(88 days)
The Image-Arena Platform Software is intended to serve as a data management platform for clinical application packages. It provides information that is used for clinical diagnosis purposes.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology.
As the Image-Arena Applications software tool package is modular structured, clinical applications packages with different indications for use can be connected.
Echo-Com software is intended to serve as a versatile solution for Stress Echo examinations in patients who may not be receiving enough blood or oxygen because of blocked arteries.
Image-Com software is intended for reviewing, measuring and reporting of DICOM data of the cardiac modalities US and XA. It can be driven by Image-Arena or other third party platforms and is intended to launch other clinical applications.
The clinical application package 2D Cardiac Performance Analysis is indicated for cardiac quantification based on echocardiographic data. It provides measurements of myocardial function (displacement, velocity and strain) that is used for clinical diagnosis purposes of patients with suspected heart disease.
The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Vista™ Operating System standards.
Image-Arena is suited as stand-alone workstation as well as networked multisystem installations. Image Arena is developed as a common interface platform for TomTec and 3rd party clinical application packages that can be connected to Image-Arena through the 300 party Interface. The different application packages have all access to the central database and can be enabled on a modular basis thus allowing custom tailored solutions of Image-Arena.
The Image-Arena Application is a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions and X-ray angiography studies.
The Image-Arena Application software tools are modular structured and consist of different software modules. The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician.
The Image-Arena Application offers features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-,TomTec-file formats) in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used.
Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including 2D. M-Mode. Pulsed (PW) Doppler Mode, Continuous (CW) wave Doppler Mode, Power Amplitude Doppler Mode, Color Doppler Mode, Doppler Tissue Imaging and 3D/4D imaging modes.
2D Cardiac Performance Analysis 1.0 is an additional clinical application package for high performance PC platforms based on Microsoft Windows™ operating system standards. 2D Cardiac Performance Analysis 1.0 is a software for the analysis, storage and retrieval of digitized ultrasound B-mode images. The data can be acquired by ultrasound machines that are able to acquire and store 2D ultrasound datasets. The digital 2D data can be used for comprehensive functional assessment of the myocardial function.
2D Cardiac Performance Analysis 1.0 is designed to run with a TomTec Data Management Platform for offline analysis. The TomTec Data Management Platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes.
2D Cardiac Performance Analysis 1.0 is designed for the 2-dimensional functional analysis of myocardial function. Based on two dimensional datasets a speckle tracking algorithm supports the calculation of a 2D contour model that represents the endocardial and epicardial border. From that contours the corresponding velocities, displacement and strain can be derived.
The 2D Cardiac Performance Analysis 1.0 application is a visual and quantitative method for assessing cardiac mechanics and the dynamics of cardiac motion.
The document lacks specific acceptance criteria (performance metrics with thresholds) and detailed study results to confirm the device meets these criteria. The approval is based on substantial equivalence to predicate devices, not on a detailed comparative effectiveness study with specific performance outcomes.
Here's an attempt to answer the questions based on the provided text, while highlighting the missing information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed performance metrics are provided in the document. The submission states that "Test results support the conclusion, that the subject device is as safe as effective, and performs as well as or better than the predicate devices," but no specific data is given.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical test results" but does not provide any details regarding the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document mentions that "The overall product concept was clinically accepted and the clinical test results support the conclusion that the subject device is as safe as effective, and performs as well as the predicate devices." However, it does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human reader improvement with or without AI assistance. The focus seems to be on demonstrating equivalence to predicate devices rather than measuring improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the "2D Cardiac Performance Analysis 1.0" software as calculating parameters based on a "manual drawn contour" by a prerequisite user, suggesting a human-in-the-loop component for defining initial contours. Therefore, a purely standalone algorithm performance without human interaction is not explicitly described or implied.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for evaluating the device's performance.
8. The sample size for the training set
The document does not provide any information about a training set or its sample size.
9. How the ground truth for the training set was established
The document does not provide any information about a training set or how its ground truth was 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).