These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.

These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.

Device Description

The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.

These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.

These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for "Ceramic Brackets" (K110335). This document is a regulatory submission for a medical device and thus does not include the type of detailed study information (sample size, ground truth, expert qualifications, etc.) that would be found in a clinical trial or performance study report for an AI/CAD system.

The document asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics. Therefore, many of the requested categories of information are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't present "acceptance criteria" in the sense of predefined thresholds for sensitivity, specificity, F1-score, or similar performance metrics typically associated with AI/CAD systems. Instead, the "acceptance criteria" for this type of submission are based on demonstrating "substantial equivalence" to existing legally marketed predicate devices.

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance (as stated by Ortho Organizers Inc.)
Intended Use: Must be equivalent to predicate devices (for correction of orthodontic malocclusions).	"intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter the tooth's position" - Equivalent to predicate.
Bracket Body Material: Must be equivalent to predicate devices.	"99.9% Polycrystalline aluminum oxide" - Equivalent to predicate.
Pad Coating Material: Must be equivalent to predicate devices.	"Irregular Microcyrstalline Aluminum Oxide" - Equivalent to predicate.
Biocompatibility: Must be equivalent to predicate devices.	"Yes" - Equivalent to predicate.
Single Use: Must be equivalent to predicate devices.	"Yes" - Equivalent to predicate.
Non-Sterile packaging: Must be equivalent to predicate devices.	"Yes" - Equivalent to predicate.
Color-coded indicator for bracket identification: May have minor differences.	"Yes, optional" for Ortho Organizer vs. "Yes" for predicate. This minor difference does not raise new safety or effectiveness concerns (Equivalent).
No new types of safety and effectiveness questions raised.	"Descriptive and performance testing demonstrate substantial equivalence." (General statement, no specific safety/effectiveness metrics provided).

2. Sample size used for the test set and the data provenance:

Not Applicable. This document does not describe a performance study with a "test set" in the context of AI/CAD system evaluation. The assessment is based on material properties, intended use, and design features compared to predicate devices.
The "performance testing" mentioned is likely mechanical and material testing to ensure the bracket meets engineering specifications, not a clinical trial or diagnostic accuracy study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No "ground truth" establishment by experts is described for this type of medical device. The "truth" is established by the known performance and safety profiles of the predicate devices and the physical/chemical identicality or similarity of the new device.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication method as described for AI/CAD systems.

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 physical medical device (orthodontic bracket), not an AI/CAD system or a diagnostic imaging tool that would involve human readers.

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

Not Applicable. This is a physical medical device.

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

Not Applicable. The "ground truth" for this submission method is effectively the established safety and efficacy of the predicate devices, against which the new device is compared in terms of its material, design, and intended use.

8. The sample size for the training set:

Not Applicable. This document does not describe the development or training of an AI algorithm.

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

Not Applicable. This document does not describe the development or training of an AI algorithm.

Summary

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K110335

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MAY 1 9 2011

5.510(k) Summary

: .

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K110335

510k Summary

Device Name:

Ceramic Brackets

Submitter's Name, address, telephone number, contact person, and date the summary was prepared:

Submitter's Name:	Ortho Organizers Inc.
Submitter's Address:	1822 Aston Ave. Carlsbad, CA 92008
Submitter's Telephone:	760-448-8600
	760-448-8613 fax
Submitter's Contact:Assurance	Foster Boop, Director of Regulatory Affairs and Quality
Email:	Foster.Boop@OrthoOrganizers.com
	Ph. 760-448-8600 ext 146

Date 510(K) Summary Prepared: January 31, 2011

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Proprietary Name:	Undetermined
Common or Usual Name:	Ceramic Brackets
Classification Name:	Bracket, Ceramic, Orthodontic
Classification Code:	NJM

Identification of Legally Marketed Device: (Device Equivalence)

Proprietary Name:	Transcend Ceramic Brackets
510K Number:	K861965
Common or Usual Name:	Ceramic Brackets
Classification Name:	Bracket, Ceramic, Orthodontic
Classification Code:	DYW
Device Manufacturer:	3M-Unitek Corp.

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Proprietary Name:	Transcend Ceramic Brackets
510K Number:	K944286
Common or Usual Name:	Ceramic Brackets
Classification Name:	Bracket, Ceramic, Orthodontic
Classification Code:	DYW
Device Manufacturer:	3M-Unitek
Proprietary Name:	Clarity Modified Ceramic Bracket
510K Number:	K062305
Common or Usual Name:	Ceramic Brackets
Classification Name:	Bracket, Ceramic, Orthodontic
Classification Code:	NJM
Device Manufacturer:	3M-Unitek

Description of the Device:

The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.

Intended Use:

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Summary of the technological characteristics of the device compared to the predicate devices:

The Ortho Organizer Ceramic Bracket System is substantially equivalent to the 3M Unitek Ceramic Bracket System. Table 1 summarizes the technological characteristics of this equivalence:

Table 1.

ProductParameter	Bracket	Predicate Product:3M Unitek Transcendand Clarity*	Ortho Organizer'sceramic brackets	SubstantialEquivalence Analysis
510k Number	All	K861965, K944286,K062305	Pending	N/A
Intended useper 872.5470	All	intended to bebonded to a tooth toapply pressure to atooth from a flexibleorthodontic wire toalter the tooth'sposition	intended to bebonded to a tooth toapply pressure to atooth from a flexibleorthodontic wire toalter the tooth'sposition	Equivalent
Bracket BodyMaterial	All	99.9% Polycrystalline:aluminum oxide	99.9% Polycrystallinealuminum oxide	Equivalent
Pad CoatingMaterial	All	IrregularMicrocyrstallineAluminum Oxide	IrregularMicrocyrstallineAluminum Oxide	Equivalent
Biocompatibility	All	Yes	Yes	Equivalent
Single Use	All	Yes	Yes	Equivalent
Non-Sterilepackaging	All	Yes	Yes	Equivalent
Color codedindicator forbracketidentification	All	Yes	Yes, optional	Equivalent

A claim of Substantial Equivalence to the 3M Unitek Ceramic Bracket system is not made for the metal insert feature available in this product line. The Transcend Bracket, like the Ortho Organizer Ceramic Bracket, does not include this feature.

Conclusion:

The Ortho Organizer Ceramic Bracket System has the same intended use and similar technological characteristics as the predicate device. The minor differences in technological characteristics do not raise new types of safety and effectiveness questions. Descriptive and performance testing demonstrate substantial equivalence.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.

MAY 1 9 2011

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

Mr. Foster Boop Director of Regulatory Affairs and Quality Ortho Organizers, Incorporated 1822 Aston Avenue Carlsbad, California 92008-7603

Re: K110335

Trade/Device Name: Ceramic Brackets Impression Compound Regulation Number: 21 CFR 872.5470 Regulation Name: Plastic Orthodontic Bracket Regulatory Class: II Product Code: NJM Dated: January 31, 2011 Received: February 15, 2011

Dear Mr. Boop:

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. Boop

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/ ucm 1 1 5809.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/ReportaProblem/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 yours,

Wh 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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Indications for Use

510(k) Number (if known):

Device Name: Ceramic Brackets

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE).

Susan Rummer

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

510(k) Number: K110335

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.