery System Shipment 70kg(150Ib) of Less

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Image /page/9/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a stylized font, with the word "IMPLANT" written in a smaller, simpler font underneath. The logo is simple and clean, with a focus on the company name.

-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea 1: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

7. Applied guideline

Electronic Submission Template for Medical Device 510(k) Submissions issued on October2,2023
The Special 510(k) Program issued on September 13.2019
Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff JUNE 2022
Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff NOVEMBER 2017
Premarket Assessment of Pediatric Medical Devices Guidance for Industry and FDA Staff MARCH 2014
Content of Premarket Submissions for Device Software Functions issued on June 2023
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices issued on September 2016
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions issued on September 2023

8. Indications for Use

T2 PLUS is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.

T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

9. Summary of Non-Clinical Performance Testing

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

Non-Clinical Performance Data

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

A study was conducted to assess whether the clinical images from the T2 and T2 Plus devices provide the same diagnostic quality when reviewed by a radiologist.

To demonstrate that the two devices produce images of the same quality, images from

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Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. The logo is simple and modern.

2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea Tel: +82 70 4626 0782 Fax: +82 70 4015 0508 www.osstem.com

patients of the same gender and similar age group, under identical conditions, were compared. Additionally, both the proposed and predicate devices feature three modes-CT, Pano, and Ceph-each of which was evaluated (CT: 10 cases, Ceph: 10 cases, Pano: 11 cases). A total of 31 cases were reviewed (T2-CS-P: 31 images, T2-CS: 31 images). Questions regarding image quality were conducted to the evaluator to determine their Image is enough to determine diagnose.

Upon reviewing the evaluator' scores, it was confirmed that the scores for each question were identical for both the proposed device and the predicate device. This demonstrates that both devices deliver the same level of performance and quality.

In conclusion, the imaging evaluator confirmed that both the proposed device and the predicate device produce radiological images of adequate quality for dental and orthodontic diagnosis.

This confirmed that the proposed device and the predicate device produce radiological images of equivalent quality, making them suitable for diagnosis.

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

T2 Plus complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.

10. Summary of Clinical Testing

No clinical studies are submitted.

11. Conclusion

The indication for use and the technical characteristics of the subject device 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 size of image volume however, the non-clinical 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.