Composite brackets provide a clear, aesthetic option for patients undergoing orthodontic treatment. The Composite Bracket system is designed to provide simple, aesthetic bonded brackets to correct minor to complicated mal-alignments in patients with permanent dentition (second molars) or mixed dentition using current orthodontic diagnosing techniques with orthodontic arch wires. The system consists of a series of clear, plastic brackets that conform to each tooth and its anatomy and adheres with a bracket base bearing a mechanical retention surface. They are provided with or without a metal archwire slot. Additional accessories to the brackets, depending on the dental professionals' technique, mav include small hooks for the use of elastics and auxiliary arch wire tubes. Each bracket applies incremental, progressive force to reposition teeth to achieve ideal alignment, as prescribed by the treating dental practitioner. The composite brackets are bonded to the patient's teeth by traditional orthodontic direct and indirect bonding techniques using Orthodontic adhesives.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Composite Brackets" by Ortho Specialties, Incorporated. This document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML-driven device with acceptance criteria and a study proving performance against those criteria in the typical sense of AI model evaluation.

Therefore, many of the requested sections about AI study specifics cannot be answered from the provided text. I will extract the information that is present.

This document is a 510(k) premarket notification for a medical device called "Composite Brackets." It is a regulatory filing to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study evaluating the performance of an AI/ML algorithm. As such, the typical acceptance criteria and study design for AI models (e.g., sensitivity, specificity, ROC curves, human reader improvement) are not applicable here.

However, I can extract information related to the device's characteristics and the biological evaluation studies performed for regulatory clearance.

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

Since this is not an AI/ML algorithm evaluation, there are no "acceptance criteria" in the traditional sense of performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the biological safety tests and the claim of substantial equivalence to predicate devices based on technological characteristics.

Property	Acceptance Criteria (Implied)	Reported Device Performance (Composite Brackets)
Cytotoxicity (ISO 10993-5 Elution Method)	No evidence of cell lysis or toxicity, grade less than 2	Showed no evidence of causing cell lysis or toxicity; met requirements with a grade of less than 2 (Mild reactivity).
Oral Mucosal Irritation (ISO 10993-10)	Considered a non-irritant to oral mucosa	Considered a nonirritant to the oral mucosa of the hamster.
Technological Equivalence	Similar intended use, composition, aesthetics, physical properties, application, and manufacturing method to predicate devices (Dentsply Elation MB and CDB Reflections)	Demonstrated similar intended use, composition (Polycarbonate), aesthetic features (Clear/translucent), mode of use (Archwire implementation), application (Bonded), and manufacturing method (Molded, thermo-formed).
Physical Properties	Similar shear bond and compressive strength to predicate devices	Physical property testing showed similar shear bond and compressive strength to predicate devices. (Specific values not provided in this summary.)

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

Cytotoxicity Test: The ISO 10993-5 Elution Method involves in vitro mammalian cell culture. The sample size refers to the number of cell cultures or replicates tested, which is not specified but follows ISO guidelines. Data provenance is implied by adherence to ISO standards.
Oral Mucosal Irritation Test: Performed in hamsters. The number of hamsters (sample size) is not specified but follows ISO 10993-10 guidelines. Data provenance is implied by adherence to ISO standards.
Technological Equivalence Comparison: This is a comparison of device characteristics against predicate devices, not a test with a "test set" of patient 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 to this type of device and study. The "ground truth" for the biological evaluations is determined by the standardized test methods outlined in the ISO standards. The evaluation of technological equivalence is a comparison of product specifications by regulatory professionals and engineers.

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

Not applicable. The biological tests follow standardized laboratory protocols. The comparison to predicate devices is a regulatory assessment.

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 document is for an orthodontic bracket, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm.

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

Cytotoxicity: The "ground truth" is defined by the cellular response to the eluted materials as per ISO 10993-5 (e.g., cell viability, morphological changes indicating toxicity).
Oral Mucosal Irritation: The "ground truth" is based on observed inflammatory responses in the hamster oral mucosa as per ISO 10993-10 (e.g., erythema, edema).
Technological Equivalence: The "ground truth" for comparison is the documented characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

November 12,2014

Ortho Specialties, Incorporated C/O Ms. Paula Wendland Regulatory Affairs Consultant 207 Pheasant Meadow Court Gurnee, IL 60031

Re: K140807

Trade/Device Name: Composite Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: September 22, 2014 Received: October 1, 2014

Dear Ms. Wendland:

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 - Ms. Wendland

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/0 description: The image contains a logo for "Ortho Specialties". The logo features the letters "OS" in a stylized font, with horizontal lines running through them. To the right of the letters, the words "ORTHO" and "SPECIALTIES" are stacked on top of each other in a bold, sans-serif font.

SECTION 6.0 INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): _ K140807

Device Name:

Indications for Use:

The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Image /page/3/Picture/0 description: The image is a logo for "Ortho Specialties". The logo features the letters "OS" in a stylized font, with horizontal blue lines running through them. To the right of the letters, the words "Ortho Specialties" are written in a simple, sans-serif font, also in blue. A thin blue line runs along the bottom of the logo.

Section 5.0 510 (k) Summary

Note: This summary is provided in accordance with 21CFR807.92(c).

510(k) Owners Name:	Ortho Specialties, Inc.Tim Allesee, President/Owner
Address:	3820 Ohio Ave. Suite 15Saint Charles, IL 60174 USA
Contact Phone Number:	224-420-0125
Fax Number:	630-443-0224
Contact Person:	Paula Wendland, Regulatory Affairs Consultant (Preparer)

Date 510(k) Summary was Prepared: March 22, 2014

Medical Device Name:

Trade name Composite Brackets .
Common name Plastic Orthodontic Brackets .
Classification name -orthodontic plastic bracket (21CFR872.5470, Product . Code DYW, Class II Device)

LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:

Elation MB TM by Dentsply/GAC, Inc. K092030 ●
CDB Reflections Composite Bracket System, K973776 .

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Image /page/4/Picture/0 description: The image shows the logo for "Ortho Specialties". The logo consists of the letters "OS" stacked on top of each other on the left side of the image. The letters are made up of horizontal blue lines. To the right of the letters is the text "Ortho Specialties" in blue font.

5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

Removal method of the composite brackets at the conclusion of treatment is consistent with standard bracket removal methods reported in orthodontic literature and require no additional instructions. The removal method is identical to those required for the predicate device.

The Composite Brackets will be marketed in bulk (for up to 5 full arches) using a circular tray dispenser with identification key for each bracket type and tooth position. The Composite brackets are also available in a clear, plastic tray for a single patient arch.

5.2 INTENDED USE AND POPULATION:

The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.

5.3 PREDICATE DEVICE:

Dentsply Elation MB bracket system, 510(k) submission (K092030) dated 7/24/2009 is similar in intended use and compositional technology compared to the Composite Brackets described in this submission for brackets with metal reinforced slots.

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Image /page/5/Picture/0 description: The image shows the logo for Ortho Specialties. The logo consists of the letters "OS" in a stylized font, with the letters made up of horizontal blue lines. To the right of the letters, the words "ORTHO SPECIALTIES" are written in blue, with "ORTHO" on top of "SPECIALTIES". A blue line is present at the bottom of the logo.

CDB Reflections Composite bracket system, 510(k) submission (K973776), dated 11/21/1997 is similar in intended use compared to Composite Brackets described in this submission for brackets that do not contain metal reinforced slots.

5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:

Performance Characteristics of COMPOSITE BRACKETS versus GAC Elation MB and CDB Reflections:

Property	CompositeBrackets	GAC Elation MB	CDB Reflections
Intended Use	Plastic, OrthodonticBracket with orwithout metalreinforced slots foralignment of teeth	Plastic, OrthodonticBracket with metalreinforced slots foralignment of teeth	Plastic, OrthodonticBracket withoutmetal reinforcedslots for alignmentof teeth
Composition	Polycarbonate	Polycarbonate	Polycarbonate
AestheticFeatures	Clear (translucent)bracket system	Clear (translucent)Bracket System withreinforced metalslots	Clear (translucent)bracket system
Mode of Use	Archwireimplementation bydentalprofessional'stechnique	Archwireimplementation bydental professional'stechnique	Archwireimplementation bydental professional'stechnique
PhysicalProperties	MechanicalRetention baseeliminating needfor plasticcondition pre-treatmentNon-Toxic ink onbrackets foridentification	MechanicalRetention baseeliminating need forplastic condition pre-treatmentNon-Toxic ink onbrackets foridentification	Base requires PlasticConditioner prior tobonding with anorthodontic adhesive.Non-Toxic ink onbrackets foridentification
Application	Bonded	Bonded	Bonded
ManufacturingMethod	Molded, thermo-formed	Molded, thermo-formed	Molded, thermo-formed

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Image /page/6/Picture/0 description: The image shows the logo for "Ortho Specialties". The logo consists of the letters "OS" stacked on top of each other, with the "O" on top and the "S" on the bottom. The letters are made up of horizontal blue stripes. To the right of the letters is the text "ORTHO SPECIALTIES" in blue, with "ORTHO" on top and "SPECIALTIES" on the bottom.

5.5 Summary:

Composite Brackets of thermoplastic polycarbonate composition have been well documented in literature (Pithon M., Lacerda dos Santos R., Martins F., Ruellas A., Nojima L., Nojima M., Romanos, M. (2009) Cytotoxicity of Polycarbonate Orthodontic Brackets, Brazilian Journal of Oral Science, April/June 2009 -Volume 8, Number 2).

Cytotoxicity testing was conducted using the ISO 10993-5 Elution Method. The Composite Orthodontic Brackets were evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test following the guidelines of ISO10993-5, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity. The Composite Orthodontic Brackets showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity).

Oral Mucosal irritation testing was conducted using ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The Composite Orthodontic Brackets were evaluated for potential to cause oral mucosal irritation in hamsters. The Composite Orthodontic Brackets were considered a nonirritant to the oral mucosa of the hamster.

Based on characteristics of intended use, application, composition, aesthetics and physical property testing showing similar shear bond and compressive strength, the Composite brackets are substantially equivalent to the predicate devices (Dentsply Elation MB and CDB Reflections Composite bracket systems).

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.