(60 days)
T2 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 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 X-ray 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.
The provided document is a 510(k) summary for the T2 imaging device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.
Therefore, many of the requested details regarding acceptance criteria for clinical performance, sample sizes, expert qualifications, and ground truth establishment from a clinical trial perspective are not available in this document. The document explicitly states: "No clinical studies are submitted."
Here's a breakdown of the available information based on the prompt's questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity) against a clinical ground truth. Instead, the substantial equivalence hinges on non-clinical performance tests demonstrating compliance with relevant standards and technical specifications being similar to the predicate device.
The closest to "acceptance criteria" are the performance specifications listed in the "Substantial Equivalence Matrix" (pages 4-5) which compare the proposed device (T2) to the predicate device (T1-CS, T1-C). These are primarily technical specifications rather than diagnostic performance metrics.
| Feature | Acceptance Criteria (Predicate's Performance) | Reported Device Performance (T2) | Outcome |
|---|---|---|---|
| Device Name | T1-CS, T1-C | T2 | Different |
| 510(k) No. | K183475 | Proposed | Different |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same |
| Indications for Use | Similar description for imaging oral anatomy | Similar description for imaging oral anatomy | Same |
| Performance Specification | Panoramic, cephalometric and computed tomography | Panoramic, cephalometric and computed tomography | Same |
| Input Voltage | 100-240 VAC | 100-240VAC | Same |
| Tube Voltage | 60-100 kV | 60-95KV | Similar (included within range of predicated product) |
| Tube Current | 5-16 mA | 5-11mA | Similar (included within range of predicated product) |
| Focal Spot Size | 0.5 mm | 0.5mm | Same |
| Exposure Time | Max. 22 s | Max. 22s | Same |
| 2D Image Viewing Program | Model Name: 2D01, 2D02 | Model Name: 2D02 | Similar (included within predicated product) |
| 3D Image Viewing Program | Model Name: 3D01, 3D02 | Model Name: 3D02 | Similar (included within predicated product) |
| Anatomical Sites | Maxillofacial | Maxillofacial | Same |
| Image Sensor (Computed Tomography) | 1515DXT, SEN1 | 1515DXT, SEN1 | Same |
| Image Sensor (Panoramic) | 1515DXT, SEN1 | 1515DXT, SEN1 | Same |
| Image Sensor (Cephalometric) | XID-C24DC | XID-C24DC | Same |
| Size of Imaging Volume (CT) | 1515DXT: Max. 15x9, SEN1: Max 15x10 (Stitching Mode: Max 15 X 15) | 1515DXT: Max. 15x9, SEN1: Max 15x10 | Similar (included within range of predicated product) |
| Pixel Resolution (CT) | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm (-) | Same (The listed values for T2 are the high-resolution modes of predicate) |
| Pixel Resolution (Panoramic) | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | 1515DXT: 3.94 lp/mm, SEN1: 4.0 lp/mm | Same |
| Pixel Resolution (Cephalometric) | XID-C24DC: 5 lp/mm | XID-C24DC: 5 lp/mm | Same |
| Pixel Size (CT) | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | Similar (included within range of predicated product) |
| Pixel Size (Panoramic) | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | 1515DXT: 127 μm * 127 μm, SEN1: 125 μm * 125 μm | Same |
| Pixel Size (Cephalometric) | XID-C24DC: 100 μm * 100 μm | XID-C24DC: 100 μm * 100 μm | Same |
| Active Area (CT) | 1515DXT: 146 x 146 mm, SEN1: 160 x 128 mm | 1515DXT: 146 x 146 mm, SEN1: 160 x 128 mm | Same |
| Active Area (Pano) | 1515DXT: 146 x 8.13 mm, SEN1: 160 x 8 mm | 1515DXT: 146 x 8.13 mm, SEN1: 160 x 8 mm | Same |
| Active Area (Ceph) | 1.8 x 150 mm | 1.8 x 150 mm | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical studies were submitted. Non-clinical performance tests were conducted, but details on the "test set" for those are not provided in terms of origin or type (e.g., phantom data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies were submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were submitted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The T2 device is an X-ray imaging system, not an AI-assisted diagnostic tool. No clinical studies, let alone MRMC studies, were reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The T2 device is an X-ray imaging system, not an AI algorithm. Its performance is related to image acquisition and reconstruction, not autonomous diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were submitted. For the non-clinical performance, the "ground truth" would be established by physical measurements and adherence to technical standards.
8. The sample size for the training set
Not applicable. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. This device is a hardware imaging system, not a machine learning algorithm.
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September 21, 2021
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. FAIRLESS HILLS PA 19030
Re: K212303
Trade/Device Name: T2 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS, Dated: July 20, 2021 Received: July 23, 2021
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
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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 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 (OS) 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 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-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,
Laurel M. Digitally signed by
Laurel M. Burk -S
Burk -S
Date: 2021.09.21
09:01:35 -04'00'
, 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) K212303
Device Name T2
Indications for Use (Describe)
T2 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.
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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m Implant Co., Ltd ong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea 82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
K212303 - 510(k) Summary
Date: July 20, 2021
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. Jinwoo Bae |
| - Phone | : +82-70-4626-0701 |
| - 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 |
|---|---|
| Classification Name | : X-Ray, Tomography, Computed, Dental |
| Regulation Number | : 21CFR892.1750 |
| Device Classification | : Class II |
| Classification Product Code | : OAS |
3. Predicated Device
Primary Predicate -T1-CS, T1-C, Osstem Implant Co., Ltd. (K183475)
4. Description
- T2 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 X-ray 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
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Image /page/4/Picture/0 description: The image contains 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, lighter font. There is a small circle above the right side of the word "OSSTEM".
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
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 | T1-CS, T1-C | Different | |
| 510(k) No. | Proposed | K183475 | Different | |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Same | |
| Indications for Use | T2 is digital X-Ray imagingequipment for dentalprofessionals that convert X-Ray signals into digitalsignals to acquire 2D imagesand reconstruct them into 3Dimages, using Panoramic(Pano), Cephalometric(Ceph), and ComputedTomography (CT)technology for the diagnosisof the anatomical structure ofthe oral and maxillofacialarea. | T1-C, T1-CS are are acomputed tomography x-raysystem intended to producepanoramic, cephalometric orcrossectional images of theoral anatomy on a real timebasis by computerreconstruction of X-rayimage data from the sameaxial plane taken at differentangleds. It providesdiagnostic details of theanatomic structures byacquiring 360° rotationalimage sequences of oral andmaxillofacial area from aprecise treatment planninginadult and pediatric dentistry.The device is operated andused by physicians, dentists,and X-ray technicians. | Same | |
| Perfomance Specification | Panoramic, cephalometricand computed tomography | Panoramic, cephalometricand computed tomography | Same | |
| Input Voltage | 100-240VAC | 100-240 VAC | Same | |
| Tube Voltage | 60-95KV | 60-100 kV | Similar(includedwithinrange ofpredicatedproduct) | |
| Tube Current | 5-11mA | 5-16 mA | 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: 2D01, 2D02 | Similar | |
| (includedwithinpredicatedproduct) | ||||
| 3D Image Viewing Program | Model Name: 3D02 | Model Name: 3D01, 3D02 | Similar(includedwithinpredicatedproduct) | |
| Anatomical Sites | Maxillofacial | Maxillofacial | Same | |
| ImageSensor | ComputedTomography | 1515DXTSEN1 | 1515DXTSEN1 | Same |
| Panoramic | 1515DXTSEN1 | 1515DXTSEN1 | Same | |
| Cephalometric | XID-C24DC | XID-C24DC | Same | |
| 1515DXT : Max. 15x9SEN1 : Max 15x10(Stiching Mode : Max 15 X 15) | 1515DXT : Max. 15x9SEN1 : Max 15x10 | Similar(includedwithinrange ofpredicatedproduct) | ||
| Size of Imaging Volume(cm) | ||||
| PixelResolution | ComputedTomography | 1515DXT :- 3.94 lp/mmSEN1 :- 4.0 lp/mm | 1515DXT :- 3.94 lp/mm- 1.97 lp/mmSEN1 :- 4.0 lp/mm- 2.0 lp/mm | Same |
| Panoramic | 1515DXT : 3.94 lp/mmSEN1 : 4.0 lp/mm | 1515DXT : 3.94 lp/mmSEN1 : 4.0 lp/mm | Same | |
| Cephalometric | XID-C24DC : 5 lp/mm | XID-C24DC : 5 lp/mm | Same | |
| Pixel Size | ComputedTomography | 1515DXT :- 127 μm * 127 μmSEN1 :- 125 μm * 125 μm | 1515DXT :- 127 μm * 127 μm- 254 μm * 254 μmSEN1 :- 125 μm * 125 μm- 250 μm * 250 μm | Similar(includedwithinrange ofpredicatedproduct) |
| Panoramic | 1515DXT :- 127 μm * 127 μmSEN1 :- 125 μm * 125 μm | 1515DXT :- 127 μm * 127 μmSEN1 :- 125 μm * 125 μm | Same | |
| Cephalometric | XID-C24DC- 100 μm * 100 μm | XID-C24DC- 100 μm * 100 μm | Same | |
| 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 | [CT]- 1515DXT : 146 x 146 mm- SEN1 : 160 x 128 mm[Pano]- 1515DXT : 146 x 8.13 mm- SEN1 : 160 x 8 mm | Same |
5. Substantial Equivalence Matrix
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Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font above the word "IMPLANT" in a smaller, lighter font. The logo is simple and modern.
Osstem Implant Co., Ltd.
OSSTERM IMPLANT CO., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Gibentg-si, Gyeonegi-do, 15079, Republic of Korea
Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem
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Image /page/6/Picture/0 description: The image contains 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, lighter font. The logo is simple and modern.
n Implant Co., Ltd
on-gil. Siheung-si. Gyeonggi-do. 15079. Republic of Korea Fax: +82 70 4394 0404 www.osstem.com
| [Ceph]- 1.8 x 150 mm | [Ceph]- 1.8 x 150 mm | |
|---|---|---|
| -------------------------- | -------------------------- | -- |
6. Indications for Use
- T2 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.
7. 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.
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 complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC60601-1, IEC60601-1-2.
8. Summary of Clnical Testing
No clinical studies are submitted.
9. 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
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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, and it is likely used to represent the company's brand.
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do, 15079, Republic of Korea
Tel: +82 70 4626 0701 Fax: +82 70 4394 0404 www.osstem.com
on the information provided in this submission, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.
§ 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.