(282 days)
Not Found
No
The summary describes standard digital X-ray imaging technology and image reconstruction techniques, without mentioning any AI or ML components for image processing, analysis, or diagnosis. The performance studies focus on image quality comparison, not AI/ML model validation.
No
The device is an imaging system used for diagnosis, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "diagnosis of the anatomical structure of the oral and maxillofacial area."
No
The device description explicitly states that the device is composed of hardware components such as an X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), and PC, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The T2 PLUS is an X-ray imaging system. It uses X-rays to create images of the internal structures of the oral and maxillofacial area. It does not analyze biological samples.
- Intended Use: The intended use is for the diagnosis of anatomical structures based on imaging, not on the analysis of biological specimens.
Therefore, the T2 PLUS falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
OAS
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.
Mentions image processing
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.
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray System, Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology
Anatomical Site
oral and maxillofacial area, Maxillofacial
Indicated Patient Age Range
Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.
Intended User / Care Setting
physicians, dentist and X-Ray technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
T2 Plus
Indications for Use (Describe)
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.
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-si |
| Gyeonggi-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
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
5
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
(included
within
range of
predicated
product) |
|-----------------------------|------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 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 |
| | Computed
Tomography | 1515DXT
EXPD1616P | 1515DXT
SEN1 | Similar
(included
within
range of
predicated
product) |
| Image Sensor | Panoramic | 1515DXT
EXPD1616P | 1515DXT
SEN1 | Similar
(included
within
range of
predicated
product) |
| | Cephalometric | XID-C24DC | XID-C24DC | Same |
| Size of Imaging Volume (cm) | | 1515DXT : Max. 15x9
EXPD1616P : Max 15x9
(Stiching Mode : Max 15 X
15) | 1515DXT : Max. 15x9
SEN1 : Max 15x10
(Stiching Mode : Max 15 X
15) | Similar
(included
within
range of
predicated
product) |
| Pixel | Computed
Tomography | 1515DXT :
- 3.94 lp/mm
- 1.97 lp/mm
EXPD1616P : - 5.1 lp/mm
- 2.55 lp/mm | 1515DXT :
- 3.94 lp/mm
- 1.97 lp/mm
SEN1 : - 4.0 lp/mm
- 2.0 lp/mm | Similar
(included
within
range of
predicated
product) |
| Resolution | Panoramic | 1515DXT : 3.94 lp/mm
EXPD1616P : 5.1 lp/mm | 1515DXT : 3.94 lp/mm
SEN1 : 4.0 lp/mm | Similar
(included
within
range of
predicated
product) |
| | Cephalometric | XID-C24DC : 5.0 lp/mm | XID-C24DC : 5.0 lp/mm | Same |
| Pixel Size | Computed
Tomography | 1515DXT : - 127 μm * 127 μm
- 254 μm * 254 μm
EXPD1616P : - 98 μm * 98 μm | 1515DXT :
- 127 μm * 127 μm
- 254 μm * 254 μm
SEN1 : - 125 μm * 125 μm | Similar
(included
within
range of
predicated
product) |
| | | | | 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
8
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
| Standard
| Number | 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 essential |
| performance | |
| EN 60601-1-2: 2015 | Medical electrical equipment - Part 1-2: General requirements for safety and essential |
| performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | |
| IEC 60601-1-3:2008/AMD1 | |
| 2013 | Medical electromagnetic equipment - Part 1-3: General requirements for basic safety and |
| essential performance - Collateral Standard: Radiation protection in diagnostic X-ray | |
| equipment | |
| IEC 60601-2- | |
| 63:2012+A1:2017 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and |
| essential 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: | |
| 2013 | |
| IEC 62366-1: 2015 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential |
| performance - Collateral standard: Usability Medical devices - Application of usability | |
| engineering to medical devices | |
| ISO 15223-1:2021 | Medical Device-Symbols to be used with medical device label, labelling and information to be |
| supplied - 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 and |
| constancy tests - Imaging performance of computed tomography X-ray equipment | |
| ISTA 3A:2018 | Packaged Products for Parcel Delivery System Shipment 70kg(150Ib) of Less |
9
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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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.