DUCERAGOLD® PORCELAINS are dental ceramic veneering preparation of crowns and bridges.
DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.

AI/ML Overview

The provided text is a 510(k) summary for the DUCERAGOLD® PORCELAINS, a dental ceramic veneering material. This document is a regulatory submission for premarket notification to the FDA, asserting substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.

Here's why and what information is available:

Device Type: This is a material (porcelain powders for dental use), not an AI-powered diagnostic device or a system that produces a performance metric like sensitivity or specificity. Its safety and effectiveness are typically demonstrated through material properties, biocompatibility, and comparison to existing, legally marketed materials.
Regulatory Pathway: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. This often involves showing similar technological characteristics and comparable performance, rather than conducting new, large-scale clinical trials that would generate acceptance criteria and performance data in the typical sense of measuring algorithm accuracy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable or not present in this type of regulatory document for this specific device.

However, I can extract the relevant information that is present:

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

Acceptance Criteria	Reported Device Performance
Technological Characteristics: Similar to legally marketed predicate devices.	DUCERAGOLD® PORCELAINS have been used in legally marketed devices. The formulations are very similar to legally marketed predicate devices and have not changed in any way that would adversely affect biocompatibility.
Safety and Effectiveness: Supported by prior use of components, similarity in formulations to marketed devices, and performance data.	The document states: "We believe that the prior use of the components in legally marketed devices, the similarity in the formulations that the prior any marketed devices, and the performance data provided support the safety and effectiveness of DUCERAGOLD® PORCELAINS for the intended use."

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

Not Applicable / Not Provided: This document describes a material and its substantial equivalence to predicate devices, not a study involving a "test set" of patient data or algorithm performance. The "performance data provided" is not detailed in this summary.

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 Provided: No expert consensus or ground truth establishment of this nature is described, as it's not a diagnostic device.

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

Not Applicable / Not Provided: No adjudication method is described.

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 / Not Provided: This is not an AI-powered device, and no MRMC study is mentioned.

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

Not Applicable / Not Provided: This is not an algorithm, so standalone performance is not relevant.

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

Not Applicable / Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this type of device is typically established through material science testing (e.g., strength, durability, biocompatibility) and clinical experience with similar materials. The document implies that the safety and effectiveness are supported by the known performance of its components and similar formulations in legally marketed devices.

8. The sample size for the training set

Not Applicable / Not Provided: This is not an AI algorithm, so there is no training set.

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

Not Applicable / Not Provided: As there is no training set, this question is not applicable.

Summary

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510(k) SUMMARY

K04042|

NAME & ADDRESS:

MAR 1 8 2004

DENTSPLY International

World Headquarters Susquenanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 717| 845-7511 (voice) 1767 www.dentsply.com

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

February 17, 2004 DATE PREPARED:

DUCERAGOLD® PORCELAINS TRADE OR PROPRIETARY NAME:

Porcelain powders for clinical use (872.6660) CLASSIFICATION NAME:

K931808 Duccragold PREDICATE DEVICES:

DEVICE DESCRIPTION: DUCERAGOLD® PORCELAINS are dental ceramic veneering DE VICE DESCRIPTION. preparation of crowns and bridges.

DUCERAGOLD® PORCELAINS include Dentine, Incisal, Transparent, Correction, Powder Opaque, Redox Opaque, Glaze, Shoulder, Paste Opaque, and Bonder porcelains.

INTENDED USE: Preparation of crowns and bridges - veneering metal framework and copings, and veneering pressable ceramic.

TECHNOLOGICAL CHARACTERISTICS: found רן ו DUCERAGOLD® PORCELAINS have been used in legally marketed devices.

The formulations of DUCERAGOLD® PORCELAINS are very similar to the legally marketed The Nimalatons of D Changed in any way that would adversely affect biocompatibility. Therefore, it was determined that no additional biocompatibility testing was necessary.

We believe that the prior use of the components in legally marketed devices, the similarity in the formulations that the prior any marketed devices, and the performance data provided support the safety and effectiveness of DUCERAGOI.D® PORCELAINS for the intended use.

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is an eagle with three lines extending from its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2004

Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street York, Pennsylvania 17405-0872

Re: K040421

Trade/Device Name: DUCERAGOLD® PORCELAINS Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 17, 2004 Received: February 18, 2004

Dear Mr. Lehn:

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 mersule commerce prices 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, thereforc, market the device, subject to the general approvisions 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 (1 Writ), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.

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Page 2 -Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements mean that I DA mas made a december and regulations administered by other Federal agencies. of the Act of any I ederal bates and systements, including, but not limited to: registration r ou must comply with art 807); labeling (21 CFR Part 801); good manufacturing practice alla fisting (21 CFR Parvov), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ajon 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) Fins letter will anow yource of substantial equivalence of your device to a premiarked predicated. - The PDF 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), If you desire speoffice of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral information on your responsibilities under the Act from the may outant outer generational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runnos

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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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K040421

DUCERAGOLD® PORCELAINS Device Name:

Indications for Use:

Preparation of Crowns and Bridges:

Vencering metal framcwork and copings .
Veneering pressable ceramic .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Usc (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)

Kari Murby for WSR

esthesiology, General Hospital, Control. Dental De

510(k) Number:_**_

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.