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This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.

This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy.

I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving device adherence to such criteria is not available. This document is a 510(k) K033356 clearance letter from the FDA for Verasoft ES, a dental alloy.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the device was cleared based on its substantial equivalence to an already legally marketed predicate device, as per the 510(k) pathway. This pathway typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and studies demonstrating that the device meets those criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "Indications For Use" section simply defines the device as a "non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices." This describes the intended use but does not provide specific performance metrics or acceptance criteria as you've outlined.

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