(13 days)
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:
Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.
The ViTALConnect system is a medical diagnostic device that allows the processing, review. analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The ViTALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ViTALConnect system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- . Retrieve image data over the network via DICOM
- Display images that are automatically adapted to exam type via dedicated protocols .
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology .
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an Intranet . Web server or export views to another DICOM device
- . Retrieve reports that are archived on a Web server
The provided text is a 510(k) summary for the VITALConnect™ 4.0 - Medical Image Processing Software. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving those criteria are met.
Here’s a breakdown of what can be answered based on the provided text, and what information is missing:
Acceptance Criteria and Device Performance (Missing Information)
The document does not explicitly state any quantitative acceptance criteria for the device's performance, nor does it provide a table of reported device performance against such criteria. The focus of this 510(k) summary is on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with metrics.
Study Details (Incomplete Information)
The document mentions "Summary of Studies" but provides very high-level descriptions, not a detailed study report.
- Sample size used for the test set and the data provenance: Not specified. The document states "Software Beta testing/validation will be successfully completed prior to release," but it doesn't mention the size or origin of the data used for this testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
- 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: Not specified. The document focuses on the software as a processing and visualization tool, not an AI-assisted diagnostic aid that would typically warrant an MRMC study with improvement effect sizes.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified. While the software processes images, the descriptions always imply a clinician in the loop (e.g., "aid clinicians in the study and analysis," "clinician retains the ultimate responsibility").
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- The sample size for the training set: Not applicable/Not specified. The document describes software that processes and analyzes pre-acquired images. It doesn't describe a machine-learning model that undergoes "training" in the typical sense with a separate training set.
- How the ground truth for the training set was established: Not applicable/Not specified.
Summary of Available Information from the Text:
| Information Category | Details from Provided Text |
|---|---|
| Acceptance Criteria & Device Performance | Not explicitly stated. The document is a 510(k) summary focusing on substantial equivalence to a predicate device (VITALConnect System - K040876). It states: "The ViTALConnect 4.0 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." This implies internal acceptance criteria for software quality and functionality were met, but these are not disclosed. |
| Sample size (Test Set) | Not specified. "Software Beta testing/validation will be successfully completed prior to release." |
| Data Provenance (Test Set) | Not specified. |
| Number of Experts / Qualifications (Test Set) | Not specified. |
| Adjudication Method (Test Set) | Not specified. |
| MRMC Comparative Effectiveness Study | No indication of an MRMC study. The device is described as a processing, review, analysis, and communication system. Its features aid clinicians but there is no mention of comparative effectiveness or "AI vs without AI assistance" which would suggest an MRMC study. The text primarily describes the device's functionality rather than a change in diagnostic accuracy for human readers. |
| Standalone Performance Study | Not explicitly stated as a "standalone" study in the sense of algorithm-only diagnostic performance. The entire description, particularly for features like Advanced Vessel Analysis and Pet Visualization, emphasizes the system aiding clinicians, with the clinician retaining responsibility for diagnosis. This suggests a human-in-the-loop context. |
| Type of Ground Truth Used | Not specified. |
| Sample Size (Training Set) | Not applicable/Not specified. The document describes a general medical image processing software, not a machine learning or AI algorithm that would typically have a "training set" for model development. The "studies" mentioned refer to general software development, testing, and validation according to written procedures, and risk management. |
| Ground Truth Establishment (Training Set) | Not applicable/Not specified. As there's no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not applicable here. The ground truth for software validation would typically involve comparing processed output against expected results or human expert evaluation for accuracy of measurements and visualizations, but these details are not provided in this summary. |
Conclusion from the provided text:
This 510(k) summary focuses on demonstrating that the VITALConnect™ 4.0 system is substantially equivalent to its predicate device (VITALConnect System - K040876) based on similar intended uses and technological characteristics. It mentions that the software was "designed, developed, tested, and validated according to written procedures" and would undergo "integration testing/verification testing" and "Software Beta testing/validation." However, it does not provide the detailed performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement that your request specifically asks for. This type of detailed performance data is often found in the full 510(k) submission or supplementary documents, not typically in the summary provided.
§ 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).