(76 days)
Acquire, store, transmit, and display medical images and patient reports of various types. Teleradiology image acquisition, distribution, archive and viewing.
The ISSA™ Imaging and PHAROS Communication Products is a lightly integrated package of software elements designed to provide:
- DICOM compliant telemedicine viewer interface
- 2D viewer of all stored medical images .
- . Telemedicine communication system
In general terms, Issa PHAROS contains two software applications, Issa and Pharos. Both belong to the group of software produsts for medical image management and manipulations are designed to fit equaly to small medical units, such as imaging clinics or general practice clinics, and to large medical units such as hospitals or hospital departments. Image management and manipulation here means acquisition, archival, processing and transmission or distribution.
The provided text is a 510(k) Premarket Notification for the ISSA™ Imaging and PHAROS Communication Products. This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).
The document states:
- "There are no applicable FDA mandated performance standards for this device."
- "The software described in the submission was developed, tested and validated in accordance with written Verification and Validation procedures."
- "No known hazardous procedures were detected during verification and testing that would be the consequence of software operation."
This indicates that while internal verification and validation were performed, no specific performance metrics or clinical study results are presented in this public summary to address the questions asked. The document is primarily a regulatory filing for substantial equivalence based on design and intended use, not a detailed technical performance report.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, or ground truth based on the provided text.
§ 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).