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Porta Solder 1090 W 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

Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%). Porta Solder 1090 W 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 ceramic dental alloys with appropriate melting ranges and compositions, especially Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Solder 1090 W 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.

The provided text describes a 510(k) premarket notification for a dental brazing alloy called "Porta Solder 1090 W." The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/SaMD device are not applicable to this document. The document describes a traditional medical device (a dental alloy).

Here's an analysis based on the information provided, highlighting the sections that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as this is a dental alloy, not an AI/SaMD device that would typically have a "test set" in the context of algorithm performance. The "study" referenced in the document is the process of comparing the Porta Solder 1090 W to its predicate device, Argesol-WSF (K 942505), to establish substantial equivalence based on material properties and intended use. There is no mention of a "test set" of patients or data in the way an AI study would define it.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The "ground truth" for a dental alloy typically refers to its physical, chemical, and mechanical properties, as measured by standardized tests, and its compliance with industry standards (like ISO 9333) and regulatory requirements. It is not established by expert consensus on clinical findings in the same vein as an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" of clinical cases requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks. This device is a dental alloy for fabrication, not a diagnostic tool where human readers interact with AI.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

This information is not applicable. This device is a physical dental alloy, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on:

• Material Science and Engineering Properties: Chemical composition, melting range, corrosion resistance, and mechanical properties determined through laboratory testing according to established international standards (e.g., ISO 9333).
• Regulatory Compliance: Meeting the essential requirements of the European directive 93/42/ECC and demonstrating substantial equivalence to a legally marketed predicate device (Argesol-WSF).

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for a physical dental alloy in the context of an algorithmic device. The term "training set" is generally used for machine learning models.

9. How the Ground Truth for the Training Set Was Established

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

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