BioPorta Solder 1020 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.

Device Description

BioPorta Solder 1020 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold and Silver: 98,5%). BioPorta Solder 1020 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as a solder before ceramic firing for ceramic dental alloys with appropriate melting ranges and compositions, especially AGC® Speziallegierung and BioPorta G, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. BioPorta Solder 1020 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental brazing alloy called "BioPorta Solder 1020." It does not contain information about a study proving device performance against acceptance criteria in the context of an AI/ML or diagnostic device. The document is a regulatory submission for a dental material, focusing on its composition, intended use, and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

Specifically, the document does NOT include:

A table of acceptance criteria and reported device performance: This type of information is common for AI/ML or diagnostic devices where performance metrics (e.g., sensitivity, specificity, accuracy) are evaluated against pre-defined thresholds. For a dental alloy, performance is typically assessed against material standards (like ISO 9333 in this case) rather than clinical performance metrics in a study as you describe.
Sample size for test set and data provenance: No test sets or patient data are mentioned as this is a dental material, not a diagnostic or AI device.
Number and qualifications of experts for ground truth: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone performance study: Not applicable.
Type of ground truth used: Not applicable. The "ground truth" for a dental alloy would be its material properties meeting specified standards.
Training set sample size: Not applicable.
How ground truth for training set was established: Not applicable.

Instead, the document states that "BioPorta Solder 1020 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This indicates that compliance with established material standards (ISO 9333 and EC directive) serves as the basis for its safety and effectiveness, rather than a clinical trial or AI performance study.

In summary, the provided text does not contain the information required to answer your query, as it pertains to a different type of medical device (a dental alloy) than what your questions are designed for (AI/ML or diagnostic devices).

Summary

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KO224ba

Premarket Notification 510(k)

BioPorta Solder 1020

5. 510 (k) Summary

SEP 1 8 2002

Submitter of 510(k): Wieland Dental + Technik GmbH & Co. KG Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0

Contact person:	Dr. Gerhard Polzer
Phone:	+49-7231-3705-219
Fax:	+49-7231-357959
e-mail:	gerhard.polzer@wieland-dental.de

Date of Summary: 2002-06-18

Trade name: BIOPORTA SOLDER 1020

Classification name: Alloy, gold based, for clinical use Product code: EJT 872.3060 C.D.R section: Classification: Class II

Legally marketed equivalent device: VS 1 Plus 510(k) number: K 952499

Device description

BioPorta Solder 1020 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges.

It is intended as a solder before ceramic firing for ceramic dental alloys with appropriate melting ranges and compositions, especially AGC® Speziallegierung and BioPorta G, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.

BioPorta Solder 1020 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or a series of interconnected human profiles. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2002

Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY

Re: K022462

Trade/Device Name: BioPorta Solder 1020 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 22, 2002 Received: July 26, 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.

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.

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Page 2 - Dr. Polzer

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 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 legal]y 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,

Timothee A. Utaegbulam

Timothy Ulatowski 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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510(k) Number (if known): K022462
BioPorta Solder 1020

Device Name:

Indications For Use:

BioPorta Solder 1020 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration.

lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.

(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)

Over-The-Counter Use......
(Optional Format 1-2-96)

OR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:

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.