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AdvanceCAM intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in decribing the dental procedure being performed as well as showing the results

AdvanceCAM Intra Oral Camera System and Accessories

The provided text is a 510(k) premarket notification letter from the FDA to TPC Advanced Technology, Incorporated, concerning their "AdvanceCAM Intra Oral Camera System and Accessories." This document primarily establishes that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or details regarding the training set for an AI/algorithm.

The letter focuses on regulatory approval based on substantial equivalence to existing devices. It lists the components of the AdvanceCAM system and states its intended use: "to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results."

Therefore, I cannot provide the requested information from this document. The sections of your request that a typical AI/algorithm medical device submission would include are entirely absent from this 510(k) clearance letter for an intraoral camera system.

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