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The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies.

The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.

The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore 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, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Windows 2000 Professional™ Operating System standards. 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 lines Echo-View and Echo-Com and Siemens Axius™ software 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/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-, 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 510(k) summary for the TomTec Imaging Systems Image-Arena/Research-Arena Applications does not contain the detailed information necessary to answer all parts of your request. This document is focused on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics, rather than providing a detailed report on a specific performance study with acceptance criteria.

While the document states that "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," it does not provide the specifics of these tests.

However, I can extract what is available and indicate where information is missing:

Acceptance Criteria and Study for TomTec Image-Arena/Research-Arena Applications

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or the numerical results from performance tests. It relies on a general statement of conformance to internal specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document only mentions "Software testing and validation were done at the module and system level."
• Data Provenance: Not specified. It's unclear if the test data was retrospective or prospective, or its country of origin. Given the company is German-based, it's possible some data was from Germany, but this is an inference.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified. The document states "Test results were reviewed by designated technical professionals," but does not specify their number, roles, or qualifications (e.g., radiologists, cardiologists).
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document only indicates review by "designated technical professionals." No details on how discrepancies or disagreements were handled are provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, this document does not describe an MRMC comparative effectiveness study. The device is a "software tool package designed for analysis, documentation and archiving" and an "image management system," not an AI diagnostic algorithm meant to directly improve human reader performance in interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance would not be directly applicable or expected for this type of device.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes, implicitly. The document describes "Software testing and validation were done at the module and system level." This implies that the software's functionality, such as image import, processing, measurement capabilities, and archiving, was evaluated for its accuracy and functionality in isolation, conforming to its "design intent" and "system performance specifications." However, no specific details or results of these standalone tests are provided, particularly for advanced analysis features like "Axius Quantitative Strain Rate Imaging" or "Axius Edge Assisted Ejection Fraction."

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. For a software suite of this nature, ground truth would likely refer to objective verification of its functionality (e.g., successful import/export, accurate calculation of measurements against known inputs, proper archiving and retrieval) rather than clinical diagnostic ground truth like pathology or outcomes data. If clinical features like "Axius Edge Assisted Ejection Fraction" involve automated measurements, the ground truth would be precise, independently verified measurements from the images, potentially established by expert consensus or comparison to gold standard techniques. However, this is not detailed.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) summary describes a software platform and applications that combine functionalities of previously cleared devices and update them for new operating systems. There is no indication that this specific submission involves a machine learning algorithm requiring a "training set" in the modern sense. It appears to be rule-based or algorithmic, rather than data-driven AI that learns from a large training dataset.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a traditional "training set" for a machine learning model, the establishment of ground truth for such a set is not discussed.

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