The CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth.

Device Description

The CDB Clip is a passive ligation clip which functions to retain the orthodontic archwire in the slot of an orthodontic bracket. It is made of Celcon MT 24U01 Acetal (POM) with no fillers.

AI/ML Overview

The provided text describes a 510(k) summary for the "CDB Clip - Orthodontic Bracket Accessory". This is a medical device submission, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable or not provided in this type of regulatory document.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Criterion Category	Acceptance Criteria	Reported Device Performance
Intended Use	Same as predicate NEO-CLIP ORTHODONTIC BRACKET ACCESSORY	"The CDB Clip, commonly known as an orthodontic ligation clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth." This matches the description of the predicate's intended use implied by the substantial equivalence claim.
Technological Characteristics	Same as predicate NEO-CLIP ORTHODONTIC BRACKET ACCESSORY (specifically material and overall intended use)	"The function and performance of the CDB Clip is identical to the predicate device listed above. There is no difference in the fundamental technology. The CDB Clip is made of the same material as the predicate device currently on the market and has the same overall intended use." The material is specified as "Celcon MT 24U01 Acetal (POM) with no fillers."
Safety and Effectiveness	No new questions regarding safety and effectiveness compared to the predicate.	"There are no major differences between the CDB Clip and the predicate device cited, therefore, the CDB Clip does not raise any questions regarding the safety and effectiveness. The CDB Clip, as designed, is as safe and effective as the predicate device..."

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

Not Applicable / Not Provided. This document is a 510(k) summary for a Class II orthodontic device. The demonstration of substantial equivalence for such devices typically relies on comparative analysis of design, materials, and intended use with a legally marketed predicate, rather than a clinical performance study with a "test set" as one might find for diagnostic AI software. The claim is that the device is identical in function and performance to the predicate.

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

Not Applicable / Not Provided. See point 2. There was no "ground truth" to establish for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set:

Not Applicable / Not Provided. See point 2.

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 / Not Provided. This device is an orthodontic bracket accessory, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance metrics are irrelevant to this submission.

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

Not Applicable / Not Provided. This is a physical, passive mechanical device, not an algorithm.

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

Not Applicable / Not Provided. The "ground truth" for this submission is essentially the established safety and effectiveness of the legally marketed predicate device (NEO-CLIP ORTHODONTIC BRACKET ACCESSORY, K042905). The applicant is demonstrating that their device is sufficiently similar to that predicate.

8. The sample size for the training set:

Not Applicable / Not Provided. This device is not an AI/ML algorithm that requires a "training set."

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

Not Applicable / Not Provided. See point 8.

Summary

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510(K) SUMMARY

OCT 1 7 2008

Submitter:	CDB Corporation9201 Industrial Blvd.Leland, NC 28451 USAPhone: 910 383-6464Fax: 910 383-6465Contact: Jens RumsfeldTitle: Mgr. Managing Directore-mail: jrumsfeld@cdbcorp.net
Date Prepared:	January 22, 2008
Name of device:	The CDB Clip - Orthodontic Bracket Accessory
Classification Name	Bracket, Ceramic, Orthodontic
Device Classification	Regulatory Class IIProduct Code: NJMClassification Panel: DentalRegulation Number: 21 CFR 872.5470
Predicate Device(s)
510(k) Number	Device	Manufacturer
K042905	NEO-CLIP ORTHODONTICBRACKET ACCESSORY	Dentsply International
Device Description	The CDB Clip is a passive ligation clip which functions to retain theorthodontic archwire in the slot of an orthodontic bracket. It is made ofCelcon MT 24U01 Acetal (POM) with no fillers.
Indications	The CDB Clip, commonly known as an orthodontic ligation clip, is anorthodontic bracket accessory. It attaches to the orthodontic bracket to hold thearchwire firmly in the slot. Together they facilitate the orthodontic movement ofteeth.
Technological Characteristics	The function and performance of the CDB Clip is identical to the predicatedevice listed above. There is no difference in the fundamental technology.The CDB Clip is made of the same material as the predicate device currentlyon the market and has the same overall intended use.

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Conclusion By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device.

There are no major differences between the CDB Clip and the predicate device cited, therefore, the CDB Clip does not raise any questions regarding the safety and effectiveness.

The CDB Clip, as designed, is as safe and effective as the predicate device and the device is determined to be substantially equivalent to the referenced predicate device currently on the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2008

Mr. Jens Rumsfeld Managing Director CDB Corporation 9201 Industrial Boulevard Leland, North Carolina 28451

Re: K080906

Trade/Device Name: CDB Clip Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: September 12, 2008 Received: September 16, 2008

Dear Mr. Rumsfeld:

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 such 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. Rumsfeld

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Th. Spraguelsted, m.D. for "

Chiu S. Lin, Ph. D Division 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): K080906

Device Name: CDB Clip

Indications For Use:

Susan Punaes

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

510(k) Number: K080996

Prescription Use X (Part 21 CFR 80'1 Subpart D) ANDIOR

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 (OD E)

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.