The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon FT appliance has both aesthetic and self-ligating qualities. The Damon FT bracket is designed to 1) increase patient comfort, with its increased corner radius. 2) enhance bracket placement, with its rhomboid design, and 3) improve overall bracket performance without changing treatment mechanics, with its metal archwire slot, rotation control similar to Damon 2 bracket, and compatibility with the Damon 2 bracket.

AI/ML Overview

This submission from Sybron Dental Specialties, Inc. (K032408) is a 510(k) premarket notification for a new medical device, the Damon FT orthodontic bracket. This type of submission relies on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than extensive clinical studies to prove effectiveness and safety from scratch.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific performance metrics, or a study design (sample size, expert ground truth, adjudication, MRMC studies, standalone performance) that would be present in a PMA (Premarket Approval) application or a clinical trial report for a novel, higher-risk device.

Here's an breakdown of the information that can be extracted, and where the requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in this document. The concept of "acceptance criteria" for specific performance metrics (like accuracy, sensitivity, specificity, etc.) is typically associated with studies designed to quantify a device's performance against predefined targets. This 510(k) submission focuses on demonstrating substantial equivalence in function and safety to an existing device rather than presenting novel performance data against specific quantitative acceptance criteria.

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

Not applicable / Not provided. A "test set" in the context of device performance evaluation (e.g., for AI algorithms) is not relevant here. This submission relies on comparing the design and intended use of the Damon FT bracket to a predicate device. No new clinical performance or efficacy study using a "test set" of patients or data is presented.

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

Not applicable / Not provided. Ground truth establishment is relevant for studies where expert interpretation or diagnosis is being evaluated (e.g., in medical imaging AI). This submission is for an orthodontic bracket, and no such study is described.

4. Adjudication Method for the Test Set

Not applicable / Not provided. Adjudication methods are used in studies involving multiple readers to resolve discrepancies in interpretation. This is not pertinent to the 510(k) submission for an orthodontic bracket and its demonstration of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is a specific type of clinical trial often used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance across multiple cases. This is not relevant to an orthodontic bracket and its mode of a 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. "Standalone performance" refers to the performance of an algorithm or AI system without human intervention. This device is a physical orthodontic bracket, not an algorithm.

7. The Type of Ground Truth Used

Not applicable / Not provided. As no performance study with a "test set" is described, the concept of "ground truth" (e.g., pathology, expert consensus) does not apply here. The submission primarily relies on comparing the physical characteristics and intended use of the new bracket to a predicate device.

8. The Sample Size for the Training Set

Not applicable. A "training set" is used in the development of AI algorithms. This device is a physical orthodontic bracket, not an AI or software device that would require training data.

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

Not applicable. As there is no training set for an AI algorithm discussed, this question is not relevant.

Summary of What the Document DOES Provide:

Device Name: Damon FT
Device Type: Plastic Orthodontic Bracket
Intended Use: Movement of teeth during orthodontic treatment.
Predicate Device: Spirit MB bracket marketed by Ormco Corporation.
Basis for Equivalence: Similar function and intended use; it's a polycarbonate bracket with aesthetic and self-ligating qualities. It's designed to increase patient comfort, enhance bracket placement (rhomboid design), and improve overall bracket performance without changing treatment mechanics (metal archwire slot, rotation control similar to Damon 2, compatibility with Damon 2).
Regulatory Decision: Substantially equivalent to existing legally marketed devices.

This 510(k) framework specifically bypasses the need for extensive de novo clinical studies demonstrating device performance against specific metrics by showing that the new device is as safe and effective as a device already on the market.

Summary

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K032408

OCT 1 5 2003

S< ction III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

August 2003 Date Summary Prepared:

I Device Name:

Trade Name Damon FT (
1 : Common Name - Plastic Orthodontic Bracket
Classification Name Bracket, Plastic, Orthodontic, per 21 CFR § 872.5470 :

Devices for Which Substantial Equivalence is Claimed:

D Orinco Corporation, Spirit MB

Device Description:

Intended Use of the Device:

The intended use of Damon FT is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

Substantial Equivalence:

Damon FT is substantially equivalent to other legally marketed devices in the United States. Damon FT functions in a manner similar to and is intended for the same use as the Spirit MB bracket marketed by Ormco Corporation.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Mr. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032408

Trade/Device Name: Damon FT Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: August 1, 2003 Received: August 4, 2003

Dear Mr. Boswell:

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. Boswell

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 (OS) 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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Clufs

Chiu Lin. Ph.D. 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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Se :tion I - Indications for Use

Ver/ 3 - 4 '24/96 Applicant: Ormco Corporation 032408 510(k) Number (if known): __ Device Name. Damon FT Indicat ons For Use: Damor FT is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment. Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:_ 1 12 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.