(48 days)
The Image-Arena and Research-Arena Platform Software is intended to serve as a data management platform for clinical application packages. As the Image-Arena and Research-Arena Applications software tool package is modular structured, the clinical applications packages are indicated as software packages for analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle in all patients with a need of right heart function diagnosis.
The Image-Arena/Research-Arena Applications are a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions. The Image-Arena/Research-Arena Applications 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. 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 new Image-Arena/Research-Arena Applications offer 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) as well as analogue video acquisition 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 B-mode, 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 document is a 510(k) summary for the TomTec Imaging Systems GmbH Image-Arena Platform 3.x and related applications. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria, clinical studies, or performance metrics in the format requested.
The document mainly states that:
- "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."
- "Test results support the conclusion, that the device is as safe as effective, and performs as well as or better than the predicate device."
Therefore, many of the requested fields cannot be filled based on the provided text. The document describes a general software update/combination of previously cleared systems, and the performance testing appears to be primarily focused on confirming the software functions as intended and is equivalent to the predicate device, rather than presenting specific quantitative clinical performance metrics as might be found in a novel device's clinical trial results.
Here is an attempt to answer the questions based only on the provided text, with most fields marked as "Not provided in the document."
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: "as safe as effective, and performs as well as or better than the predicate device") | "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 the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided in the document.
- Data Provenance: Not provided in the document.
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)
- Number of Experts: Not provided in the document.
- Qualifications of Experts: Not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: 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
- MRMC Study: Not provided in the document. The document refers to "clinical test results" and "clinical acceptance" but does not detail comparative effectiveness studies of human readers with/without AI assistance.
- Effect Size: Not applicable/Not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not explicitly stated as a separate study. The document states "Software testing and validation were done at the module and system level," which implies internal validation. It does not provide standalone performance metrics for the algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not provided in the document. "Clinical test results" are mentioned, but the method for establishing ground truth is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided in the document. This document describes a software update/combination of existing software modules; it does not detail the development or training of a new AI algorithm.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable / Not provided in the document.
§ 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).