(110 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).