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510(k) Data Aggregation
(30 days)
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
The Image-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. .
Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
Image-Arena is an SQL database based image management system that provides the capability to import, export, store, retrieve and report digital studies.
lmage Arena is developed as a common interface platform for TomTec - and commercially available analysis and quantification tools (= clinical application packages) that can be connected to Image-Arena through the Generic Clinical Application Package interface (= Generic CAP Interface)
lmage-Arena manages different digital medical data from different modalities except digital mammography.
Image-Arena is suited as stand-alone workstation as well as networked multisystem server / client installations.
Image-Arena runs on an integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Image-Arena provides the possibility to create user defined medical reports.
The system does not produce any original medical images.
Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Echo-Com is a clinical application package software for reviewing and reporting of digital stress echo data. Echo-Com is either embedded in Image-Arena Platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Image-Arena and Image-Arena Applications (Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5) device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it relies on a qualitative comparison to predicate devices and general statements about safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is as safe as predicate device. | "The clinical test results support the conclusion that the device is as safe as effective..." |
| Device is as effective as predicate device. | "...and performs as well as or better than the predicate device." |
| Device performs as well as or better than predicate device. | "...and performs as well as or better than the predicate device." |
| Software testing and validation completed successfully. | "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." |
| Overall product concept is clinically accepted. | "The overall product concept was clinically accepted..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any clinical test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective). It simply states "clinical test results."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention if an MRMC comparative effectiveness study was done, or any effect size of human readers improving with AI vs. without AI assistance. The device described is an image management and analysis system, not an AI-assisted diagnostic tool in the sense of directly improving human reader performance on a task. Its role is to provide tools for reviewing, measuring, and reporting, which could indirectly improve efficiency or consistency but this is not quantifiable in the provided text as an "effect size" of AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The document does not present any standalone (algorithm only) performance data. The device is described as an image management and analysis system, implying human interaction for reviewing, measuring, and reporting.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for any clinical testing. Given that it's an image management and analysis system, it's likely that if any ground truth was established for "clinical test results," it would be based on expert clinical interpretation or existing patient records, but this is not explicitly stated.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This type of device is an image management and analysis platform, not a machine learning model that typically involves distinct training sets for algorithm development in the way that, for example, a CAD system would.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth might have been established.
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(40 days)
IMAGE-ARENA APPLICATIONS
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."
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(33 days)
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
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(48 days)
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
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.
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