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VarseoSmile Temp resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral light-curing equipment.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental resin product ("VarseoSmile Temp"). It outlines the regulatory clearance status, general controls provisions, and indications for use of the device.

However, it does not include any details about:

• Acceptance criteria for device performance (beyond general regulatory compliance)
• Specific "device performance" metrics or reported results
• Sample sizes used for testing
• Data provenance (country of origin, retrospective/prospective)
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size or how its ground truth was established

The document primarily focuses on the administrative and regulatory aspects of the device's clearance.

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