(40 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 Image-Arena Application is a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions and Xray angiography studies.
The Image-Arena Application software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product line Image-Arena Applications and Research-Arena Applications ( K071232) and Xcelera (K061995). 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.
The provided 510(k) summary for TomTec Imaging Systems' Image-Arena Applications (K083348) describes general software testing and clinical acceptance rather than specific, quantifiable acceptance criteria or a detailed study demonstrating device performance against such criteria.
Here's a breakdown of the information that can and cannot be extracted from the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific, quantifiable acceptance criteria and their corresponding reported device performance values are NOT explicitly stated. The document refers to general software testing and clinical acceptance.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly defined in document | Not explicitly defined in document |
The document only states:
- "Testing was performed according to internal company procedures. 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."
- "The overall product concept was clinically accepted and the clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "clinical test results."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of experts: Not specified.
- Qualifications of experts: Not specified. The document only mentions "designated technical professionals" reviewing test results and "clinical acceptance" without detailing who provided this acceptance or their credentials.
4. Adjudication Method for the Test Set
- Adjudication method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC study conducted: No. The document does not mention any MRMC study or comparison of human reader performance with and without AI assistance. The device is a general image management and processing tool, not explicitly an AI-assisted diagnostic tool in the sense of directly improving human reader performance on a diagnostic task through AI.
6. Standalone (Algorithm Only) Performance Study
- Standalone performance study: No. The document details the software as an "Image-Arena Application," a "software tool package designed for analysis, documentation and archiving," and an "image management system." It's not described as an algorithm with a standalone diagnostic performance metric. Its performance is implicitly tied to its functions as a platform for displaying, managing, and performing offline measurements on images.
7. Type of Ground Truth Used
- Type of ground truth: Not specified. The document only refers to "clinical acceptance" and "clinical test results," but does not detail how the "truth" against which these tests were assessed was established (e.g., expert consensus, pathology, long-term outcomes).
8. Sample Size for the Training Set
- Sample size for the training set: Not applicable/Not specified. This device is described as an image management and analysis platform, not a machine learning model that would typically have a "training set."
9. How Ground Truth for the Training Set Was Established
- How ground truth was established for the training set: Not applicable/Not specified, as there is no mention of a training set for a machine learning model.
In summary, the provided 510(k) pertains to a software platform for image management and analysis, not a device with specific AI algorithms requiring detailed performance metrics regarding diagnostic accuracy or clinical effectiveness studies in the modern sense of AI/ML-enabled devices. The clearance is based on demonstrating substantial equivalence to predicate devices (K071232 and K061995) for its functions of retrieving, storing, analyzing, and reporting digital ultrasound and XA studies, and for being a general-purpose digital medical image processing tool. The performance data mentioned is related to general software validation and clinical acceptance of the overall product concept as being "as safe as effective, and performs as well as or better than the predicate device."
§ 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).