(31 days)
4D MV Assessment is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
4D MV Assessment reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for subsequent 3D/4D tomographic reconstruction and rendering. It is intended as a general purpose digital 3D/4D ultrasound image processing tool for cardiology.
4D MV-Assessment 2.0 is intended as software to analyze pathologies related to the mitral valve.
4D MV-Assessment® is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 4D MV-Assessment is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images and Color Doppler images. The data is acquired by ultrasound machines that are able to store compatible 3D/4D datasets. The digital 3D/4D data can be used for comprehensive morphological and functional assessment of the mitral valve.
4D MV-Assessment is compatible with different Tom Tec Image-ArenaTM platforms, their derivatives or any other platform that provides and supports the Generic CAP Interface. Platforms enhance the workflow by providing the database, import, export and other functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes.
4D MV-Assessment is designed for 2-, 3- and 4-dimensional morphological and functional analysis of mitral valves (MV). Based on an easy and intuitive workflow the application package generates models of anatomical structures such as MV annulus, leaflet and the closure line. Automatically derived parameters allow quantification of pre- and post-operative valvular function and comparison of morphology.
4D MV-Assessment improves the presentation of anatomy and findings to surgeons and cardiologists and visualizes the complex morphology and dynamics of the mitral valve.
The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.
The provided text from the 510(k) summary for the "4D MV-Assessment 2.0" device does not contain detailed information regarding specific acceptance criteria, study methodologies, or performance results in the way requested by the prompt.
The document states:
- "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 subject device is as safe as effective, and performs as well as the predicate devices."
- "Test results support the conclusion, that the subject device is as safe as effective, and performs as well as or better than the predicate devices."
However, it explicitly refers to "Chapter 16: Software, Verification and Validation Documentation" for details, which is not included in the provided text. Therefore, I cannot extract the specific information requested in the table and detailed study aspects.
Based only on the provided text, I can state that:
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Acceptance Criteria and Reported Device Performance: This information is not provided in the given summary. The document generally states that the device was found to be "as safe as effective, and performs as well as or better than the predicate devices" based on non-clinical and clinical performance data, but specific metrics or criteria are not detailed.
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Sample size for the test set and data provenance: Not mentioned.
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Number of experts used to establish ground truth and qualifications: Not mentioned.
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Adjudication method: Not mentioned.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on the device's standalone capabilities and its comparison to predicate devices, but no human-in-the-loop study with effect sizes is described.
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Standalone (algorithm-only) performance: The device is described as "software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images and Color Doppler images" and performs "3- and 4-dimensional morphological and functional analysis of mitral valves." This implies a standalone algorithmic function, but specific performance metrics for this standalone mode are not provided in the summary.
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Type of ground truth used: Not explicitly stated. The document refers to "clinical test results" and "morphological and functional assessment," which implies comparison against clinical observations or established diagnostic criteria, but the precise nature of the ground truth (e.g., expert consensus, pathology, outcome data) is not specified.
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Sample size for the training set: Not mentioned.
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How the ground truth for the training set was established: Not mentioned.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).