Simidur S1S is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.

Device Description

Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work. Simidur S1S is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S1S can be veneered with suitable dental ceramics and with dental composites.

AI/ML Overview

The provided text describes a submission for a dental alloy, Simidur S1S, to the FDA for 510(k) premarket notification. The document states that the device "fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not contain the detailed methodology and results of a study as typically required to demonstrate that a medical device meets specific acceptance criteria in the manner requested. Specifically, it lacks information regarding clinical studies, performance metrics, sample sizes, ground truth establishment, or expert involvement in a medical device testing context.

Thus, I cannot provide the requested table or describe a study in the detailed format requested based on the given information. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device (Argelite 58P, K891320), rather than on a new clinical performance study.

Here's what can be extracted, aligning with the spirit of the request but acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Physical Properties	Compliance with ISO 9693 for dental alloys.	Simidur S1S "fully complies to the international standard ISO 9693".
Biocompatibility	Excellent biocompatibility.	Simidur S1S has "excellent biocompatibility".
Corrosion Resistance	High corrosion resistance.	Simidur S1S is "highly corrosion resistant".
Material Composition	Palladium-base ceramic alloy (56.0% Palladium), copper-free.	Simidur S1S is a "palladium-base ceramic alloy (56,0% Palladium)" and is "free of copper".
Veneering Capability	Suitable for veneering with dental ceramics and composites.	Simidur S1S "can be veneered with suitable dental ceramics and with dental composites."
Indications for Use	Fabrication of dental restorations including crowns, short span bridges, long span bridges, removable partials, and for telescopic and milling work.	Simidur S1S has an "indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work."
Regulatory Compliance	Fulfillment of European directive 93/42/ECC concerning medical devices.	Simidur S1S "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."

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

This information is not provided in the document. The submission relies on "substantial equivalence" to a predicate device and compliance with standards, rather than a clinical trial with a defined test set.

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

This information is not provided. The document does not describe a clinical study or expert-adjudicated test set.

4. Adjudication method for the test set:

This information is not provided. No adjudication method is mentioned as there isn't a described test set requiring one.

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:

No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices, which is not what Simidur S1S is.

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

No, a standalone algorithm performance study was not conducted or described. This device is a physical dental alloy, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by compliance with international standards (ISO 9693) and European directives (93/42/ECC), as well as by demonstration of substantial equivalence to an already marketed device (Argelite 58P). The document does not specify a clinical "ground truth" derived from patient outcomes or pathology in the context of a new study for this submission.

8. The sample size for the training set:

This information is not applicable as Simidur S1S is a material, not an AI model, and therefore does not have a "training set."

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

This information is not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) summary is for a dental material (alloy) and discusses its compliance with established material standards and equivalence to a predicate device, rather than presenting a performance study with detailed clinical acceptance criteria, test sets, or expert evaluations typically associated with diagnostic or AI-driven medical devices.

Summary

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MAR 1 5 2002

K020198

Premarket Notification 510(k)

Simidur S1S

5. 510 (k) Summary

Submitter of 510(k):

Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0

Contact person: Phone: Fax: e-mail:

Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de

Date of Summary:

Trade name:

Simidur S1S

2001-12-14

Classification name: Product code: C.D.R section: Classification:

Alloy, precious metal, for clinical use ETS 872.3060 Class II

Legally marketed Argelite 58P equivalent device: 510(k) number: K 891320

Device description

Simidur S1S is a palladium-base ceramic alloy (56,0% Palladium), intended for dental technicians to fabricate dental restorations.

It has an indication which ranges from single crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and suitable for telescopic and milling work.

Simidur S1S is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

Simidur S1S can be veneered with suitable dental ceramics and with dental composites.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 an emblem featuring a stylized bird-like figure with three wing-like shapes, representing the department's mission related to health and human well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 75120 Pforzheim, GERMANY

Re: K020195

Trade/Device Name: Simidur S1S Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: Class II Product Code: EJS Dated: January 18, 2002 Received: January 22, 2002

Dear Dr. Polzer:

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 - Dr. Gerhard Polzer

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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). Other general information on your 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,

[signature]

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_

Simidur S1S Device Name:

Indications For Use:

Simidur S1S is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.

K020195

It is intended for manufacturing

Crowns ●
Short span bridges .
Long span bridges
Removable partials .

and can be used for

Telescopic and milling work ●
Simidur S1S can be veneered with suitable dental ceramics as well as with dentalcomposites.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K020195

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use........

(Optional Formal 1-2-96)

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.