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510(k) Data Aggregation
(260 days)
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: Xray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic decision resides with the doctors and/or the medical staff in their respective area of responsibility.
Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complicable diagnostic requirements and the state-of-the-art.
Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.
Visage Ease Pro has a graphical user interface which is optimized for mobile devices with a touch screen. The app allows searching for studies and viewing images and reports. The user may zoom and pan images, adjust the window level, browse through a stack of images or play a cine animation. Patient and image information is displayed as viewer text. The app supports voice memos, image attachments and push notifications.
Visage Ease Pro is designed as a thin client in a single module and allows to remotely access the images on a Visage 7 server. The communication between the mobile client and the server is encrypted. The user must authenticate himself with username and password. A connection can only be established, if the user has the appropriate permissions for using the mobile client. These permissions are configurable on the Visage 7 server.
The provided document does not contain the specific acceptance criteria and detailed study results that would typically be found in a performance study report. This document is a 510(k) summary for the Visage Ease Pro, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative acceptance criteria and results against those criteria.
However, based on the information available, I can extract and infer some details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like sensitivity, specificity, or reader agreement percentages. Instead, the "clinical validation" described is qualitative and focused on functional equivalence.
| Acceptance Criteria (Inferred from "Summary of testing") | Reported Device Performance |
|---|---|
| Primary operating functions are equivalent to predicate devices for clinical use cases: | Clinically validated as equivalent to predicate devices Visage 7® and Mobile MIM™ |
| Loading of images | Functionality is equivalent |
| Selecting a series of images | Functionality is equivalent |
| Adjusting the window level | Functionality is equivalent |
| Zooming and panning an image | Functionality is equivalent |
| Browsing through a stack of images | Functionality is equivalent |
| Playing cine animations | Functionality is equivalent |
| No new clinical functionality compared to Visage 7 | Confirmed |
| Identical behavior and leading to same diagnosis as predicate devices | Confirmed by clinical validation |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "The data sets for the modalities CT, CR, DX, MRI, PET, SPECT, US, and XA are viewed with the predicate devices and Visage Ease Pro." This implies a set of diverse radiological images, but the exact number is not provided.
- Data Provenance: Not explicitly stated.
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)
Not explicitly stated. The "clinical validation" implies expert review, but the number and qualifications of the experts or how ground truth was established are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly stated. Given the qualitative nature of the validation described, it's unlikely a formal adjudication method for ground truth was applied in a traditional sense for quantitative performance metrics. The validation seems to involve expert comparison of functionalities.
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
No such study was mentioned. The device is a mobile viewing client and not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study regarding "human readers improve with AI" would not be applicable here. The validation focused on functional equivalence to other viewing platforms.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not entirely applicable as the Visage Ease Pro is a mobile client for viewing images, not an algorithm that performs standalone diagnostic functions. Its performance is tied to its ability to display images accurately and provide viewing functionalities comparable to predicate devices. The "standalone" performance, in this context, would be the consistent and correct execution of its stated functionalities. The document states it was "clinically validated" for its primary operating functions, which is a form of standalone functional verification.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. Given the device's function as an image viewer, the "ground truth" for its functional validation would likely be the correctness and completeness of image display and manipulation features compared to the known characteristics of the images and the performance of the predicate devices. This would involve technical specifications and potentially expert-confirmed visual accuracy.
8. The sample size for the training set
This device appears to be a software client for viewing images rather than a machine learning algorithm that requires a training set in the typical sense. Therefore, "training set" is not applicable.
9. How the ground truth for the training set was established
Not applicable (see point 8).
In Summary:
The provided document is a 510(k) summary for a medical image viewing client. Its "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to existing predicate devices in terms of functionality for viewing radiological images. It does not contain quantitative performance metrics, detailed study designs (like MRMC), or information typically associated with AI/CAD systems that require extensive annotated datasets and statistical performance evaluations. The clinical validation appears to be a qualitative assessment of the device's ability to perform its viewing functions similarly to already cleared devices.
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