MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

AI/ML Overview

The provided text describes a 510(k) submission for the MISO Translucent Orthodontic Bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and study details for a medical device AI/software will not be present in this document.

Here's the breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify general "acceptance criteria" in the typical sense of a target performance metric for AI/software (e.g., sensitivity, specificity). Instead, it compares the technical characteristics of the proposed device with predicate devices. The key performance characteristic mentioned for the device itself is Bond Strength.

Characteristic	Acceptance Criteria (from predicate/standard)	Reported Device Performance (MISO)
Bond Strength (MPa)	$5.51 \pm 1.65$ (Predicate 1 - Absolute) $19.41 \pm 5.08$ (Predicate 2 - Sapphire Ceramic Bracket)	$11.73 \pm 3.04$
Material	Alumina (mono crystal ceramic bracket)	Alumina (mono crystal ceramic bracket)
Translucent	Yes	Yes
Standards	ISO 10993, ISO 11405:2003	ISO 10993, ISO 11405:2003
Biocompatibility	Yes	Yes
Available Slot Sizes	0.018/0.022 inch	0.018/0.022 inch
Available Prescriptions	Roth/MBT/Edgewise	Roth/MBT/Edgewise

Note on "Acceptance Criteria": The document implies that demonstrating comparable or superior performance (within acceptable variations) to the predicate devices, especially regarding bond strength, and adherence to relevant ISO standards, serves as the basis for establishing "substantial equivalence." The predicate device's bond strengths ($5.51 \pm 1.65$ MPa and $19.41 \pm 5.08$ MPa) could be interpreted as the "acceptance range" or reference points for demonstrating equivalence. The MISO device's bond strength ($11.73 \pm 3.04$ MPa) falls within the range of the predicate devices.

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

The study described is not a clinical AI/software validation; it's a materials testing study.

Sample Size: Not explicitly stated for bond strength testing, other than "results are detailed in Section 12" which is not provided.
Data Provenance: Not applicable as it's a material property test, not patient data.

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

Not applicable. Ground truth for material bond strength is established through laboratory measurement, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable.

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 is a material properties submission, not an AI/software device.

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

Not applicable. This is a material properties submission, not an AI/software device.

7. The Type of Ground Truth Used

Ground Truth Type: Laboratory measurements of material properties, specifically "Bond strength testing was carried out according to ISO 11405-2003(E)."

8. The Sample Size for the Training Set

Not applicable. This is a material properties submission for a physical device, not an AI model.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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K102561

5. 510(k) Summary

(per 21 CFR 807.92)

JAN 2 5 2011

I. Applicant

Name : HT Co., Ltd. Address : HBI 513, Hanyang Univ., 1271, Sa3-dong, Ansan-si, Gyeonggi-do. 426-791. Korea

Contact Person: Jerry Choi Manager (Tel : 82-31-400-3932 Fax : 82-31-418-2803)

Date Prepared: Sep 6th , 2010

II. Device Name

Proprietary Name: Common/ Usual Name: Classification Name: Regulation Number: Product Codes: Classification: Classification Panel:
MISO Translucent Orthodontic Bracket Orthodontic Plastic(Ceramic) Bracket Orthodontic appliance and accessories 21CFR872.5470 NJM II Dental

III. Predicate Device

MISO Translucent Orthodontic bracket is substantially equivalent to the Absolute bracket from Star Dentech Korea, Corp. and the Pure bracket from Ortho Technology. The Absolute bracket was most recently cleared.by the FDA on May 27, 2009 under 510(k) K090567. The Pure bracket was cleared by the FDA on December 18, 2007 under 510(k) K073045.

IV. Indications for use statement

MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

V. Description of the Device

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VI. Summary of the Technical Characteristics

MISO Translucent Orthodontic Bracket was designed and tested using the following standard: .

ISO 11405:2003 Dental materials -- Testing of adhesion to tooth . structure

VII. Conclusion of Safety & Effectiveness

There are no known substantial differences between the bracket defined in this 510(k) submission and the predicate devices. They have the same intended use and any differences in technological characteristics do not raise issues of safety and effectiveness.

Company	Star Dentech	Ortho Technology(OEM : Hubit)	HT Co., Ltd
Product Name	Absolute	Sapphire Ceramic Bracket	MISO
510(k) Number	K090567	K073045
Product Code(s)	NJM	NJM	NJM
Regulation #	21CFR872.5470	21CFR872.5470	21CFR872.5470
Class	II	II	II
Intended Use	Movement of teeth	Movement of teeth	Movement of teeth
Material	Alumina(mono crystal	Alumina(mono crystal	Alumina(mono crystal
Composition	ceramic bracket)	ceramic bracket)	ceramic bracket)
Translucent	Yes	Yes	Yes
Standards	ISO 10993	ISO 10993	ISO 10993
Biocompatibility	Yes	Yes	Yes
Available Slot Sizes	0.018 /0. 022 inch	0.018 /0. 022 inch	0.018 /0. 022 inch
Available	Roth / MBT / Edgewise	Roth / MBT / Edgewise	Roth / MBT / Edgewise
Prescriptions
Bond Strength*(MPa)	$5.51 \pm 1.65$	$19.41 \pm 5.08$	$11.73 \pm 3.04$

Bond strength testing was carried out according to ISO 11405-2003(E). Results are detailed in Section 12.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jerry Choi Manager HT Company, Limited HBI 513, Hanyang Univ., 1271, Sa3-dong Ansan-si, Gyeonggi-do 426-791, Korea

JAN 2 5 301

Re: K102561

Trade/Device Name: MISO Translucent Orthodontic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthondontic Appliance and Accessories Regulatory Class: II Product Code: NJM Dated: January 13, 2011 Received: January 13, 2011

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. 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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hh for

Anthony D. Watson, B.S., M.S., M.B.A. . 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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K102561

4. Indication for Use Statement

510(k) Number (if known): K102561

Device Name: MISO Translucent Orthodontic Bracket

Indications for Use:

MISO Translucent Orthodontic Bracket is 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)

Concurrence of CDRH-Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K102561
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Page 1 of 1

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.