(27 days)
VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.
VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.
This 510(k) submission for VISTADENT™ AT COMPLETE is a premarket notification for an imaging database software and does not contain information related to an AI/ML medical device performance study, acceptance criteria, or an MRMC comparative effectiveness study. The device is described as software for storing, organizing, manipulating, and analyzing orthodontic patient digital images and x-ray records, including cephalometric analysis with auto-tracing and virtual treatment objectives.
Therefore, I cannot provide the requested information from the provided text, as it does not include:
- Acceptance criteria and reported device performance: The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for an AI/ML component.
- Sample size and data provenance for a test set: No test set is described.
- Number and qualifications of experts for ground truth: No ground truth establishment process is mentioned for evaluation.
- Adjudication method for the test set: Not applicable as no test set is described.
- MRMC comparative effectiveness study: This type of study is not mentioned. The features described (auto-tracing, virtual treatment objectives) suggest potential AI/ML capabilities, but no study evaluating human reader improvement with AI assistance is presented.
- Standalone performance study: No standalone performance study for an algorithm is discussed.
- Type of ground truth used: Not applicable as no performance evaluation study is detailed.
- Sample size for the training set: No training set is mentioned.
- How ground truth for the training set was established: Not applicable as no training set is described.
The document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices for a digital imaging database and analysis software, rather than reporting on the performance of a novel AI/ML algorithm against specific acceptance criteria.
§ 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).