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B-System Silicone is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

The device is a condensation cured silicone impression material designed to be used for full dentures, partial dentures, inlays, onlays, crowns and bridges.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and an FDA clearance letter for a dental impression material named "B-System Silicone," which focuses on establishing substantial equivalence to a predicate device for market clearance.

The text does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes or data provenance for any test set.
• Information on the number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set sample size or how its ground truth was established.

The content primarily describes the device, its intended use, and its substantial equivalence to another legally marketed device, which is the basis for its FDA clearance.

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