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Porta OP Solder W-2 is intended for use as a secondary solder for dental casting alloys, as well as a solder after firing for dental ceramic alloys, 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.

Porta OP Solder W-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 high contents of precious metals (Gold, Platinum and Silver: 88,0%). Porta OP Solder W-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 for use as primary solder for dental casting alloys, and as solder after firing for dental ceramic alloys should have appropriate melting ranges and compositions, especially recommended are AGC® Special alloy, Porta Geo Ti, BioPorta G, Porta SMK 82, Portalloy 54, Euro 50, DuoPal 6, Simidur S1S, Simidur S2, Simidur KF plus, BioPortadur, Portadur P 2, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta OP Solder W-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.

The provided text is a 510(k) summary for a dental brazing alloy, Porta OP Solder W-2. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance testing against quantitative metrics or human clinical effectiveness.

The document discusses compliance with:

• ISO 9333: International standard for dental brazing alloys.
• European directive 93/42/ECC: Concerning medical devices.
• The device's high corrosion resistance.

These are regulatory and material standards, but the document does not present them as "acceptance criteria" met by a "study" in the way one would describe a performance evaluation with specific data points for accuracy, sensitivity, specificity, or human reader improvement, as requested in the prompt.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, because this information is not present in the provided text. The text is a regulatory submission focused on substantial equivalence based on material composition and general compliance with existing standards, not on specific performance data from a clinical or analytical study as commonly described for AI/diagnostic devices.

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