The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials. The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.

Device Description

The Vitique System consists of: Vitique Cement a highly aesthetic luting cement in various shades; Try-In Pastes that precisely match the corresponding cement shade to approximate the final result: Silanating agent for use in preparing ceramic surfaces for bonding; and Contax Bonding System a bonding system (etching gel, bonding system) for final bonding to tooth structure.

AI/ML Overview

The provided documents are a 510(k) summary and FDA clearance letter for a dental luting material called the Vitique System. This type of submission is for a medical device (dental cement) and does not involve AI or algorithms that would have performance acceptance criteria in the way typically associated with AI/ML diagnostic devices.

Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-specific performance metrics (like MRMC studies) is not applicable to this submission.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the submission is an "Abbreviated 510(k)" and demonstrates conformity with "FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998" and "ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials."

This means the acceptance criteria are based on the standards outlined in ISO 4049 and the general safety and effectiveness requirements for dental cements as per FDA guidance. The submission claims conformity, but specific quantitative acceptance criteria and detailed reported performance values are not provided in the summary. For example, ISO 4049 would specify requirements for properties like:

Acceptance Criteria (Examples based on ISO 4049 for luting materials)**	Reported Device Performance (Not explicitly detailed in summary)
Flexural Strength: > 50 MPa (e.g.)	Conforms to ISO 4049
Water Sorption: < 40 µg/mm³ (e.g.)	Conforms to ISO 4049
Solubility: < 7.5 µg/mm³ (e.g.)	Conforms to ISO 4049
Film Thickness: < 25 µm (e.g.)	Conforms to ISO 4049
Biocompatibility: Compliant with ISO 10993 (e.g.)	Safe and effective for intended use
Bonding Strength: (Specific values would be tested depending on substrate)	Demonstrated substantial equivalence to predicate devices

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

Sample Size: Not specified. Testing would typically involve a certain number of specimens for each physical and chemical property test required by ISO 4049.
Data Provenance: Not specified. These would be lab-based tests performed according to specific standards, so "country of origin" from a clinical data perspective is not applicable. The studies would be prospective in the sense that they are specifically conducted to test the device's properties.

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. This device is a material, not a diagnostic algorithm. "Ground truth" in this context refers to standardized measurements of physical and chemical properties, not expert consensus on an image or clinical assessment. The "ground truth" is typically defined by the test methods themselves (e.g., a rheometer measures viscosity, a mechanical tester measures flexural strength).

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

Not applicable. See point 3. Testing of material properties does not involve adjudication by experts.

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 cement, not an AI/ML diagnostic software. There are no "human readers" or "AI assistance" involved in its core function.

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

Not applicable. This is not an algorithm.

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

Material Property Standards/Measurements. The "ground truth" for a dental cement relies on established physical and chemical measurement techniques and the specifications outlined in relevant ISO standards (e.g., ISO 4049) and FDA guidance documents. For instance, the "ground truth" for flexural strength is the value measured by a calibrated universal testing machine.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no training set.

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

Not applicable. See point 8.

Summary

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K023649

C MG USA Inc. A bbreviated 510(k) Premarket Notification

510(k) Summary

Trade Name:	Vitique System		JAN 17 2003
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901Registration # not yet assigned
Device Generic Name:	Dental luting material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

?redicate Devices:

Product Name	510(k) #	Manufacturer
Variolink II	K971372	Vivadent
Nexus	K972858	Kerr
Panavia F	Unknown	Kuraray
Calibra	Unknown	Dentsply
Rely X	K022476	3M
Vitremer	K933139	3M
Principle	Unknown	Dentsply
ProTec Cem	K980922	Vivadent

Product Description:

The Vitique System consists of:

Vitique Cement a highly aesthetic luting cement in various shades; .
Try-In Pastes that precisely match the corresponding cement shade to approximate the final . result:
Silanating agent for use in preparing ceramic surfaces for bonding; and ●
Contax Bonding System a bonding system (etching gel, bonding system) for final bonding to ● tooth structure.

Indications for Use:

Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG USA, Inc. has provided information to demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.

Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the Vitique System materials have been shown to be safe and effective for their intended use.

200058

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, but it is also designed to incorporate human profiles. The symbol is composed of three stylized profiles facing to the right, with flowing lines that suggest movement or flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

DMG USA, Incorporated C/O Ms. Pamela Papineau Delphi Medical Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K023649 Trade/Device Name: Vitique System Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA

Dated: October 18, 2002 Received: October 30, 2002

Dear Ms. Papineau:

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 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 - Ms. Papineau

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski 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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Page of

510(k) Number (if known): K023649

Device Name: _ Vitique System

Indications for Use:

The Vitique System consists of a highly aesthetic luting cement in various shades, Try-In pastes that precisely match the corresponding cement shade to approximate the final result, a silanating agent to prepare ceramic surfaces for bonding, and a bonding system (etching gel, bonding system) for bonding to tooth structure.

The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyquard gel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
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Over-the -Counter Use
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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:
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000008

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.