(79 days)
EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public.
EagleSoft's ChairSide is a clinical software program that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audio recordings, and clinical exam data. In addition, it also offers an imaging module for image acquisition, editing, and storage of digital images. It is designed to be a single-source solution for a dentist's software needs for clinical and diagnostic use when serving the general public. Images can be acquired from standard dental imaging devices including Digital Radiographic Devices, Digital Video Capture Devices, and Generic Image Devices such as scanners. Nondiagnostic images can then be edited (i.e. resized, contrast, cropped, etc.). Images can also be easily imported and exported.
The provided FDA 510(k) document is a clearance letter for the EagleSoft ChairSide Software Application, dated September 30, 1998. It states that the device is substantially equivalent to devices marketed prior to May 28, 1976, and outlines the general controls and regulations that apply. The "Statement of Indication For Use" (Form 8.0) describes the software's capabilities, including keeping records, treatment plans, clinical notes, and an imaging module for acquisition, editing, and storage of digital images from various dental imaging devices.
Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets said criteria. The 510(k) clearance process at the time for a device of this nature primarily focused on demonstrating substantial equivalence to a predicate device, which often did not require extensive clinical performance studies or specific quantitative acceptance criteria in the same way device clearances might today, especially for AI/ML-based devices.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document describes a software application for managing dental records and images, with an imaging module for acquisition, editing, and storage of nondiagnostic images. The focus here is on functionality, integration, and equivalence for file management and nondiagnostic image manipulation, rather than diagnostic accuracy or performance against specific clinical endpoints.
§ 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).