(33 days)
The Image-Arena VA Platform software is intended to serve as a data management platform for clinical application packages. As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.
The Image-Arena Applications are a software tool package designed for analysis. documentation and archiving of ultrasound and magnetic resonance studies in multiple dimensions. The Image-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 Image-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) 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.
The provided text is a 510(k) summary for the TomTec Image-Arena Applications. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving device performance.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The document states, "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." However, it does not explicitly define quantitative acceptance criteria or provide a table of performance metrics.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The general criteria appear to be "as safe as effective, and performs as well as or better than the predicate device." | The document states that "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." No specific performance metrics or quantitative results are provided. |
Study Details
Here's a breakdown of the requested study information based on the provided text:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Missing: The document states that "clinical test results support the conclusion that the device is as safe as effective," but it does not specify the sample size of the test set, the country of origin of the data, or whether the study was retrospective or prospective.
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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):
- Information Missing: The document does not provide any details about the number of experts, their qualifications, or how ground truth was established for the clinical testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Missing: The document does not describe any adjudication method used for the test set.
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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:
- Information Missing: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a software tool package for analysis, documentation, and archiving. The primary focus of the 510(k) is demonstrating substantial equivalence, not necessarily an improvement in human reader performance with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Information Missing: While the device is "a software tool package designed for analysis, documentation, and archiving," the 510(k) summary does not explicitly describe a standalone algorithm-only performance test or present its results in isolation from a human workflow. The comparison is generally against predicate devices which also involve human interaction with the software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information Missing: The document does not specify the type of ground truth used for the clinical performance evaluation.
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The sample size for the training set:
- Information Missing: The document does not mention a training set sample size. This type of detail is often critical for machine learning-based devices, but the provided text focuses on the device's function as an imaging analysis, documentation, and archiving platform, suggesting its core functionality might not be a deep learning model that requires a distinct "training set" in the common sense, or if it is, the details are not disclosed here.
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How the ground truth for the training set was established:
- Information Missing: As no training set is described, there's no information on how its ground truth might have been established.
Summary of what is present:
- Non-clinical performance data: "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." This indicates internal testing processes but no specific metrics or study details.
- Clinical performance data: "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." This is a general statement of conclusion, not a detailed study report.
In conclusion, this 510(k) summary provides a high-level overview of the device and claims of substantial equivalence but lacks the detailed study information, specific acceptance criteria, and quantitative performance measures requested. This is typical for many 510(k) summaries which focus on demonstrating equivalence rather than a full clinical trial report with detailed performance metrics.
§ 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).