Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).

Device Description

Orthodontic Acrylic is a fast curing self-cure 2-part system. The system consists of a powder and a liquid. The combination of the powder and liquid is converted into a hard methacrylate finished product.

AI/ML Overview

The provided document is a 510(k) premarket notification for an orthodontic acrylic device. It does not contain any information about an AI/ML powered device, a comparative effectiveness study, or details about ground truth establishment with experts. The document focuses on the substantial equivalence of the Orthodontic Acrylic to a predicate device based on chemical composition and physical/mechanical properties.

Therefore, many of the requested sections regarding AI/ML powered devices, expert adjudication, and ground truth establishment cannot be answered from the provided text.

Here's a breakdown of the information that can be extracted, acknowledging the limitations for AI/ML related questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data in terms of physical/mechanical properties and biocompatibility. It does not explicitly state "acceptance criteria" with numerical targets, but rather mentions "meeting the requirements" or providing "similar" results to the predicate.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Physical/Mechanical Properties	Demonstrates similarity to the predicate device per ISO 20795-2:2010.	Tested for flexural strength, flexural modulus, fracture toughness, water sorption, and water solubility. The information provided demonstrates that they are similar to the predicate. (Specific values are not provided in this summary but are referenced as being in the 510(k)).
Biocompatibility	Meets requirements of ISO 7405:2008 and ISO 10993-1.	Orthodontic Acrylic was tested for Guinea Pig Maximization Sensitization Testing and Oral Mucosal Irritation (ISO 10993-10) and cytotoxicity (ISO 10993-5); Orthodontic Acrylic met the requirements for these tests.
In-vitro Testing	Not explicitly stated as acceptance criteria.	In-vitro testing was conducted on Candida albicans, Streptococcus mutans, and Actinomyces naselundii. (Results or specific criteria for these tests are not provided in this summary.)

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

Test Set Sample Size: Not specified. The document refers to "in-vitro testing" and "biocompatibility testing" but does not give sample sizes for these tests.
Data Provenance: Not explicitly stated but implied to be laboratory testing ("tested in the lab") for physical/mechanical properties and in-vitro/in-vivo animal testing for biocompatibility. There is no information regarding country of origin for the data (beyond the applicant being in Illinois, USA) or if it's retrospective or prospective.

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

Not Applicable. This document describes the evaluation of a dental material, not an AI/ML device that would require expert-established ground truth from medical images or clinical data. The "ground truth" for this device comes from standardized chemical, physical, and biological tests.

4. Adjudication method for the test set

Not Applicable. As above, no expert adjudication is mentioned or relevant for this type of device evaluation.

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

No. This document is for a dental material, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

No. This document is for a dental material. There is no algorithm discussed.

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

The "ground truth" for this device's performance is established through objective, standardized laboratory measurements of physical/mechanical properties (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) against established international standards (ISO). For the in-vitro testing, the ground truth would be the observed bacterial/fungal growth or inhibition under controlled lab conditions.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. This is not an AI/ML device, so there is no "training set."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

September 12, 2014

Lang Dental Manufacturing Co., Inc. c/o Michelle Schlitz-Taing Regulatory Affairs Product Registration Manager Bisco. Inc. 1100 West Irving Park Road Schaumburg, IL 60193

Re: K141439

Trade/Device Name: Orthodontic Acrylic Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI Dated: June 24, 2014 Received: June 26, 2014

Dear Ms. Schlitz-Taing:

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.

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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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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50 (k) Number (if known) 6 E F L F T Y

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LANG®

510 (k) SUMMARY

Applicant:	Lang Dental Manufacturing Company Incorporated175 Messner DriveP.O. Box 969Wheeling, Illinois 60090-0969
Contact Person:	Michelle Schiltz-TaingTel: 847-534-6146Fax: 847-534-6146
Date Prepared:	22 May 2014
Trade Name:Common Name:	Orthodontic AcrylicFast Curing Orthodontic Acrylic Resin Powder and Liquid
Product Code:Classification/Name:	EBIDenture relining, repairing, or rebasing resinClass II per 21 CFR 872.3760
Predicate Devices:

Orthodontic Acrylic is substantially equivalent to the following Lang Dental Manufacturing Company Incorporated's:

Ortho-Jet Acrylic Resin - Sparkle (K941925) and Ortho-Jet (a pre-amendment device in continuous distribution since 1969)

Indications for Use:

Orthodontic Acrylic intended for the fabrication of methacrylate-based orthodontic appliances (such as retainers, bite guards, and bite plates, etc.).

Description of Applicant Device:

Technological Characteristics:

Orthodontic Acrylic is based upon industry standard chemistry. The Orthodontic Acrylic Liquid contains Quaternary Ammonium Methacryloxy Silicate (QAMS). In-vitro testing on Candida albicans, Streptococcus mutans and Actinomyces naselundii was conducted. In-vivo clinical studies to evaluate the effect of QAMS in the oral

www.lango

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Image /page/4/Picture/0 description: The image shows the logo for LANG. The logo is in a light gray color, except for the "A" which has a blue arrow going through it. There is a line going through the bottom of the letters.

environment and the prevention of bacteria and fungus-induced stomatitis have not been performed.

Comparisons of the chemical composition of Orthodontic Acrylic to the predicate are provided in the following table:

Chemical Composition	Ortho-Jet Acrylic Resin -SparkleK941925	OrthodonticAcrylic
Auto-Polymerizing	X	X
Methacrylate Resin	X	X
Plasticized poly-methyl methacrylate	X	X
3:1 (Powder: Liquid) ratio	X	X
Quaternary Ammonium MethacryloxySilicate (QAMS)	---	X

Performance Data:

The physical/mechanical properties of Orthodontic Acrylic were tested in the lab using ISO 20795-2:2010 for flexural strength, flexural modulus, fracture toughness, water sorption, and water solubility. The information provided in this 510(k) for Orthodontic Acrylic compared to the predicate demonstrates that they are similar.

In-vitro testing was conducted on Candida albicans, Streptococcus mutans and Actinomyces naselundii.

Biocompatibility:

An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to testing requirements to determine the safety of Orthodontic Acrylic.

Orthodontic Acrylic was tested for Guinea Pig Maximization Sensitization Testing and Oral Mucosal Irritation (150 10993-10) and cytotoxicity (150 10993-5); Orthodonic Acrylic met the requirements for these tests.

Conclusion:

Side by side comparisons demonstrate that the applicant device is substantially equivalent to the predicate legally marketed devices.

www.langde

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.