This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.

AI/ML Overview

The provided text describes a 510(k) submission for the "Quantum LB" orthodontic adhesive. The study aims to demonstrate substantial equivalence to a predicate device, Transbond XT.

Here's an analysis of the acceptance criteria and the study presented:

Quantum LB Orthodontic Adhesive - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Quantum LB device, as per the provided summary, is similar performance to the predicate device (Transbond XT) in shear bond strength. No specific numerical thresholds are given for this similarity, but the summary states it was achieved.

Property	Acceptance Criteria (Implied)	Reported Device Performance (Quantum LB)
In-vivo Shear Bond Strength	Similar to Transbond XT	"Testing resulted in similar performance between the two adhesives."
Biocompatibility (Local/Systemic Effects)	No adverse effects	"determined to not directly or through the release of material constituents produce adverse local or systemic effects."
Cytotoxicity (ISO 10993-5 Elution Method)	Grade < 2 (Mild reactivity)	"showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity)."

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

The document states an "in-vivo performance test method for shear bond strength" was used. However, it does not explicitly state the sample size for this test. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

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

This section is not applicable as the study appears to be a laboratory/performance test, not one relying on expert interpretation for ground truth. The "ground truth" here is the measured shear bond strength, which is an objective, quantitative metric.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focuses on direct performance comparison of the device against a predicate, not on the improvement of human readers with AI assistance.

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

This question is not applicable as the device is a physical orthodontic adhesive, not a diagnostic algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the shear bond strength testing is the measured shear bond strength itself, which is an objective, quantitative outcome. For biocompatibility and cytotoxicity, the ground truth is established by the results of standardized biological assays (ISO 10993).

8. The Sample Size for the Training Set

This question is not applicable. The Quantum LB is a physical medical device, not a machine learning algorithm, so there is no "training set."

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

This question is not applicable as there is no training set for this type of device.

In summary, the provided document focuses on demonstrating the performance and safety of a new orthodontic adhesive by comparing it to an already legally marketed predicate device through physical and biological testing. It is a traditional medical device submission and does not involve AI or expert-based diagnostic performance studies.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

October 6, 2016

Reliance Orthodontic Products Inc. Paula Wendland Regulatory Affairs Manager 1540 West Thorndale Ave Itasca, Illinois 60143

Re: K161684

Trade/Device Name: Quantum LB Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin And Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: June 15, 2016 Received: June 17, 2016

Dear Paula Wendland:

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 devicerelated adverse events) (21 CFR 803); 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Susan Runno DDS, MA

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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Image /page/2/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem on the left, containing the letter 'R' in a stylized font. To the right of the emblem is the company name, "Reliance Orthodontic Products, Inc.", written in an elegant, cursive typeface. A thin line underlines the text, adding a touch of sophistication to the overall design.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.

SECTION 6.0 INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): __K161684 __________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

This Device is intended for use as a light cure, orthodontic adhesive.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Image /page/3/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem on the left, containing the letter "R" in a stylized font. To the right of the emblem is the company name, "Reliance Orthodontic Products, Inc.", written in an elegant, cursive typeface with a line underneath.

800-323-4348 · Phone 630-773-4009 · Fax 630-25 x 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 ·

Section 5.0 510 (k) Summary

Note: This summary is provided in accordance with 21CFR807.92(c).

510(k) Owners Name: Reliance Orthodontic Products, Inc. Paul Gange, President/Owner

Address: 1540 West Thorndale Ave. Itasca, IL 60143 USA

Contact Phone Number: 630-773-4009 Fax Number: 630-250-7704

Contact Person: Paula Wendland, Regulatory Affairs Manager

Date 510(k) Summary was Prepared: May 31st, 2016

Medical Device Name:

Trade name Quantum LB .
Common name Orthodontic Bracket Adhesive .
Classification name -- Adhesive, Bracket and Tooth Conditioner, Resin o (21CFR872.3750, Product Code DYH, Class II Device)

LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:

Transbond XT 510(k) K880393 0

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Image /page/4/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem with the letters "R" and "P" intertwined. The company name is written in a cursive font to the right of the emblem. A horizontal line is underneath the company name.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.

5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

5.2 INTENDED USE AND POPULATION:

This device is intended for use as a light cure, orthodontic adhesive.

5.3 PREDICATE DEVICE:

3M Unitek Transbond XT, 510(k) submission (K880393) dated 3/31/1998 is similar in intended use, handling and technology compared to the device described in this submission.

Property	QUANTUM LB	TRANSBOND XT
Intended Use	Light Cure OrthodonticAdhesive	Light Cure OrthodonticAdhesive

5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS.

Intended Use	Light Cure Orthodontic Adhesive	Light Cure Orthodontic Adhesive
Composition	Methacrylate Monomer	Methacrylate Monomer
Product Features	Bonds to conditioned Enamel, Composite, Porcelain and Metal tooth surfaces.	Bonds to conditioned Enamel, Porcelain and Metal tooth surfaces.
Dispensing Method	Push Syringe and Tips	Push Syringe and Tips
Method of Cure	Light Cure	Light Cure

5.5 Summary:

The Quantum LB was tested against Transbond™ XT using in-vivo performance test method for shear bond strength. Testing resulted in similar performance between the two adhesives.

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Image /page/5/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a circular emblem with the letter "R" inside, followed by the company name written in a cursive font. The words "Reliance Orthodontic Products, Inc." are underlined with a thin line. The overall design is simple and elegant, conveying a sense of professionalism and quality.

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 P.O. Box 678, 1540 West Thorndale Ave. Itasca, IL · 60143 ·

A biocompatibility evaluation was conducted per ISO10993 for the composition of the Quantum LB device and determined to not directly or through the release of material constituents produce adverse local or systemic effects.

In addition, Cytotoxicity testing was conducted on Quantum LB using the ISO 10993-5 Elution Method. The Quantum LB was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test following the guidelines of ISO10993-5, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity. The Quantum LB showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity).

Audume 10.6.16

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.