ARTEGRAL IMCROWN by MERZ DENTAL GMBH

The provided document is a 510(k) premarket notification for a dental device, "artegra® ImCrown," which is a preformed temporary crown. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific training set details) are not applicable or not explicitly stated in this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics for the device. Instead, the "device performance" is primarily demonstrated by compliance with established international standards and a statement of intended use, implying that if it meets these standards, it is suitable for its intended purpose.

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance to ISO 3336	Tested for compliance
Compliance to ISO 10993	Tested for compliance
Suitable for intended use as provisional anterior crown when fitted with CEREC 3D and inLab Systems	artegral® ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab Systems
Substantial equivalence to predicate devices (Temporary Crown and Bridge Resin)	Found substantially equivalent by FDA

Explanation:

ISO 3336: Specifies requirements for dental polymeric materials for crowns and bridges. Compliance implies the material properties (e.g., strength, durability, biocompatibility) meet a recognized standard. Without the full test report, specific acceptance values (e.g., flexural strength > X MPa) are not provided in this summary.
ISO 10993: Covers biological evaluation of medical devices. Compliance implies the device materials are biocompatible and do not pose unacceptable biological risks. Again, specific acceptance criteria (e.g., no cytotoxicity detected in X assay) are not detailed here.
Intended Use Statement: Demonstrating that the device can fulfill its intended purpose, which is to function as a provisional anterior crown when used with specified systems. The FDA clearance confirms its suitability for this indication.
Substantial Equivalence: This is the primary "performance metric" for a 510(k). The device performs "as well as" or "similarly to" a legally marketed predicate device.

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

Sample Size for Test Set: Not specified in the provided summary. Testing for ISO standards often involves a specific number of samples for each test (e.g., mechanical testing, biocompatibility). However, the exact numbers used for this device are not disclosed here.
Data Provenance: Not explicitly stated (e.g., retrospective/prospective). The testing would have been conducted by the manufacturer (Merz Dental GmbH) in Germany, or by a certified testing laboratory. It would be considered prospective testing for the purpose of demonstrating compliance.

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

Not Applicable. For a device like a temporary crown, "ground truth" isn't established by expert consensus in the same way it would be for an AI diagnostic algorithm. Performance is typically assessed against physical and chemical specifications defined by the ISO standards and the material's intended function. The "experts" would be the engineers and scientists conducting the laboratory tests according to standard protocols.

4. Adjudication method for the test set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic accuracy studies. This is not relevant for the type of laboratory and biocompatibility testing described for this dental device.

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 physical dental product (a preformed crown), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not Applicable. As this is a physical device and not an algorithm, standalone performance (in the context of AI) is not relevant. The "standalone" performance here would refer to the device's material properties and fit, which are covered by the ISO testing.

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

The "ground truth" for this device's performance would be compliance with the specifications outlined in ISO 3336 and ISO 10993 (e.g., specific thresholds for mechanical properties, absence of cytotoxic effects). These standards define acceptable performance based on scientific and clinical understanding of dental materials.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is manufactured based on established material science and engineering principles.

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

Not Applicable. See point 8.

Summary

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K061809

Premarket Notification Preformed Crown

artegral® ImCrown Merz Dental GmbH

VIII. Premarket Notification 510(k) Summary

Submitted by:	Merz Dental GmbHEetzweg 20D-24321 LutjenburgGermany0 43 81/4 03-4 11 (phone)0 43 81/4 09-1 07 (fax)
Contact person:	Dr. Med Claudia Bobrowski
Date prepared:	June 23, 2006
Device proprietary name:	artegral® ImCrown
Common name:	Temporary Crown and Bridge Resin
Classification name:	Temporary Crown and Bridge Resin(21 CFR 872.3770)
Predicate devices:	Temporary Crown and Bridge Resin
Description of the device:	Various shapes and sizes of preformed anteriorcrowns composed of IPN-PMMA with anattachment device for use in the CEREC 3D andinLab Systems.
Intended use:	artegra® ImCrown is indicated for use as aprovisional anterior crown when fitted with theCEREC 3D and inLab Systems
Characteristics:	A preformed anterior crown suitable for anteriorprovisional restorations.
Testing:	Tested for compliance to ISO 3336 and ISO 10993.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2006

Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 4235 Providence Lane Tucker, Georgia 30084

Re: K061809

Trade/Device Name: Artegral ImCrown Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: June 23, 2006 Received: June 27, 2006

Dear Mr. Hunter:

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 - Mr. Hunter

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 (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.

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 vour 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris Liu, Ph.D.

Chiu Lin, Ph.D. 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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Premarket Notification Preformed Crown

artegral ImCrown Merz Dental GmbH

V. Indications for Use Statement K0611809

510(k) Number:

To be assigned

Device Name:

artegral ImCrown

Indications for Use:

artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.

Prescription Use X (Part 21 CFR 801 Sūbpart D)

AND/C)R

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart ) ________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-

Concurrence of CDRH, Office of Device Evaluation (ODE)

Surer Rumer

v. General Hospital.

K061809

Page 10 of 44

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.