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The MaxCure9 is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light.

This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.

The provided text is a 510(k) summary for the MaxCure 9 Curing Light. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific performance acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, the information required to answer your questions about acceptance criteria for AI performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document.

The document primarily addresses:

• Device Description: The MaxCure 9 is a curing light used to polymerize dental materials.
• Comparison to Predicate: It compares the MaxCure 9 to the D-Lux+ predicate device, highlighting similarities and differences in features, specifications, and operation.
• Performance Data (Non-clinical): It lists the non-clinical tests performed, including biocompatibility, software validation, and electrical safety/EMC standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Conclusion: It states that based on the similarities and test results, the device is substantially equivalent to the predicate.

In summary, this document is for a traditional medical device (a curing light), not an AI/SaMD. As such, the information you've requested regarding AI acceptance criteria and study details is not applicable to this specific submission.

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