(54 days)
ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound.
ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.
ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.
ViewPoint 6 is not intended to operate medical devices in surgery related procedures.
ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements.
Viewpoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.
ViewPoint 6 supports both a single workstation and a client/browser - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality.
ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network.
The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing.
This product does not control or alter any of the medical devices providing data across the hospital network.
The provided text is a 510(k) Summary for a medical device called "ViewPoint 6." This type of document focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed primary study results with acceptance criteria and specific performance metrics as would be found in a clinical study report. It primarily outlines the scope of V&V activities and voluntary standards adhered to.
Based on the provided text, the following information can be extracted regarding the device performance and acceptance criteria:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in terms of clinical accuracy (e.g., sensitivity, specificity). Instead, it states that:
"Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met."
This implies that the acceptance criteria are tied to the fulfillment of software and user requirements, which are assessed through various testing activities, but the specific numerical performance metrics are not detailed in this summary. The general statement about "Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements" suggests that performance acceptance is related to system specifications rather than clinical efficacy metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify any sample sizes for a clinical test set, nor does it provide data provenance (e.g., country of origin, retrospective or prospective nature). The V&V activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Performance testing, Safety testing) are typically software engineering and system-level tests and do not involve a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy.
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)
No clinical test set is described, and therefore, there is no information about the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No clinical test set is described, so no adjudication method is mentioned.
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
The document states:
"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."
This explicitly indicates that no MRMC comparative effectiveness study, or any clinical study, was conducted or deemed necessary for this 510(k) submission. Therefore, there is no information about AI assistance or its effect size on human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data." The indications for use state it "is not intended to be used as an automated diagnosis system." This confirms it's a tool to assist clinicians, not a standalone diagnostic algorithm. No standalone algorithmic performance study was conducted or mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As no clinical studies were performed for diagnostic accuracy, no specific ground truth type (expert consensus, pathology, outcomes data, etc.) is mentioned. The V&V activities focused on software and system requirements.
8. The sample size for the training set
The document does not refer to any AI/ML components that would require a training set. Therefore, no training set sample size is provided.
9. How the ground truth for the training set was established
Since no training set is mentioned for AI/ML, there is no information on how its ground truth would be established.
In summary:
This 510(k) submission for ViewPoint 6 primarily relies on demonstrating substantial equivalence to a predicate device (ViewPoint 6 v6.12 K203677) through software validation and verification activities, adherence to voluntary standards, and a comparison of technological characteristics. It explicitly states that clinical studies were not required because the changes from the predicate device were not deemed to have a significant impact on clinical performance. Therefore, detailed information regarding clinical performance acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance metrics is not present in this document.
§ 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).