ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Device Description

Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.

AI/ML Overview

The provided regulatory submission describes a 510(k) premarket notification for the ARGEN PMMA device, a polymethylmethacrylate (PMMA) disc for dental CAD/CAM systems. The submission asserts substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the information required to directly answer some of the questions (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods) is not explicitly detailed in the provided documents. The approach taken is a comparison of material properties to demonstrate equivalence.

Here's a breakdown based on the available information:

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

Since this is a substantial equivalence submission, "acceptance criteria" are implied by demonstrating that the ARGEN PMMA device has comparable physical and chemical properties and biological performance to its predicate devices. The reported "performance" is that these properties are similar or identical.

Property / Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ARGEN PMMA)
Composition	Polymethylmethacrylate (PMMA) hot cured polymer	Polymethylmethacrylate (PMMA) hot cured polymer
Indications for Use	Used to mill long-term temporary substructures for crowns & bridgework in CAD/CAM systems	Used to mill long-term temporary substructures for crowns & bridgework in CAD/CAM systems
Physical Properties	Similar e-modulus, flexural strength, and deflection to predicates	Comparable e-modulus, flexural strength, and deflection to predicates
Chemical Properties	Similar to predicates	Similar to predicates
Polymerization Grade	High	High
Aesthetic Function	Same as predicates	Same as predicates
Biological Performance	Non-toxic, same as substantially equivalent Dental Acrylic teeth	Non-toxic, same as substantially equivalent Dental Acrylic teeth

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The submission relies on comparative data and general material properties rather than a specific test set for performance validation in the typical sense of a diagnostic or therapeutic device study.
Data Provenance: Not explicitly stated. The tests conducted (ASTM F895-84:1984, ISO 10993.5:1999, US Pharmacopeia XXVIII) are international standards, suggesting data would be generated according to these protocols, but the specific origins are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. The submission is not a clinical study involving expert interpretation of results, but rather a materials science comparison.

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

Not applicable/Not mentioned. No expert adjudication process is described for this type of submission.

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 dental material (PMMA discs), not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is a dental material, not an algorithm.

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

The "ground truth" for this submission is based on established material science standards and properties of the predicate devices. The claim is that ARGEN PMMA meets these established material characteristics. For biological performance, it refers to the non-toxic nature of PMMAresin, which is a widely accepted characteristic in dentistry.

8. The sample size for the training set

Not applicable. This type of submission does not involve a "training set" in the context of machine learning or statistical modeling.

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

Not applicable, as there is no "training set" in this context.

Summary

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JUL 3 1 2014

Alloy Makers To The World

Image /page/0/Picture/3 description: The image shows the logo and contact information for The Argen Corporation. The logo features a stylized letter "A" in bold, black font, with the word "ARGEN" appearing to the right of the "A". Below the logo, the text provides the company's address as 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The telephone number is (858) 455-7900, and the fax number is (858) 626-8686.

510(k) Summary

Submitted by:

The Argen Corporation 5855 Oberlin Drive, San Diego, CA 92121 (858) 455-7900 x471 (PHONE), (858) 626-8686 (FAX)

Contact person: Craig Jolicoeur

Date prepared: 4/02/2013

Trade name: ARGEN PMMA Common name: PMMA Resin Classification name: Temporary Crown and Bridge Material (21 CFR 872.3770 Product Codes EBG, ELM)

Legally marketed devices for which our organization is claiming substantial equivalence:

510(k)Number	Trade Name	Manufacturer
K102341	VIPI Block	VIPI INDUSTRIA, COMERCIO,EXPORTACAO EIMPORTACAO DE
K071548	WIELAND ZENO CAO TEMPORARYPMMA DISC, TOOTH-COLORED	MERZ DENTAL GMBH
K061809	EGRAL IMCROWN	MERZ DENTAL GMBH
K060293	TEMPORARY CROWN AND BRIDGEMATERIAL	DENTSPLY INTERNATIONAL.INC.

Device Description: Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.

Intended Use: ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.

Predicate devices: K071548, K061809, K060293.

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Summary of the physical testing conducted on the device:

ARGEN PMMA discs are substantially equivalent and/or identical ' to the dental devices listed above.

The proposed and predicate devices are both composed of polymethylmethacrylate. A hot cured polymer, and have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. The polymerization grade of both devices is high. In addition, they have the same aesthetic function.

We can conclude that ARGEN PMMA discs have comparable technological characteristics to the predicate device.

Summary of the biological testing conducted on the device:

Although this device comes into direct contact with the patient, the material is considered to be non-toxic. The material was tested in accordance with ASTM F895-84:1984. ISO 10993.5:1999 and US Pharmacopeia XXVIII.

PMMA resin continues to be the universal versatile polymer in denture dentistry.

The Acrylic PMMA block has the same biological performance as substantially equivalent Dental Acrylic teeth.

Substantial equivalence:

The proposed and predicate devices are composed of a polymethyl metacrylate hot cured polymer. All devices have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. All devices have comparable e-modulus, flexural strength and deflection. The polymerization grade of both devices is high. And they have the same aesthetic function.

Conclusion:

We are claiming substantial equivalence of the ARGEN PMMA disc to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, representing the department's mission of protecting the health of all Americans.

Public Health Service

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

July 31, 2014

The Argen Corporation Mr. Craig Jolicoeur Quality & Regulatory Manager 5855 Oberlin Drive San Diego, CA 92121-4718

Re: K140894

Trade/Device Name: ARGEN PMMA Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 2, 2014 Received: May 5, 2014

Dear Mr. Jolicoeur:

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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Page 2 - Mr. Jolicoeur

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 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 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/Resourcesfor You/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Division 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/4/Picture/0 description: The image shows the logo for The Argen Corporation, a company that makes alloys. The logo features a stylized letter 'A' with the company name written across it. The company's address is 5855 Oberlin Drive, San Diego, CA 92121-4718, United States of America. The phone number is (858) 455-7900, and the fax number is (858) 626-8585.

Indications for Use Statement

510(k) Number (if known):

Device Name: ARGEN PMMA

Indications For Use:

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use _ · (21 CFR 807 Subpart C)

Sheena A. Green -S 2014.07.31 07:45:38 -04'00'

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.