The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon 3 Modified mandroum orders stemic and self-ligating qualities. The Damon 3 Modified bracket was appliance has bour acthe reinforcement of the metal assembly to the molded plastic body, to enhance the strength of the bracket against the over-travel of the metal slide and to improve the ease of its opening and closing mechanisms.

AI/ML Overview

This looks like a 510(k) summary for a medical device (orthodontic bracket), which typically does NOT include detailed performance studies or acceptance criteria in the same way an AI/software device would. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance data.

Therefore, for your request, much of the information you've asked for is not present in the provided text, as it's not a performance study report for a new device, but rather a regulatory submission for equivalence.

However, I can extract the relevant information and explicitly state what is missing based on the document.

Acceptance Criteria and Device Performance Study (Based on Provided Text)

This 510(k) submission for the Damon 3 Modified orthodontic bracket does not present a performance study with detailed acceptance criteria and quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Ormco Corporation's Damon 3).

The primary "acceptance criterion" for this type of submission is the FDA's determination that the new device is substantially equivalent to a predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary of Equivalence Claims)
Intended Use Equivalence: Same intended use as the predicate device.	Intended Use: "The intended use of Damon 3 Modified is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment." This is stated to be "identical to" the original Damon 3 bracket.
Technological Characteristics Equivalence: Similar materials, design, mechanism of action.	Device Description: "The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon 3 Modified appliance has four reinforcement of the metal assembly to the molded plastic body, to enhance the strength of the bracket against the over-travel of the metal slide and to improve the ease of its opening and closing mechanisms." The device "functions in a manner identical to" the original Damon 3.
Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness.	The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies the FDA found no new questions of safety or effectiveness.

Detailed Information Not Applicable/Present in this 510(k) Summary:

Due to the nature of a 510(k) for substantial equivalence of a physical medical device (orthodontic bracket), the following points are generally not part of the submission in the way they would be for an AI/software device performance study:

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

Not applicable/Not provided for a performance study. This submission relies on equivalence to an existing device, not a new clinical performance trial.

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

Not applicable/Not provided. Ground truth establishment for a test set is specific to performance studies, especially for diagnostic or analytical devices.

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

Not applicable/Not provided. This refers to methods for resolving discrepancies in expert opinions on a test set, which is not relevant here.

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 is highly specific to AI-assisted diagnostic or interpretation devices and does not apply to a physical orthodontic bracket.

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

Not applicable/Not provided. This refers to AI algorithm performance in isolation, not a physical medical device.

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

Not applicable/Not provided. Ground truth definition is for performance studies, not for demonstrating substantial equivalence of a physical device.

8. The sample size for the training set:

Not applicable/Not provided. Training sets are for machine learning algorithms, not for the regulatory submission of a physical medical device.

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

Not applicable/Not provided. As above, related to machine learning, not this type of device submission.

In summary, the provided text is a 510(k) premarket notification for an orthodontic bracket, which primarily demonstrates substantial equivalence to a predicate device. It does not contain the detailed performance study information (acceptance criteria, sample sizes, ground truth establishment, MRMC studies) typically found for AI/software-as-a-medical-device (SaMD) or novel diagnostic device submissions.

Summary

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Image /page/0/Picture/18 description: The image shows the Sybron Dental Specialties logo with the text "SYBRON DENTAL SPECIALTIES" below it. Above the logo, the date "NOV 3 0 2005" is printed. To the left of the logo, the text "K 052477" is written in handwriting.

Section 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

Date Summary Prepared: September 2005

Device Name:

Trade Name Damon 3 Modified .
Common Name Plastic Orthodontic Bracket .
Classification Name Bracket, Plastic, Orthodontic, per 21 CFR § 872.5470 .

Devices for Which Substantial Equivalence is Claimed:

Ormco Corporation, Damon 3 ●

Device Description:

Intended Use of the Device:

The intended use of Damon 3 Modified is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

Substantial Equivalence:

Damon 3 Modified is substantially equivalent to other legally marketed devices in the Damon 3 Modified functions in a manner identical to and is intended for the same use as the original Damon 3 bracket that is currently manufactured 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 perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, with flowing lines beneath them that could represent water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

Ormco Corporation C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K052477

Trade/Device Name: Damon 3 Modified Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: September 8, 2005 Received: September 12, 2005

Dear Ms. 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 / Intenditer, of to are, 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 approvisions of the Act. The general controls provisions of the Act include controls providents of an 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 (1 Writ), it may be sacross 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. 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 moun that 221 mm made statutes and regulations administered by other Federal agencies. or the Fet of any 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 and instills (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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 premainverlent 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), 11 you dents the Office of Compliance at (240) 276-0115. 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 may overn 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/industry/support/index.html.

Sincerely yours,

Clive St. Rom

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

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K052477

Indications for Use

510(k) Number (if known):

Device Name: Damon 3 Modified

Indications For Use:

Damon 3 Modified is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

antinana

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

THE RESEART PLACES OF CALLERS OF CALLERS OF A

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Parmer
	Division of Anesthesiology, General Hospital,
	Infection Control, Dental Devices
510(k) Number:	K052477

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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.