Search Results

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 has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.

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 clientserver 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.

The provided text contains information about a 510(k) submission for the ViewPoint 6 device, which is a Picture Archiving and Communications System (PACS). However, it explicitly states, "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. It focuses on non-clinical tests (compliance with standards, quality assurance measures).

Here's what can be extracted based on the prompt's requirements, highlighting the lack of relevant clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there are no reported acceptance criteria or device performance metrics from a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used as clinical studies were not required.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not performed as clinical studies were not required.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) was Done

Not applicable. The device is a PACS system for diagnostic interpretation and reporting, not an automated diagnosis system. The submission explicitly states: "ViewPoint 6 is not intended to be used as an automated diagnosis system." Therefore, a standalone algorithm performance study is not relevant in the context of this device.

7. The Type of Ground Truth Used

Not applicable. No clinical test set requiring ground truth was used.

8. The Sample Size for the Training Set

Not applicable. The device is a PACS software, not an AI/ML diagnostic algorithm that would typically involve a "training set" for model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there is no mention of a training set or associated ground truth.

Summary of Non-Clinical Tests and Quality Assurance (as provided in the document):

The device complies with the following voluntary standards:

• IEC 62366-1:2015 Medical devices Application of usability engineering to medical devices
• IEC 62304:2006, Medical device software Software life cycle process
• NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
• ISO 14971:2012 Medical Devices Application of risk management to medical devices

Quality assurance measures applied to the development of the system include:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final Acceptance Testing (Design Validation and Service Validation)
• Performance testing (Verification)
• Safety testing (Verification)

Ask a specific question about this device