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The MeVis LiverAnalyzer / LiverViewer Software™ device is intended for preoperative planning in liver surgery. The device is used to analyze data and to display image analysis and risk analysis results for the preoperative planning in liver surgery, e.g. organ segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections splitting the liver or to calculate safetymargins around lesions identifying affected vascular branches and vascular territories supplied or drained by these branches.

MeVis LiverAnalyser / LiverViewer Software™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format. The MeVis-LiverAnalyser is used to analyze data for preoperative planning in liver surgery. The MeVis-LiverAnalyzer contains dedicated methods for organ segmentation, tumor segmentation, and segmentation of intrahepatic vasculature as well as for the approximation of vascular territories. While using the MeVis-LiverAnalyser a number of masks are produced to merge voxels into sets. Each of this set is meant to represent a specific anatomical entity. All volumes calculated by the MeVis-LiverAnalyzer are given directly by the number of voxels in one of these sets multiplied by the voxel volume. No direct measure of anatomical entities is performed.

This FDA 510(k) summary for the MeVis LiverAnalyser / LiverViewer Software™ discusses the device's intended use and substantial equivalence to predicate devices, but does not provide a study demonstrating the device meets specific acceptance criteria.

The document is not a study report. It is a regulatory submission that asserts the device's safety and effectiveness are substantially equivalent to previously cleared devices. It states that "The 510 (k) Pre-Market Notification for MeVis LiverAnalyser / LiverViewer Software™ device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." However, it does not disclose the details of the "information and data" that would constitute a study proving acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text.

Based on the provided text, I can extract the following limited information:

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

• Information not available. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present a table of device performance against such criteria. It generally states that the device is "substantially equivalent" to predicate devices for its intended use.

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

• Information not available. No details about test set sample size or data provenance are mentioned.

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)

• Information not available. This is not detailed in the provided regulatory summary. The summary mentions that "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed," suggesting human oversight, but doesn't specify how ground truth for any potential validation would be established or by whom.

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

• Information not available.

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

• Information not available. The document states the software "assists surgeons when doing preoperative planning" and that a "physician... interprets images and information." However, it does not provide details of any MRMC study or the effect size of AI assistance on human reader performance.

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

• The device's description implies it is an aid for human users: "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed." This suggests it's not intended for standalone use without human interpretation. However, no specific standalone performance study details are provided.

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

• Information not available.

8. The sample size for the training set

• Information not available.

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

• Information not available.

Summary of what is available from the document:

• Device Name: MeVis LiverAnalyser / LiverViewer Software™
• Intended Use: Preoperative planning in liver surgery, including organ segmentation, tumor segmentation, segmentation of intrahepatic vessels, approximation of vascular territories, interactive definition of virtual resections, and calculation of safety margins around lesions.
• Modality: Imports medical images (CT, MRI) in DICOM format.
• User: Trained professionals, including physicians, nurses, and technicians.
• Regulatory Conclusion: FDA determined substantial equivalence to predicate devices (K022692, K040852) based on "adequate information and data," but the specifics of that data are not disclosed in this summary.
• Nature of the device: Software is a "PC-based software application" and "does not contact the patient, nor does it control any life sustaining devices." It is an assistive tool for human interpretation.

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