(52 days)
Oryx Cloud Imaging is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
Oryx Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any Mac or PC with an active internet connection. Oryx Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. Oryx Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. Oryx Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using Oryx Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files. Oryx Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors, intraoral cameras, and scanners. Oryx Cloud Imaging is imaging software designed for use in dentistry. The main Oryx Cloud Imaging software functionality includes image acquisition, organization. Oryx Cloud Imaging is used by dental professionals for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Dentists and other qualified individuals can display and review images, apply annotations, and manipulate images. Oryx Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing. The software operates upon standard PC hardware and displays images on the PC's connected display/monitor. The subject device is the Oryx PACS software; the computer or the monitor are not part of the submission.
The provided text describes the 510(k) summary for Oryx Cloud Imaging, a dental image management software. It states that the device is substantially equivalent to a predicate device based on its intended use, indications for use, and technological characteristics, and that non-clinical testing was conducted to ensure its reliability. However, this document does not contain specific acceptance criteria, detailed study results, or the methodology (e.g., sample size, expert qualifications, or ground truth establishment) of a study proving the device meets performance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor details about the sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. The document states that "Software verification and validation testing" and "Clinical Expert Evaluation" were part of the non-clinical testing, but it does not provide the specifics of these evaluations.
The closest information provided related to performance or testing is:
V. SUMMARY OF NON-CLINICAL TESTING
Oryx Dental Software INC. has conducted extensive non-clinical and validation testing of the Oryx Cloud Imaging, as a PACS system that is capable of providing reliable post-processing and display of images for dental applications. All of the different components of the Oryx Cloud Imaging software have been tested to ensure that the system as a whole provides all the capabilities necessary to operate in a manner substantially equivalent to the predicate device.
The tests performed included:
- Software Risk Assessment
- Software verification and validation testing
- Clinical Expert Evaluation
§ 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).