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This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device. The document is an FDA 510(k) clearance letter for a dental alloy named "Continum™ V," confirming its substantial equivalence to a legally marketed predicate device. It addresses regulatory information, marketing authorization, and general compliance requirements, but it does not include performance studies or validation data.

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This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.

This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.

I apologize, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Aalba Dent, Incorporated for their Continum™ dental alloy. It primarily confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample sizes, data provenance, or retrospective/prospective study design.
3. Information on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
6. Data on standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states the device name (Continum™), its regulation name (Base Metal Alloy), regulatory class (Class II), and its intended use (a non-precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crowns and bridges). It indicates that the FDA has determined the device to be substantially equivalent.

Ask a specific question about this device