This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

Device Description

Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

AI/ML Overview

This document is a 510(k) summary for a medical device called "ROSA Bracket," an orthodontic ceramic bracket. It states that no clinical performance testing was performed on ROSA brackets. Therefore, it is not possible to describe acceptance criteria and a study proving the device meets those criteria, as no such study was conducted according to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Speed Dental Co., Ltd's Orthodontics Bracket, K150141) through non-clinical performance data and biocompatibility testing.

Here's a breakdown of the information that is available, addressing the elements requested where applicable, and explicitly stating where information is not present:

1. A table of acceptance criteria and the reported device performance:

This document does not contain a table of acceptance criteria or reported device performance for a clinical study, as no clinical study was performed. Instead, it provides a "Substantial equivalence comparison" table comparing the ROSA Bracket to its predicate device based on material, design, and dimensions, aiming to demonstrate that the differences are not expected to affect overall performance.

Table 1: Substantial equivalence comparison (from the document)

Manufacturer	GNI Co., LTD (ROSA Bracket)	Speed Dental Co., Ltd (Predicate Device)
510(k) Number	K182672	K150141
Common Name	Orthodontic Ceramic Brackets	Orthodontic Ceramic Brackets
Trade Name	ROSA Bracket	Orthodontics Bracket
Indication for Use	This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only	This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Target Population	Patients in need of teeth alignment correction	Patients in need of teeth alignment correction
Material	Aluminum Oxide	Aluminum Oxide
Biocompatibility	Meets the applicable requirement of ISO 10993	Meets the applicable requirement of ISO 10993
Transparency	Half-transparency	Half-transparency
Design	Hook, Slot, Round home, base and marking	Hook, Slot, Round home, base and marking
Maxillary In-out(mm)	1.0-1.2	1.04-1.19
Maxillary Torque (°)	-7 to +17	-7 to +17
Maxillary Angulation	0-11	0-10
Slot Size	0.022 inch	0.022 inch
Orientation marking	Colored dot on external surface	Colored dot on external surface
Single Use	YES	YES
Non-sterile	YES	YES

The document concludes that the "Rosa Bracket has the same device characteristics as the predicate device... We conclude that Rosa Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K150141)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set was used.
Non-clinical performance data: The document mentions that "design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015, Dentistry -Testing of adhesion to tooth structure." It does not specify the sample size for these non-clinical tests or the data provenance.
Biocompatibility testing: Was completed according to ISO 10993 series. No sample sizes are provided.

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 test set requiring expert ground truth was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set or adjudication was performed.

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. This device is an orthodontic bracket, not an AI or imaging diagnostic tool, and no MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for a clinical study, as none was performed. For the non-clinical tests, the "ground truth" would be established by the standards and methodologies outlined in ISO 27020:2010 and ISO 11405:2015 for physical and mechanical properties.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

In summary, the ROSA Bracket received 510(k) clearance based on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical performance testing (adherence to ISO standards for material, design, and mechanical properties) and biocompatibility testing, rather than through a clinical study with acceptance criteria and direct performance measurement in a patient population.

Summary

{0}------------------------------------------------

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

November 15, 2019

GNI Co., LTD % Sang Myung Regualtory Affair Consultant E&M Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang, 14067 Kr

Re: K182672

Trade/Device Name: ROSA Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: October 7, 2019 Received: October 19, 2018

Dear Sang Myung:

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

{1}------------------------------------------------

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 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 Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K182672

Device Name ROSA Bracket

Indications for Use (Describe)

This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for GNI, which is written in a bold, dark blue font. To the left of the name is a graphic of four squares, two white and two colored. The bottom left square is dark blue, and the bottom right square is red. Underneath the name is the slogan "The Best Quality & Service".

GNI Co., LTD

510(k) Summary

K182672

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

GNI Co., LTD Submitter: 5F, 501: 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong-si, Gyeonggido, 18469, South Korea Telephone: +82-505-600-8880 Fax: -82-505-333-8880 E-mail: admin 02@ggniortho.com

Contact Person: Regulatory Affair/Sang Hwa Myung Telephone: +82-10-4952-6638 E-mail: mshenmc@gmail.com

Date 510(k) summary prepared: October 7, 2018

Trade Name: ROSA Bracket Common Name: Orthodontic Ceramic Brackets Classification Name: Orthodontic plastic bracket Classification: Class II Product Code: NJM Classification Panel: Dental Regulation Numbers: 21 CFR 872.5470 Type of 510(k) submission: Traditional

Description of Device:

Indication for use: This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only

{4}------------------------------------------------

Predicate Device

Primary Manufacturer: Speed Dental Co., Ltd 510(k) Number: K150141 Trade Name: Orthodontics Bracket Common Name: Orthodontic Ceramic Brackets Requlation Name: Orthodontic Plastic Bracket Regulation Numbers: 21 CFR 872.5470 Product Code: NJM Classification: Class II

Substantial Equivalence:

Comparison table is as follows.

Table 1: Substantial equivalence comparison

Manufacturer	GNI Co., LTD	Speed Dental Co., Ltd
510(k)Number	K182672	K150141
Common Name	Orthodontic Ceramic Brackets	Orthodontic Ceramic Brackets
Trade Name	ROSA Bracket	Orthodontics Bracket
Indication for Use	This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only	This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Target Population	Patients in need of teeth alignment correction	Patients in need of teeth alignment correction
Material	Aluminum Oxide	Aluminum Oxide
Biocompatibility	Meets the applicable requirement of ISO 10993	Meets the applicable requirement of ISO 10993
Transparency	Half-transparency	Half-transparency
Design	Hook, Slot, Round home, base and marking	Hook, Slot, Round home, base and marking
Maxillary In-out(mm)	1.0-1.2	1.04-1.19
Maxillary Torque (°)	-7 to +17	-7 to +17
Maxillary Angulation	0-11	0-10
Slot Size	0.022 inch	0.022 inch
orientation marking	Colored dot on external surface	Colored dot on external surface
Single Use	YES	YES
Non-sterile	YES	YES

Information provided in these 510(k) submissions shows that ROSA Brackets are substantially equivalent to the predicate devices in terms of indication for use, device design and performance that related with technological characteristics.

Differences between the proposed and predicate devices are not expected to affect the overall performance of the device. These differences include slight variations in design such as maxillary angulation and In-Out. While the ranges are not identical, they are still within the range of what is typically observed for orthodontic brackets. These differences do not raise different questions of safety or effectiveness.

{5}------------------------------------------------

Biocompatibility testing:

Biocompatibility testing including cytotoxicity, sensitization, oral mucosal irritation was completed according to the following standards: ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices – Part 5 Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

Non-clinical Performance Data:

Non-clinical performance testing was conducted as follows: design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015, Dentistry -Testing of adhesion to tooth structure; A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices.

Clinical Data:

No clinical performance testing was performed on ROSA brackets.

Conclusion

The Rosa Bracket has the same device characteristics as the predicate device, based on the information provided in this summary. We conclude that Rosa Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K150141)

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.