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Non-diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

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This document is a 510(k) premarket notification letter from the FDA for a dental operative unit and accessories (Trade/Device Name: Spirit/DocPortMacro). It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for AI/ML-based medical devices.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It pertains to a physical dental device, not software or an AI/ML product. Therefore, I cannot extract the requested information from the provided text.

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