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CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient.

CADI is a prescription use only product, intended to be used by dental professionals only.

CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner. It is a modular software with the following modules: Digital x-ray module, Intraoral Camera Module, Digital Camera Module, Cosmetic and Whitening Module, Natural Smiles Library, and Orthocephalometric Tracing (DFO) Module.

This document is a 510(k) clearance letter for a dental imaging software called CADI, version 4. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text.

Here's why the requested information is not present:

• Acceptance Criteria and Reported Performance: The document does not define any specific performance metrics or acceptance criteria for the CADI software, nor does it present any data on the device's performance against such criteria.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The 510(k) clearance process often involves demonstrating substantial equivalence to a predicate device, rather than extensive clinical efficacy trials with detailed performance metrics. This document is the clearance letter, not the submission itself, and certainly not a detailed study report. Therefore, it does not include information about study design, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness.

The document generally describes the functions of the CADI software modules (x-ray viewer, intraoral camera, digital camera, cosmetic/whitening, natural smiles library, orthocephalometric tracing) and states its intended use by dental professionals for diagnostic purposes.

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