Porta IP Solder V-2 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. It should be used only together with recommended dental alloys with suitable melting ranges and compositions.

Device Description

Porta IP Solder V-2 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, Platinum, Iridium and Silver: 99,4%). Porta IP Solder V-2 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 solder before firing for dental ceramic alloys with appropriate melting ranges and compositions, especially Porta Geo Ti, Porta SMK 82, Portalloy 54, and Simidur S1S and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta IP Solder V-2 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

This document is a 510(k) premarket notification for a dental brazing alloy called "Porta IP Solder V-2". The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against acceptance criteria through a specific study as you might find for novel clinical diagnostic or therapeutic devices.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not typically present in this type of submission for this class of device.

Here's why and what information is available:

Device Type: Porta IP Solder V-2 is a dental brazing alloy. These are often classified as Class II devices, and their performance is primarily assessed through compliance with recognized standards and comparison to a predicate device.
510(k) Purpose: The 510(k) process demonstrates "substantial equivalence" to a predicate device already on the market. It does not typically require extensive clinical trials or complex performance studies like those for AI/ML-driven diagnostic devices.
Predicate Device: The predicate device is "Argesol 600" (510(k) number: K954360). The submission aims to show that Porta IP Solder V-2 is as safe and effective as Argesol 600.

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this type of device in a 510(k) context is "substantial equivalence" to the predicate device and compliance with relevant standards. The document states: "Porta IP Solder V-2 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."
- Reported Device Performance: The document describes the device's properties (yellow alloy, high precious metal content, suitable for joining dental alloy parts, intended as solder before firing for specific ceramic alloys). It doesn't present quantitative performance data against specific, pre-defined acceptance criteria in the way a diagnostic algorithm might (e.g., sensitivity, specificity thresholds). Instead, the performance is implicitly linked to its composition, intended use, and compliance with standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. Performance studies with test sets in the context you're describing are not detailed for this type of chemical-mechanical dental material in a 510(k) summary.
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):
- This information is not provided and is not relevant for this type of device. "Ground truth" in the context of expert consensus is typically associated with diagnostic or image-based devices, not dental alloys.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not relevant for this type of device.
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:
- This information is not provided and is completely irrelevant as this is a dental alloy, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not provided and is completely irrelevant as this is a dental alloy, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not provided and is not relevant in the traditional sense for this type of device. "Ground truth" for a dental alloy would relate to its material properties and clinical performance, likely assessed through physical and chemical testing and clinical outcomes, but not described in detail here in a 510(k) summary.
The sample size for the training set:
- This information is not provided and is not relevant for this device. "Training sets" are used for machine learning models.
How the ground truth for the training set was established:
- This information is not provided and is not relevant for this device.

In summary:

This document is a regulatory submission for a dental alloy. The "study" referenced in the context of substantial equivalence is the comparison to a legally marketed predicate device and demonstrating compliance with international and European standards for dental materials. It does not involve the detailed performance studies, expert reviews, or AI/ML evaluations that your questions imply for a different category of medical device.

Summary

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SEP 17 2002 (022467)

Premarket Notification 510(k)

Porta IP Solder V-2

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:	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: PORTA IP SOLDER V-2

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

Alloy, gold based, for clinical use EJT 872.3060 Class II

Legally marketed equivalent device: Argesol 600 510(k) number: K 954360

Device description

Porta IP Solder V-2 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 solder before firing for dental ceramic alloys with appropriate melting ranges and compositions, especially Porta Geo Ti, Porta SMK 82, Portalloy 54, and Simidur S1S and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.

Porta IP Solder V-2 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 7 2002

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

Re: K022467

Trade/Device Name: Porta IP Solder V-2 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 vour 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 (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

Timothy A. Ulatowski

Timoth A. 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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Page 1 of 1

510(k) Number orta IP Solder V-2

Device Name:_

Indications For Use:

Porta IP Solder V-2 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.

It 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)

RShetz DDS for Dr. Susan Kummer

on of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number: K022467

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Prescription Use_ (Per 21 CFR 801.109) 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.