(15 days)
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements.
It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data.
CubeVue provides a list of patient scans that have been sent to the its image database through its DICOM interface or imported locally by the user can browse, search, and sort the patient list to select a patient and open his or her image data.
The main screen displays a 3D rendering of the image in addition to axial, sagittal, and coronal slices. In the slices, the user can navigate through the volume by paging and rotating. The user can also adjust the window level, zoom, and pan of the 2D slices. In the 3D volume, the user can rotate the volume, cut through a plane, and change the displayed tissue density threshold and rendering style.
The user can make measurements on the image including distances, angles, and density values.
The user can export patient data to a file or media, with the option to anonymize patient demographic information. It supports DICOM and JPEG for image communication.
The provided text is a 510(k) summary for the CubeVue device, which is a Picture Archiving Communications System (PACS). The submission aims to demonstrate substantial equivalence to the predicate device, Osirix MD.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative manner (e.g., target accuracy percentages or specific error rates) for the CubeVue device itself. Instead, the performance testing focuses on demonstrating that CubeVue's functionalities are equivalent to the predicate device, Osirix MD, for the subset of applications CubeVue supports (extremity Cone Beam CT and extremity X-Ray data).
The "Functionality" table provided in the 510(k) summary lists features and directly states whether both CubeVue and Osirix MD possess them. The "Reported Device Performance" is implied by the "Yes" entries in for CubeVue, indicating it meets the described functionalities.
| Functionality (Acceptance Criteria representing equivalence to predicate) | CurveBeam CubeVue (Reported Device Performance) | Osirix MD (Predicate Performance) |
|---|---|---|
| The device shall have the ability to view DICOM tags | Yes | Yes |
| The device shall have the ability to import/export DICOM data to another AE or export media | Yes | Yes |
| The device shall have the ability to view dose reports | Yes | Yes |
| The device shall have the ability to export images as JPEG | Yes | Yes |
| The device shall have the ability to view 2 series, side by side | Yes | Yes |
| The device shall have the ability to view 3D CT volumes using multi-planar-reformatting (MPR) (axial, sagittal, coronal) | Yes | Yes |
| The device shall have the ability to view 3D CT volumes in MPR using an arbitrary curve | Yes | Yes |
| The device shall have the ability to adjust the rotation (X/Y/Z) of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to cut 3D CT volumes at arbitrary angles | Yes | Yes |
| The device shall have the ability to adjust Window/Level of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust the zoom of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust the center (move, pan) of 3D CT volumes. | Yes | Yes |
| The device shall display orientation markers [right(R), left(L), anterior(A), posterior(P), head(H), and feet(F)] on 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust slice thickness on all MPR views. | Yes | Yes |
| The device shall have the ability to render both maximum-intensity-projection (MIP) or radiographic views. | Yes | Yes |
| The device shall have the ability to display Hounsfield Unit (HU) measurements with mean, standard deviation, and area/volume on 3D CT volumes. | Yes | Yes |
| The device shall have the ability to measure and display length and angles on 3D CT volumes. | Yes | Yes |
| The device shall provide surface and volume rendering of the bone, soft tissue and soft tissue with transparency showing the bone | Yes | Yes |
| The device shall have the following 3D volume render view capabilities crop a 3D volume interactively | Yes | Yes |
| The device shall have the following 3D volume render view capabilities create STL (Stereolithography) file format based on desired HU value, with desired name, to be used in third party software. | Yes | Yes |
| The device shall have the following 3D volume render view capabilities segmentation of bones or user-defined regions | Yes | Yes |
| HIPPA compliance, hide patient list, hide patient demographics, anonymize patient information | Yes | Yes |
| The device shall conform to the following consensus standards: DICOM and JPEG. | Yes | Yes |
| For prescription use | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Verification and Validation testing" and "Testing Results" but does not specify the sample size of image data used for testing. It also does not explicitly state 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 Qualifications of Those Experts:
The document does not describe the establishment of a "ground truth" for the test set or the involvement of experts for this purpose. The testing primarily involved software validation/verification against system requirements and comparison of functionalities to the predicate device.
4. Adjudication Method for the Test Set:
No adjudication method is described as the testing was focused on software functionality rather than diagnostic performance against a ground truth assessed by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement:
No MRMC comparative effectiveness study is mentioned. This type of study is typically performed for AI/CADe devices that directly assist in diagnostic tasks, which is not the primary claim of this PACS system (CubeVue's role is display and manipulation of images for diagnosis and planning, not direct AI-based interpretation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The testing appears to be "standalone" in the sense that it evaluates the software's functionality independently. However, CubeVue is a PACS accessory to Cone Beam CT devices, and its intended use is to aid users (humans) in diagnosis and treatment planning. The software itself is not making diagnostic decisions without human oversight. The testing described is functional testing of the software.
7. The Type of Ground Truth Used:
As noted above, no specific "ground truth" (like expert consensus, pathology, or outcomes data) is mentioned as being used for performance evaluation in the context of diagnostic accuracy. The ground truth for the functional testing would be the expected behavior of the software based on its design specifications and standard requirements (DICOM, JPEG).
8. The Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set in the conventional sense for learning patterns from data. It is a PACS system for displaying and manipulating images. Therefore, the concept of a "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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).