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MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images.

When the quantified results provided by MR-CT VVA are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

MR-CT VVA (MR-CT Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of MR and CT images of blood vessels, of the heart and MR images of the liver and cerebral spinal fluid. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen and can be exported in various electronic formats.

MR-CT VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.

MR-CT VVA has a modular structure that consists of its previously cleared predicate devices: MRI-MASS, CT-MASS, MRI-FLOW, CMS-VIEW and MRA-CMS. MR-CT VVA comprises their respective functionalities for analyzing the blood vessels and the heart. In addition, MR-CT VVA includes new functionality for the 3D review of MR volumetric data.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria. It primarily focuses on the regulatory submission process and the substantial equivalence to predicate devices.

However, I can extract information related to the device description, intended use, and general statement about testing and validation.

Here's an attempt to answer your request based on the available text, with caveats for missing information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list specific acceptance criteria in a table format nor does it provide a table of reported device performance metrics against those criteria. It broadly states that "Testing and validation have produced results consistent with design input requirements."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.

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)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device is described as providing "more reproducible than manually derived quantified results," implying an improvement over manual methods, but no study details are given.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states: "MR-CT VVA has been developed as a standalone application to run on a Windows based operating system." This confirms that a standalone algorithm is at the core of the device. However, regarding performance, it also mentions that analysis results are based on "contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing." This indicates that while the software has standalone capabilities for automatic detection, it's designed to be used with human review and potential editing, implying a human-in-the-loop component in its typical clinical use. Standalone performance data (algorithm only) is not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for testing or validation.

8. The sample size for the training set

The document does not provide information about the sample size used for the training set.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established.

Summary of available information related to performance and validation:

The document states:

• Device Description: "Semi-automatic contour detection forms the basis for the analyses."
• Intended Use: "These analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing."
• Indications for Use: "MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels..."
• Conclusions: "Testing and validation have produced results consistent with design input requirements. MR-CT VVA is a software-only device for which there no applicable mandatory performance standards." And "Medis concludes that MR-CT VVA is a safe and effective medical device, and is at least as safe and effective as its predicate devices."

In essence, the submission asserts that the device is safe, effective, and meets its design requirements, partly evidenced by its "more reproducible than manually derived quantified results." However, the specific study details (methodology, sample sizes, ground truth establishment, expert qualifications, and quantitative performance metrics against acceptance criteria) that would prove these claims are not present in the provided text. The submission relies heavily on demonstrating substantial equivalence to predicate devices rather than providing detailed de novo performance study results.

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cmr42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables:
Importing Cardiac MR Images in DICOM format
Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases.
Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass
Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images.
Flow quantifications based on velocity encodes images
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cmr42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public.
cmr42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.

cmr42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cmr42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac images for volume/mass, and flow quantification. It provides a comprehensive set of tools for the analysis of Cardiovascular Magnetic Resonance (CMR) images.

The provided 510(k) summary for the cmr42 Cardiac MR Software Application (K082628) describes its intended use and a general statement about testing but does not provide a detailed table of acceptance criteria or the specific results of a study proving the device meets these criteria.

Instead, the summary states:

"Description and Testing: cmr42 have been tested according to the specifications that are Conclusion of Testing documented in a Master Software Test Plan. Testing is an integral part of Circle Cardiovascular Imaging Inc software development process as described in the company's product development process."

"Conclusion: The successful non-clinical testing demonstrates the safety and effectiveness of the cm42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device."

This indicates that internal testing was conducted to specifications but the specific acceptance criteria and detailed performance metrics are not publicly available in this document. The submission focuses on demonstrating substantial equivalence to predicate devices (MRI-MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (MASS) K994283 and MRI-Flow Analytical Software K994282) rather than publishing detailed performance studies against explicitly stated acceptance criteria.

Therefore, for most of the requested information, the answer is "Not provided in the given document."

Here's a breakdown of what can be extracted or inferred based on the supplied text:

1. A table of acceptance criteria and the reported device performance:

• Viewing, panning, windowing, zooming
• Navigation through series/slices and phases | Demonstrated safety and effectiveness for qualitative analysis. |
  | Quantitative Measurements:
• Distance, area, volume, mass of heart and adjacent vessels
• LV function, cardiac output, cardiac index from long and short axis images | Demonstrated safety and effectiveness for quantitative measurements; performs "as well as or better than" predicate devices. |
  | Flow Quantifications:
• Based on velocity encoded images | Demonstrated safety and effectiveness for flow quantifications; performs "as well as or better than" predicate devices. |
  | Image Compatibility:
• Import DICOM-format Cardiac MR Images
• Images from all MRI scanner vendors supported | Functionality confirmed. |
  | User Interface and Functionality:
• Graphical user interface
• Comprehensive tool sets
• Dynamic display of ventricular contractions
• DICOM compliant networking
• Reports with visualization and quantitative parameters | Functionality confirmed and described as having "task specific modules with corresponding tool sets." |
  | General Performance:
• Safety and Effectiveness | Non-clinical testing demonstrates safety and effectiveness. Performs "as well as or better than" the legally marketed predicate devices. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided in the given document. The document only mentions "non-clinical testing" and testing "according to the specifications that are documented in a Master Software Test Plan." Specifics about the test set, its size, or its provenance are not included.

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):

• Not provided in the given document. The document does not describe the methodologies for establishing ground truth or the involvement of experts in the testing phase. The device itself is intended for use by "qualified medical professionals, experienced in examining and evaluating cardiovascular MR images."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not provided in the given document. No information on adjudication methods for establishing ground truth or evaluating test results is given.

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:

• No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. The submission focuses on the standalone performance of the software in comparison to predicate devices, not on human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone evaluation was implicitly done. The "cmr42" is described as a "software application" for viewing, post-processing, and quantitative evaluation. The testing described is "non-clinical testing" to demonstrate its safety and effectiveness and that it performs as well as or better than predicate devices. This implies evaluating the software's performance on its own capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not explicitly stated in the given document. Since the device performs quantitative measurements (distance, area, volume, mass), the ground truth for testing would likely involve highly accurate reference measurements, possibly derived from manual expert measurements, phantoms, or other validated methods. However, the specific type of ground truth is not detailed.

8. The sample size for the training set:

• Not applicable / Not provided. The cmr42 is described as an "Image Processing System" and "software application" for analysis. At the time of this 2008 submission, the focus for such devices was primarily on deterministic algorithms and user-driven analysis tools rather than AI/machine learning models that require distinct training sets. Therefore, a "training set" in the modern AI sense is unlikely to have been a component of its development or evaluation, and no such information is provided.

9. How the ground truth for the training set was established:

• Not applicable. As a training set is not mentioned, the method for establishing its ground truth is also not provided.

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The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.

The provided document does not contain acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it details a 510(k) premarket notification for the GE Delta Software Option for MRI, focusing on substantial equivalence to predicate devices and adherence to safety standards.

Here's a breakdown of what is and is not in the document regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Found: The document does not specify any quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) for the software's analytical capabilities (e.g., ejection fraction, cardiac output measurements). Consequently, there are no reported device performance metrics against such criteria. The "Summary of Studies" section only mentions evaluation against safety standards (IEC60601-1-4 and IEC 60601-2-33) for software and MR systems, not clinical performance.

2. Sample size used for the test set and data provenance:

• Not Found: There is no mention of a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's diagnostic or measurement accuracy. The studies mentioned are related to electrical and software safety, not clinical performance.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not Found: Since no clinical performance study or test set is described, there's no information about experts used to establish ground truth.

4. Adjudication method for the test set:

• Not Found: No clinical performance study, thus no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not Found: The document describes the GE Delta Software as an "analytical software tool" with "reproducible tools for the review and reporting of medical images," including various measurement tools. It states that "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis." However, it does not describe any MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without the AI assistance (as it's more of a quantitative measurement tool than a diagnostic AI).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Found: No standalone performance study, defined as "algorithm only without human-in-the-loop performance," is described. The device is presented as a tool to be used by a trained physician.

7. The type of ground truth used:

• Not Found: No clinical performance study means no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned.

8. The sample size for the training set:

• Not Found: There's no mention of a training set as this is not a study describing the development or validation of a machine learning algorithm in the way modern AI devices are presented. It's a software option providing measurement tools.

9. How the ground truth for the training set was established:

• Not Found: No training set, thus no ground truth establishment method.

In summary: The provided 510(k) pertains to the regulatory clearance of a software option for MRI that provides measurement and reporting tools, asserting its substantial equivalence to predicate devices (MEDIS Medical Imaging Systems FLOW and MASS). The evaluation focuses on safety standards (IEC60601-1-4, IEC 60601-2-33) for programmable electrical medical systems and MRI systems, rather than clinical performance metrics or studies involving patient data, ground truth, or reader performance.

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