CDB Self Ligating Bracket 8F by CDB CORPORATION

CDB Self Ligating Bracket 8F is bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (CDB Self Ligating Bracket 8F), which primarily demonstrates substantial equivalence to existing predicate devices rather than proving independent performance against acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and the study that proves the device meets them, especially in the context of an AI/algorithm-driven device.

Here's why and what information is available:

Type of Device: The CDB Self Ligating Bracket 8F is an orthodontic bracket, a physical medical device. It is not an AI or algorithm-driven diagnostic or therapeutic device. The performance testing conducted is engineering-focused (e.g., comparative shear bond strength testing), not clinical performance metrics like sensitivity, specificity, or reader improvement.
Regulatory Pathway: A 510(k) submission establishes substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and is as safe and effective as the predicate. It usually does not require a full de novo clinical performance study against pre-defined acceptance criteria for diagnostic accuracy, as would be expected for an AI device.

However, based on the limited information about "performance testing" provided, here's what can be extracted, reformatted to align with your request, but emphasizing the lack of clinical study data for AI:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's limited scope):

Acceptance Criterion	Description from Document (Inferred)	Reported Device Performance (from Document)
Bond Strength	The device's bond strength should be as strong as or stronger than the primary predicate device (Dentsply In-Ovation C) to ensure secure attachment to teeth during orthodontic treatment and comparable material performance. This is critical for function and patient safety.	"Comparative shear bond strength testing was conducted to the noted predicate device and that the results demonstrated that the bond strength was as strong as the predicate."
Functional Equivalence	The device's function, performance, and contact material should be similar to the predicate device, with minor design changes not impacting safety or effectiveness. The principles of operation (wire ligation) should be consistent with the predicate.	"The function, performance, and contact material of the CDB Self Ligating 8F is similar to the predicate." "The wire is held in a passive, interactive, or active state by the clip. The clip slides into and out of place to ligate the wire." (Identical description for both device and predicate).
Material Composition Equivalence	The material composition, especially for components that contact the patient, should be substantially equivalent to, or well-established through, predicate or reference devices to demonstrate biocompatibility and performance.	Bracket Composition: Aluminum Oxide (Predicate: Aluminum Oxide, Silicon Dioxide)
		Clip Material: Nickel Titanium (Predicate: Manganese, Nickel, Chromium, Molybdenum, Niobium, Titanium, Iron, Cobalt; Reference devices: Nickel Titanium)
		Clip Coating: Gold Rhodium (Identical for both device and predicate)
Intended Use Equivalence	The indications for use should be the same as the predicate device.	"The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid." (Identical to predicate's intended use).

Regarding the other requested points (which are highly relevant to AI/algorithm studies but not explicitly described for this physical device's 510(k) submission):

Sample size used for the test set and the data provenance: Not applicable in the context of this device's "performance testing." The "comparative shear bond strength testing" likely involved a certain number of brackets tested in a lab, but the document does not specify the sample size or provenance of "data" in the sense of clinical cases for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthodontic bracket's performance is typically established through engineering standards and physical measurements, not expert clinical interpretation of images or patient outcomes for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "performance testing," the ground truth was likely engineering measurements (e.g., force required to shear the bond).
The sample size for the training set: Not applicable. There is no AI model or "training set" for this physical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (orthodontic bracket) under the 510(k) pathway, focusing on demonstrating equivalence to predicate devices rather than a clinical trial proving performance against predefined clinical acceptance criteria for an AI or diagnostic algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white 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 image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

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

September 27, 2016

CDB Corporation Yannire Thompson Quality & Regulatory Affairs Manager 9201 Industrial Boulevard, NE Leland. North Carolina 28451

Re: K160957

Trade/Device Name: CDB Self Ligating Bracket 8F Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: August 31, 2016 Received: September 1, 2016

Dear Yannire Thompson:

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.

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

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K160957/S002

Device Name: CDB Self Ligating Bracket 8F

Indications for Use:

The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.

AND/OR

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

Prescription Use ਡ (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for Ceramic Dental Brackets. The logo consists of the letters "cdb" in a stylized font, with the top half of the letters in a lighter blue and the bottom half in a darker blue. Below the letters, the words "CERAMIC DENTAL BRACKETS" are written in a smaller, gray font.

510(k) Summary

Submitter:	CDB Corporation9201 Industrial Blvd, NELeland, NC 28451 USAPhone: 910-383-6464Fax: 888-280-1556Contact: Yannire ThompsonTitle: Quality/Regulatory Affairs ManagerEmail: ythompson@cdbcorp.net
Date Prepared:	September 16th, 2016
Name of Device:	CDB Self Ligating Bracket 8F
Common Name:	Self Ligating Bracket
Classification Name:	Bracket, Ceramic, Orthodontic
Device Classification:	Regulatory class IIProduct code: NJMClassification Panel: DentalRegulation Number: 872.5470
Primary Predicate Device:	Company Dentsply Int.	Product In-Ovation C	510(k) K060837
Device Description:	CDB Self Ligating Bracket 8F is bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket.
Indications:	The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.

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Image /page/4/Picture/0 description: The image shows a logo for "CDB CERAMIC DENTAL BRACKETS". The logo is in blue and consists of the letters "CDB" stacked on top of each other. The top half of the letters are a lighter blue, while the bottom half is a darker blue.

Technical Characteristics:	The function, performance, and contact material of the CDB Self Ligating 8F is similar to the predicate. Minor design changes are the only modifications made to the In-Ovation C (K06083).
	There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in legally marketed devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets In-Ovation C (K060837).
Performance Testing:	Comparative shear bond strength testing was conducted to the noted predicate device and that the results demonstrated that the bond strength was as strong as the predicate.
Physical Properties,Materials, Intended useComparison:	The CDB Self Ligating Bracket 8F is identical in use, contact material type, manufacturing methods (injection molding, sintering, stamping, and plating), and duration of patient contact as the primary predicate device In-Ovation C (K060837).
	FDA requested to include here a table, similar to the one provided in the biocompatibility section, which compares the physical properties, materials, and intended use of The CDB Self Ligating Bracket 8F to the designated primary predicate device. Please find below a comparison for the primary predicate and the CDB Self Ligating Bracket 8F:

CDB Corporation 510(k) Submission

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Image /page/5/Picture/0 description: The image is a logo for Ceramic Dental Brackets. The logo is made up of the letters "cdb" in a stylized font. The top half of the letters are blue, and the bottom half are a darker blue. Below the letters, the words "CERAMIC DENTAL BRACKETS" are written in a smaller, gray font.

Property	CDB Self Ligating Bracket 8F	Primary PredicateDentsply InOvation C
Bracket Composition:	Aluminum Oxide	Aluminum OxideSilicon Dioxide
Clip Material:	NickelTitanium	ManganeseNickelChromiumMolybdenumNiobiumTitaniumIronCobalt
	Clip Coating:	GoldRhodium	GoldRhodium
		Intended Use:	Indicated for orthodontic movement ofuncompromised natural teeth, excludingmandibular bicuspids.
	Principles of Operation:	The wire is held in a passive, interactive, oractive state by the clip. The clip slides intoand out of place to ligate the wire.	The wire is held in a passive, interactive, oractive state by the clip. The clip slides intoand out of place to ligate the wire.
	Aesthetic Features	Clear (translucent) bracket system	Clear (translucent) bracket system
	Physical properties	Mechanical retention	Mechanical retention
	Application	Bonded	Bonded
	Manufacturing Method	Injection molding	Injection molding
Contact Classification	Permanent surface contacting device whichcontacts the mucosal membrane	Permanent surface contacting device whichcontacts the mucosal membrane
Color Additives	None	Unknown

CDB Corporation 510(k) Submission

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Image /page/6/Picture/0 description: The image is a logo for "CERAMIC DENTAL BRACKETS". The logo consists of the letters "cdb" in a stylized font, with the top half of the letters in a lighter blue and the bottom half in a darker blue. The words "CERAMIC DENTAL BRACKETS" are written in a smaller font below the letters.

FDA requested to provide the name of another predicate device that has the same chemical composition as CDB Self Ligating Bracket 8F clip material. Please see below for two reference devices:
Click-it (K111234) by TP Orthodontics. Click-it is a self ligating ceramic bracket with a Nickel titanium clip.
Clarity SL (K062345) by 3M Unitek. Clarity SL is a self ligating ceramic bracket with a Nickel titanium clip.
Conclusion:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate devices.
There are no major differences between the CDB Self Ligating Bracket 8F and the predicate device cited; therefore the CDB Self Ligating Bracket 8F, as designed, is determined to be substantially equivalent to the referenced primary predicate device and reference devices currently on the market.

CDB Corporation 510(k) Submission

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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.