(146 days)
Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print and distribute liver CT studies.
This software will assist the user by providing initial 3D segmentation, vessel analysis, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.
Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and measurement.
This software will assist the user by providing initial 3D segmentation, vessel analysis, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.
Key functionalities of the Hepatic VCAR include:
a. Lesion segmentation
b. Liver segmentation
c. Portal vein segmentation
d. Segment Separation by Portal Vein Branches
e. Virtual Scalpel feature
Hepatic VCAR is also made available as a standalone post processing application on the AW VolumeShare 5 workstation and the AW Server image processing platforms that host advanced image processing applications.
Here's an analysis of the provided text regarding the Hepatic VCAR device, focusing on its acceptance criteria and the study proving its performance.
Note: The provided document is a 510(k) summary and FDA letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific performance metrics and acceptance criteria as might be found in a full scientific publication or clinical trial report. As such, some information (especially quantitative acceptance criteria and detailed study results) is not explicitly present.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the device's acceptance criteria are framed in terms of substantial equivalence to its predicate device, Volume Viewer Plus (K041521). The summary asserts that Hepatic VCAR is "as safe, as effective, and performance is substantially equivalent to the predicate device."
Specific, quantitative acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity for lesion detection or segmentation) are not explicitly stated in this document. The "reported device performance" is primarily qualitative, asserting equivalence to the predicate and highlighting optimized algorithms.
| Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Safety and Effectiveness: "as safe, as effective" as predicate. | Hepatic VCAR is considered "as safe, as effective, and performance is substantially equivalent to the predicate device." |
| Functional Equivalence: Same fundamental scientific technology. | Employs the "same fundamental scientific technology" as the predicate device (Volume Viewer Plus). Utilizes "equivalent CT DICOM image data input requirements." Has "equivalent display, formatting, archiving and visualization technologies." |
| Algorithm Optimization & Functionality: Improved segmentation. | Optimizes the segmentation algorithms for lesion segmentation, liver segmentation, vessel (Portal Vein) segmentation, and liver lobe segmentation. Incorporates a "Virtual Scalpel feature" that takes advantage of existing visualization capabilities for virtual liver partition separation. "Thorough testing of these capabilities has not raised any safety or effectiveness issues." |
| Compliance: Adherence to relevant standards. | Complies with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. |
| Risk Mitigation: Development process quality assurance. | Quality assurance measures applied: Risk Analysis, Requirements Reviews, Design Reviews, Integration testing (System verification), Performance testing (Bench testing, verification), Safety testing (Verification). Substantial equivalence based on software documentation for a MODERATE level of concern device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in terms of number of cases or patients examined for clinical performance. The focus is on technical equivalence and functionality rather than a specific clinical validation study with a defined cohort.
The data provenance (e.g., country of origin, retrospective/prospective) for any internal testing is also not specified in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. Since detailed clinical performance metrics for a test set are not discussed, the establishment of ground truth by experts is not described.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for a test set, as a specific clinical performance test set with expert ground truth validation is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described or presented in this 510(k) summary. The document does not discuss human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as "assisting the user by providing initial 3D segmentation" and explicitly states "The user has the ability to adjust the contour and confirm the final segmentation." This indicates that the device is intended for human-in-the-loop use.
While "Performance testing (Bench testing, verification)" is mentioned, the summary does not detail a standalone algorithm-only performance study where the algorithm's output is evaluated without human interaction or adjustment in a clinical context. The claim of "optimized segmentation algorithms" implies some level of internal evaluation, but specifics are absent.
7. The Type of Ground Truth Used
Given the nature of the 510(k) summary and its focus on substantial equivalence based on technical aspects and functionality, a formal "ground truth" (such as pathology or long-term outcomes data) for clinical performance validation is not explicitly mentioned or described as being used in a reported study.
The closest to "ground truth" implied would be expert assessment of the "thorough testing of these capabilities" which "has not raised any safety or effectiveness issues," but the details of this assessment are not provided.
8. The Sample Size for the Training Set
The 510(k) summary does not disclose any information regarding the sample size used for training the algorithms within Hepatic VCAR.
9. How the Ground Truth for the Training Set Was Established
Similarly, the document does not provide details on how ground truth was established for any training data used in the development of Hepatic VCAR's algorithms.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.