(30 days)
The Image-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. .
Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
Image-Arena is an SQL database based image management system that provides the capability to import, export, store, retrieve and report digital studies.
lmage Arena is developed as a common interface platform for TomTec - and commercially available analysis and quantification tools (= clinical application packages) that can be connected to Image-Arena through the Generic Clinical Application Package interface (= Generic CAP Interface)
lmage-Arena manages different digital medical data from different modalities except digital mammography.
Image-Arena is suited as stand-alone workstation as well as networked multisystem server / client installations.
Image-Arena runs on an integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Image-Arena provides the possibility to create user defined medical reports.
The system does not produce any original medical images.
Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Echo-Com is a clinical application package software for reviewing and reporting of digital stress echo data. Echo-Com is either embedded in Image-Arena Platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Image-Arena and Image-Arena Applications (Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5) device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it relies on a qualitative comparison to predicate devices and general statements about safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is as safe as predicate device. | "The clinical test results support the conclusion that the device is as safe as effective..." |
| Device is as effective as predicate device. | "...and performs as well as or better than the predicate device." |
| Device performs as well as or better than predicate device. | "...and performs as well as or better than the predicate device." |
| Software testing and validation completed successfully. | "Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release." |
| Overall product concept is clinically accepted. | "The overall product concept was clinically accepted..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any clinical test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). It simply states "clinical test results."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention if an MRMC comparative effectiveness study was done, or any effect size of human readers improving with AI vs. without AI assistance. The device described is an image management and analysis system, not an AI-assisted diagnostic tool in the sense of directly improving human reader performance on a task. Its role is to provide tools for reviewing, measuring, and reporting, which could indirectly improve efficiency or consistency but this is not quantifiable in the provided text as an "effect size" of AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The document does not present any standalone (algorithm only) performance data. The device is described as an image management and analysis system, implying human interaction for reviewing, measuring, and reporting.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for any clinical testing. Given that it's an image management and analysis system, it's likely that if any ground truth was established for "clinical test results," it would be based on expert clinical interpretation or existing patient records, but this is not explicitly stated.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This type of device is an image management and analysis platform, not a machine learning model that typically involves distinct training sets for algorithm development in the way that, for example, a CAD system would.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 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).