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Lightning Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL) and other healthcare imaging applications.

Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, requlatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes.

Lightning Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari, and Windows. Lightning Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography.

Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality: to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists.

Lightning Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. Lightning Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Lightning Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports.

Lightning Viewer is a web-based DICOM medical image viewer that allows for diagnostic viewing, measuring, manipulating, and annotation of radiological series and images. The Lightning Viewer is part of a server, providing healthcare professionals with a comprehensive tool for accessing and interacting with medical images. Key features and functions of the Medweb Lightning Viewer include:

• A web browser-based interface for easy access without client software installation ●
• Support for multiple imaging modalities including CR/DR/XR, CT, MR, US/US Echo, MG (Mammo), FL (Fluoro), VL (visual light), NM (Nuclear medicine), PET
• . Advanced image manipulation tools such as window/level adjustment, zooming, panning, and image rotation
• . Measurement and annotation capabilities including length, angle, area, and freehand ROI tools
• Specialized tools for specific imaging modalities, such as for mammography tools and spine labeling
• . MPR (Multiplanar Reconstruction) mode with crosshairs tool for 3D visualization and MIP (Maximum Intensity Projection)
• . Synchronized scrolling across series and studies for efficient comparison
• Customizable layouts and hanging protocols for various study types
• DICOM-compliant image viewing and data management .

The Medweb Lightning Viewer consists of a user-friendly workspace with a customizable toolbar, providing quick access to commonly used tools. The viewer supports various layout options, including side-by-side comparison of series and prior studies. Users can easily navigate through image stacks, adjust window/level settings, and apply advanced visualization techniques like MPR.

Medweb Lightning Viewer is designed to integrate seamlessly with existing PACS installations. It allows authorized users to access patient studies from multiple sources, facilitating efficient workflow for radiologists, physicians, and other healthcare professionals.

Lightning Viewer provides a comprehensive set of tools for image review and analysis. It supports various image formats and modalities, making it a versatile solution for healthcare facilities of all sizes.

The system employs user authentication and access controls to ensure that only authorized personnel can access sensitive patient information. This makes it suitable for use both within healthcare facilities and for remote access by referring physicians or specialists, promoting efficient telemedicine and teleradiology practices.

The provided document, a 510(k) Summary for the Lightning Viewer, describes the device's acceptance criteria and the study that proves it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the Lightning Viewer's performance was evaluated through "Software Verification and Validation Testing" and "Non-Clinical Performance Testing". The acceptance criteria are implicitly that the device performs equivalently to the predicate device and accurately calculates measurements.

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

• Sample Size for Test Set: Not explicitly stated for either the software verification/validation or the phantom study. The document only mentions "a dataset with known voxel dimensions" for the phantom study.
• Data Provenance: Not explicitly stated. Given the nature of the tests (software verification/validation, phantom study), the data would likely be internally generated and controlled rather than from external patient sources or specific countries. It's a non-clinical evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For a phantom study, ground truth is typically established by the known physical properties of the phantom and the measurements taken from it, rather than expert interpretation. For software verification/validation, ground truth is typically against predefined functional specifications and requirements.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or not specified. Given the nature of the studies (software verification/validation and phantom study), expert adjudication in the medical sense (e.g., 2+1, 3+1 for clinical endpoints) is not described. Ground truth for these types of studies is usually based on predefined specifications or known physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable as no MRMC study was performed. The device is a medical image management and processing system, not an AI-assisted diagnostic tool for human readers in the context of improving their performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The document implies that standalone performance was assessed for measurement accuracy in the phantom study. The "device accurately calculates distance and angle measurements" without mention of human intervention in the calculation process. However, the primary purpose of the device is a viewer that facilitates human review, not an autonomous diagnostic algorithm. The software verification and validation would also evaluate the standalone functionality of the viewer.

7. The Type of Ground Truth Used:

• Software Verification and Validation: Ground truth was established against predefined "design requirements" and "intended use and user needs." This implies a set of functional and performance specifications.
• Non-Clinical Performance Testing (Phantom Study): Ground truth was established by a "dataset with known voxel dimensions" which allows for precise calculation of true distances and angles against which the device's measurements are compared.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. The Lightning Viewer is a DICOM viewer and image manipulation system, not a machine learning or AI-driven diagnostic algorithm that requires a training set in the conventional sense. Its functionality is based on established image processing algorithms and display standards.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.

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