Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

Device Description

Esthetica is a durable, composite resin-based mill block for chairside and laboratory milling applications. Esthetica is milled as a restoration that is subsequently cemented in place. Esthetica is a highly esthetic, single material, next generation composite block that can be used as an alternative to Porcelain and Porcelain/Zirconia blocks. Esthetica offers Biomimetic features that will wear, age, look, feel, and function like a natural tooth.

AI/ML Overview

The provided text describes the regulatory clearance of a dental material called "Esthetica," a composite resin-based mill block. It is a 510(k) submission, meaning it claims substantial equivalence to a predicate device, not necessarily a new device with novel performance characteristics that require extensive clinical studies with specific acceptance criteria as you've outlined.

Therefore, the document does not contain the kind of information typically found in studies for AI/software-as-a-medical-device (SaMD) or other diagnostic devices. It does not describe:

Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
A "study that proves the device meets the acceptance criteria" in terms of clinical diagnostic performance.
Sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic algorithm.

Instead, the provided text focuses on the material characteristics and biocompatibility of the dental block. Here's a breakdown of what is available in relation to your request, and where information is missing:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are implicitly that Esthetica's material characteristics are comparable to the predicate device (3M ESPE Adult Crown/Paradigm MZ100 Blocks). The study performed was bench testing and biocompatibility testing.

Table (reconstructed based on the text):

Characteristic Evaluated	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Esthetica)
Flexural Strength	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Compressive Strength	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Diametral Strength	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Flexural Modulus	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Fracture Toughness	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Opacity	Comparable to 3M ESPE Adult Crown	Implied to meet, as found substantially equivalent
Biocompatibility	Safe for intended use	Demonstrated to be safe

Study Proving Device Meets Acceptance Criteria:

The study referenced is "bench testing used to evaluate the performance characteristics of Esthetica compared to the predicate device, 3M ESPE Adult Crown," and a "biocompatibility study." The conclusion is that "the clinical performance of Esthetica is substantially equivalent to restorations produced using the predicate device" based on these tests.

Missing Information (as per your request, because this is not a diagnostic device study):

Sample size used for the test set and the data provenance: Not applicable. This was material testing, not a diagnostic test on a human population. The sample size would refer to the number of material specimens tested, which is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert readers to establish ground truth for diagnostic imaging or patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a dental material, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for material characteristics would be the established scientific methods for measuring those properties (e.g., ASTM standards for mechanical properties). For biocompatibility, it would be in vitro or in vivo toxicity testing, with acceptance criteria defined by relevant standards (e.g., ISO 10993). The specific standards or methodologies are not detailed in this summary.
The sample size for the training set: Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a dental material, not a document describing a clinical study or performance evaluation of an AI-driven diagnostic device. Therefore, most of the specific questions about acceptance criteria, study design, and ground truth for a diagnostic device are not relevant to this content.

Summary

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Section III - 510(k) Summary of Safety and Effectiveness

MAR 1 9 2010

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: March 2010

Device Name:

. Trade Name - Esthetica
. Common Name - Composite Resin-Based Block
Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

Devices for Which Substantial Equivalence is Claimed:

3M Company, 3M ESPE Adult Crown .

Device Description:

Intended Use of the Device:

Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

Substantial Equivalence:

Esthetica is substantially equivalent to other legally marketed devices in the United States. Esthetica functions in a manner similar to and is intended for the same use as 3M ESPE Adult Crown that is currently marketed as Paradigm MZ100 Blocks for CEREC by 3M Company. A biocompatibility study was completed, which demonstrates that the material is safe for its intended use.

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This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of Esthetica compared to the predicate device, 3M ESPE Adult Crown. The characteristics evaluated include Flexural Strength, Compressive Strength, Diametral Strength, Flexural Modulus, Fracture Toughness and Opacity.

Based upon the biocompatibility test and the bench testing, the clinical performance of Esthetica is substantially equivalent to restorations produced using the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

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

MAR 1 9 2010

Kerr Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K100083

Trade/Device Name: Esthetica Regulation Number: 21 CFR 872.3690 -Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBG Dated: January 8, 2010 Received: January 12, 2010

Dear Ms. Garman:

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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100083

Indications for Use

510(k) Number (if known):

Device Name: Esthetica

Indications For Use:

Esthetica is a composite resin-based block intended for the preparation of inlays, onlays, veneers, full crowns, bridges and crowns for implant restorations.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DNS for Dr. K.P. Murley
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

< 100083 510(k) Number: Page 1 of 1

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.