(93 days)
CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts, treatment plans, clinical notes, audit recording and clinical exam data. The system uses a Web-based interface and includes the editing and storage of digital images. The system is designed to be a single source solution for a dental practice.
Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images cannot be acquired from standard dental imaging devices, but can be uploaded directly from the user's computer. Images can be edited (e.g., resized, contrast, cropped, etc.), as well as exported.
Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.
Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called "Curve Hero". Curve Hero is a patient scheduling and billing application that is provided as a stand-alone or in combination with Curve Image. Curve Hero is not a medical device and therefore is outside the scope of this submission.
The provided text describes a 510(k) summary for the "Curve Image" device, a Picture Archiving and Communications System (PACS) for dental offices. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The text focuses on:
- Establishing substantial equivalence to predicate devices (ChairSide Software Application and Centricity PACS Web Diagnostic).
- Describing the device's intended use and technical characteristics (web-based image management, editing, storage, etc.).
- Stating that "extensive non-clinical and validation testing" was conducted, including "Product Risk Assessment," "Software modules verification tests," and "Software validation test."
Therefore, I cannot provide the requested information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria based on the provided text. The document does not detail specific performance metrics, test results against those metrics, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
The document is a regulatory submission focused on demonstrating substantial equivalence for marketing clearance, not a detailed technical report on performance testing outcomes against predefined 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).