Search Results

Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta SMK 82 can be veneered with suitable dental ceramics as well as with dental composites.

Porta SMK 82 is a gold-palladium ceramic alloy with high contents of noble metals (90.5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta SMK 82 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Porta SMK 82 can be veneered with suitable dental ceramics and with dental composites.

This 510(k) premarket notification for Porta SMK 82, a gold-palladium ceramic alloy, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Deva Plus K K921419) and outlining the device description, indications for use, and general regulatory information.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: This document states that the device "fully complies to the international standard ISO 9693" and "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not provide a table outlining specific acceptance criteria from these standards (e.g., tensile strength, corrosion resistance thresholds) or the measured performance of Porta SMK 82 against those criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
5. 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 device is a dental alloy, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a dental alloy, not a software algorithm, this is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned. For a material like this, "ground truth" would likely relate to material property testing (e.g., mechanical testing, corrosion testing) against established standards.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

In summary, the provided document acts as a 510(k) submission showing that the Porta SMK 82 dental alloy is substantially equivalent to a predicate device and meets relevant international standards. However, it does not include the detailed study design, acceptance criteria, and performance data typically found in submissions for devices requiring such evidence, particularly for AI/ML or diagnostic tools.

Ask a specific question about this device