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The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient's teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a "before" view and an after "view" of the patient's mouth for visual confirmation of dental procedure results.

The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.

The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth.

This FDA 510(k) letter for the ElcaCam Intraoral Camera is a determination of substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone performance (algorithm only) study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the regulatory determination of substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results.

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