The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.

Device Description

The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.

AI/ML Overview

This submission is a 510(k) premarket notification for a Class II medical device, the Keles Facemask, an orthodontic headgear. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. Therefore, there are no specific "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy) for an AI model or a new diagnostic technology.

Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in design, materials, manufacturing, and intended use to a predicate device. The "study" that proves the device meets these criteria is the submission itself, which provides a detailed comparison to the predicate device.

Here's an analysis based on the provided document:

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

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated in submission)
Intended Use: Device is intended for the same use as the predicate.	The Keles Facemask is intended for the treatment of patients with Class III malocclusions, especially useful in patients with an anterior bite tendency or condition. This matches the implied intended use of similar orthodontic extraoral headgear.
Technological Characteristics: Device has similar technological characteristics to the predicate.	"The Keles Facemask and predicate consists of similar extraoral and intraoral components." All components have been used in legally marketed devices or have been found to be safe for dental use.
Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness.	The submission concludes: "We conclude that the similarity in design between the Keles Facemask and the predicate device supports the safety and effectiveness of the Keles Facemask for the indicated uses." The FDA's clearance letter confirms their agreement with this conclusion.

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

Not applicable. This submission is for a physical medical device (orthodontic headgear), not a data-driven device like an AI algorithm. Therefore, there is no "test set" of patient data in the context of an AI study. The determination of substantial equivalence relies on a comparison of device characteristics, materials, and intended use.

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

Not applicable. See point 2. The "ground truth" here is established by regulatory standards and expert opinion within Great Lakes Orthodontics regarding the safety and effectiveness of their design compared to a known safe and effective predicate device.

4. Adjudication method for the test set

Not applicable. See point 2. The regulatory review process itself involves expert review by the FDA, who adjudicates the submitted evidence for substantial equivalence.

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 device is a physical orthodontic device, not an AI diagnostic tool.

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

Not applicable. This device is a physical orthodontic device, not an AI algorithm.

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

The "ground truth" for this type of submission is the established safety and effectiveness of the legally marketed predicate device. The manufacturer asserts, and the FDA concurs, that the Keles Facemask is substantially equivalent to this predicate, implying it meets the same safety and effectiveness standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable. See point 8.

Summary

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K04/7/8

OCT 5 2004

Image /page/0/Picture/2 description: The image is a logo for Great Lakes Orthodontics. The logo features a black and white image of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a semi-circle above the image, and the word "ORTHODONTICS" is written in a semi-circle below the image. There are two dots on either side of the image.

Great Lakes Orthodontics, LTD.

An Employee Owned Company

Our Vision "Delight our customers. Respect and help our co-workers."

510(k) SUMMARY

CONTACT PERSON: Mr. David Graver Great Lakes Orthodontics 800-828-7626 dgraver@greatlakesortho.com

DATE PREPARED: June 23, 2004

TRADE OR PROPRIETARY NAME: Keles facemask COMMON NAME: Protraction Facemask CLASSIFICATION NAME: Orthodontic Extraoral Headgear 872.5500 PRODUCT CODE: DZB

PREDICATE DEVICE: Nitom Facebow Ortho Kinetics 1611A South Melrose Dr. Vista, CA 92083

DEVICE DESCRIPTION

The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.

INTENDED USE The Keles Facemask is intended for the treatment of patients with Class III malocclusions

TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE The Keles Facemask and predicate consists of similar extraoral and intraoral components.

We conclude that the similarity in design between the Keles Facemask and the predicate device supports the safety and effectiveness of the Keles Facemask for the indicated uses.

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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three horizontal lines curving upwards, with a wavy line underneath them.

OCT 15 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Graver Manager Great Lakes Orthodontics, Limited 200 Cooper Avenue P.O. Box 5111 Tonawanda, New York 14151-5111

Re: K041718

Trade/Device Name: Keles Facemask Regulation Number: 872.5500 Regulation Name: Extraoral Orthodontic Head Regulatory Class: II Product Code: DZB Dated: June 23, 2004 Received: July 19, 2004

Dear Mr. Graver:

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 (1 Nr.), it ind) 0 of 520 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Graver

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. or the 100 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 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 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 yours,

Susan Cunn

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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Keles Facemask

Indications for Use

510(k) Number (if known): K041716

Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150

Device Name: Keles Facemask

Indications for Use:

Prescription Use v

AND/OR

Over-The-Counter Use

(21 CFR Part 801 Subpart D)

(21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rupp

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Of Anesthesiology, General Devices Division of Ancolnoon Dental Devices

Page 1 of 1_ 510(k) Number:

Regulation Number and Section

§ 872.5500 Extraoral orthodontic headgear.

(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.