(57 days)
NubeX, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.
NubeX is a based on the predicated Picture Archiving and Communication system (PACS) device (INFINITT ULite, K163290).
NubeX is for displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Among part of image processing, there are different functions than predicated device (INFINITT ULite, K163290).
In NubeX, provide image stacking function and 3D cursor function. In case of stacking, after putting the mouse point on an image, you can use the mouse wheel to view the previous or next image of the current one in the series. Stacking shows images within the series. Thus, although the last image currently shows up and the mouse wheel moves down, the last image does not get changed.
In case of 3D cursor, after turning on the "3D Cursor" button and selecting an image or stack window, if you use the mouse left button to click and drag on the image, you can see the "X" mark and move the mark to any direction. At that time, you can see the images which are on the mark point in the 3D space. For example, when you click and drag on a sagittal image, you can see the images axial images that are on the mark point in the 3D space.
Other than that, the functions basically provided as PACS are the same as those of predicated devices and the additional PACS features don't present any risk to device safety.
The NubeX device is a Picture Archiving and Communication System (PACS) intended for displaying, communicating, storing, and processing medical images and data. It is substantially equivalent to the predicate device, INFINITT ULite (K163290).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a PACS system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical performance metrics typical of AI/CADe devices. As such, explicit quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for diagnostic tasks are not present in this document. The "performance" discussed primarily relates to software functionality and safety, asserting that the device performs as intended and does not introduce new risks.
| Acceptance Criteria (Explicitly Stated in the document) | Reported Device Performance |
|---|---|
| Software Verification and Validation | Complies with IEC 62304:2015 |
| Cybersecurity Verification and Validation | Complies with FDA guidance on Cybersecurity in Medical Devices |
| Function Test Performance | Passed all in-house pre-determined testing criteria without significant failures. Performs all required actions according to functional requirements with no errors impacting safety or efficacy. |
2. Sample Size and Data Provenance
The document does not specify a sample size for a test set (e.g., number of images, patients) or the data provenance (e.g., country of origin, retrospective/prospective). This is because the device, NubeX, is a PACS viewer and not an AI or diagnostic algorithm that would typically require such a clinical test set to evaluate its diagnostic performance. The testing described is primarily software functional testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention using experts to establish ground truth for a test set. This type of evaluation is not applicable to a PACS system that primarily handles image display and management, rather than providing a diagnostic interpretation or algorithmic output that needs to be compared against expert consensus or pathological findings.
4. Adjudication Method
Not applicable. No diagnostic test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance, as NubeX is a PACS system and does not provide AI-driven diagnostic assistance.
6. Standalone Performance Study
Not applicable. The device's performance is described in terms of its functional capabilities as a PACS system, not as a standalone diagnostic algorithm. The non-clinical performance data references "function tests" and "software verification and validation," which are evaluations of the system's operational integrity rather than diagnostic accuracy.
7. Type of Ground Truth Used
No clinical ground truth (such as expert consensus, pathology, or outcomes data) was used in the context of diagnostic performance evaluation, as the device is not an AI diagnostic algorithm. The "ground truth" for the non-clinical performance data would be the functional specifications and requirements of the software itself.
8. Sample Size for the Training Set
Not applicable. NubeX is a PACS system, not an AI or machine learning algorithm that requires a training set of medical images for model development.
9. How Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model, there is no ground truth establishment process described for a training set.
§ 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).