(90 days)
UniSight™ system with UniGate™ is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
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The provided FDA document (K023394) is a 510(k) clearance letter for the "EBM UniSight™ System with UniGate™". This document is a regulatory approval letter and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device receives digital images and data from various sources, and images and data can be stored, communicated, processed, and displayed. The nature of the device (Picture Archiving and Communications System - PACS) suggests that its performance would typically be evaluated based on:
- Image fidelity and integrity: Ensuring images are not corrupted or degraded during transmission, storage, and display.
- Data integrity: Ensuring patient data and image metadata are accurately preserved.
- Communication speed and reliability: How quickly and consistently images and data can be moved within the system and across networks.
- Display accuracy: Whether the displayed images accurately represent the original acquired images (e.g., resolution, contrast, brightness).
- System uptime and reliability.
- Compliance with imaging standards (e.g., DICOM).
However, the provided text does not include any of the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- Results of MRMC comparative effectiveness studies.
- Standalone performance studies.
- Types of ground truth used or how ground truth was established for either test or training sets.
Therefore,Based on the information provided in the given document, I cannot answer the question. The document is an FDA 510(k) clearance letter for a Picture Archiving and Communications System (PACS) and does not detail the acceptance criteria or a study proving the device meets those 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).