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Auropal 1 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/Onlays - Partial crowns - Crowns - Short span bridges - Long span bridges - Removable partials and can be used for - Telescopic and milling work

Auropal 1 is an extra-hard gold-silver casting alloy (67% noble metals), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Auropal 1 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text is a Premarket Notification 510(k) for a dental alloy named "Auropal 1." 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, a study proving the device meets those criteria, or any of the detailed aspects requested in the prompt related to device performance evaluation (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training sets).

The 510(k) submission for this type of device (a dental alloy) primarily focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It typically relies on existing standards (like ISO 8891 mentioned) and material properties rather than clinical performance studies with specific acceptance criteria in the way medical imaging AI or diagnostic devices would.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and performance studies because that information is not present in the provided document.

To summarize, for this specific document:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not applicable/available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available.
4. Adjudication method: Not applicable/available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/available.
6. Standalone (algorithm only) performance: Not applicable/available.
7. Type of ground truth used: Not applicable/available.
8. Sample size for the training set: Not applicable/available.
9. How the ground truth for the training set was established: Not applicable/available.

The document indicates that Auropal 1 "fully complies to the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This compliance with standards would be the primary "proof" of its characteristics for this type of device, rather than a clinical performance study with the metrics you've asked about.

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