ORTHODONTIC CERAMIC BRACKET by STAR DENTECH KOREA., CORP

Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring. And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Orthodontic Ceramic Bracket (ABSOLUTE)". However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the information available:

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

The document states: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

This is a very general statement and does not provide specific acceptance criteria or detailed device performance metrics. It indicates that some testing was done to a standard, but the specifics are not included in this summary. Therefore, a table cannot be populated.

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

This information is not provided in the given text.

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)

This information is not provided in the given text. The device is a physical bracket, not an AI diagnostic tool that would typically involve expert ground truth for a test set in the same way.

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

This information is not provided in the given text.

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

This information is not applicable or provided. This device is a physical orthodontic bracket, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.

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

This information is not applicable or provided. As above, this is a physical medical device, not an algorithm.

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

This information is not provided and is likely not relevant in the same way it would be for diagnostic AI. For a physical device, "ground truth" would typically relate to material properties, mechanical integrity, biocompatibility, and intended function verified against engineering standards or clinical benchmarks. The document only mentions "Harmonized Standard".

8. The sample size for the training set

This information is not provided. This device is a manufactured product, not an AI model that undergoes "training" in the same sense.

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

This information is not provided and is not applicable for a physical device in the same way it is for an AI model.

Summary of available information regarding acceptance criteria and study:

Device Name: Orthodontic Ceramic Bracket (ABSOLUTE)
Intended Use: Orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Comparison: Substantially equivalent to SAPPHIRE CERAMIC BRACKET (K073045) ORTHO TECHNOLOGY, INC.
Testing Information: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

Conclusion:

The provided 510(k) summary only offers a very high-level statement about testing being performed according to a "Harmonized Standard" and that the device meets its "design intent." It lacks specific quantitative acceptance criteria, detailed study designs, sample sizes, expert qualifications, or adjudication methods that would be present in a comprehensive study report. This is typical for a 510(k) summary, which is meant to summarize equivalence, not to be a full clinical or engineering study report. For a physical device like an orthodontic bracket, "acceptance criteria" would primarily revolve around mechanical strength, biocompatibility, bond strength, and dimensional accuracy, likely assessed through bench testing and adherence to recognized standards (e.g., ISO standards for orthodontics).

Summary

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K090567

MAY 2 7 2009

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510(K) SUMMARY

[as required by 807':92(c)]

1. Identification of the Device:
  -Proprietary-Trade Name: "Orthodontic Ceramic Bracket (ABSOLUTE)" Star Dentech Korea., Corp.

-Classification Name: bracket, ceramic, orthodontic, Product Code: NJM -Common/Usual Name: Orthodontic Ceramic Bracket / Orthodontic Ceramic Bracket

1. Equivalent legally marketed device:
  This product is similar in design and identical in function to the K073045 / SAPPHIRE CERAMIC BRACKET / ORTHO TECHNOLOGY, INC
1. Indications for Use (intended use):
  Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth
1. Description of the device:
  Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring.

And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.

1. Testing information and Conclusion
  In all material respects, the "Orthodontic Ceramic bracket (ABSOLUTE)" is

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substantially equivalent to SAPPHIRE CERAMIC BRACKET (K073045) ORTHO TECHNOLOGY, INC. Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Star Dentech Korea. Corporation C/O Mr. Brandon Choi General Manager Pats Corporation 49 Candlewood Way Buena Park, California 90621

Re: K090567

Trade/Device Name: Orthodontic Ceramic Bracket Regulation Number: 21 CFR 872,5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: February 14, 2009 Received: March 3, 2009

Dear Mr. Choi:

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. 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.

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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Page 2- Mr. Choi

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Runner

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K090567

Indications for Use

510(k) Number (if known):

Device Name: Orthodontic Ceramic Bracket

Indications for use: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Huly for MSP

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090567

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.