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Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data.

MUV provides functionality that allows for creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.

MUV is intended to be used by trained healthcare professionals.

MUV can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of MUV on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Merge Universal Viewer (formerly known as IBM iConnect Access) is a software application that is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. Merge Universal Viewer provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.

Merge Universal Viewer was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/level, scroll, CINE, link series, and MPR. Additionally, the existing Merge Universal Viewer offers measurement and analysis tools such as line measurement, cross reference lines, rectangle, ellipse, perfect circle, freehand ROI, angle, Cobb angle, calibration, pixel value, plumb lines and cardiac calcium scoring.

A high-level overview of the modifications to the subject device being introduced as part of this 510(k) are as follows:

• Ability to display Mammography CAD SR
• Addition of the Volumetric SUV (Standard Uptake Value) to the measurement tools
• Addition of a DICOM Structured Report (SR) ingestion panel: The "Findings Panel":
  • Display of lung nodule detection and characteristics
  • Generalized lesion tracking (for CT and MR studies)
• Addition of cardiology measurement tools (for cardiac ultrasound studies)
• Miscellaneous updates such as:
  • Cybersecurity improvements to ensure full compliance with FDA's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance issued September 27, 2023.
  • The ability to display mammography images in full resolution using a keyboard shortcut
  • Bug fixes
• Labeling update, i.e., revised Indications for Use statement to reflect the new branding as well as to align with the current industry standards to consolidate the information

This FDA 510(k) clearance letter and summary for Merge Universal Viewer (MUV) K250301 primarily focuses on administrative and functional updates, and the "device" in question is medical image management and processing software (MUV). The provided document does not contain explicit acceptance criteria or details of a rigorous clinical study demonstrating the performance of the MUV in a diagnostic context against specific metrics like sensitivity, specificity, or reader agreement improvement.

The document states:

• "No clinical testing was performed as part of performance testing for MUV 9.0." (Page 9)
• The modifications are primarily a "branding update," "consolidation of information," and addition of features (e.g., display of Mammography CAD SR, Volumetric SUV, DICOM SR ingestion panel, cardiology measurement tools, cybersecurity improvements, full-resolution mammography display with keyboard shortcut, bug fixes). (Pages 7-8)
• The comparison is primarily focused on "technological characteristics" and "intended use" relative to predicate devices, and internal software verification and validation. (Page 8-9)

Therefore, based solely on the provided text, it is not possible to fill out the requested information regarding acceptance criteria and a study proving "the device meets the acceptance criteria" in terms of clinical diagnostic performance. The acceptance criteria described are internal to software development and regulatory compliance, not clinical diagnostic accuracy.

However, I will address what can be inferred or directly stated from the provided document regarding the requested categories:

Based on the provided FDA 510(k) Clearance Letter and Summary for Merge Universal Viewer (MUV) K250301, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are focused on software functionality, safety, and equivalence to predicate devices, rather than a clinical performance study with specific diagnostic accuracy metrics.

Here's a breakdown of the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified for any of the described tests (software verification, cybersecurity, usability, design validation). The document describes the types of tests performed on the software, not the number of specific cases or data points used.
• Data Provenance: Not specified. Given the nature of the tests (software verification, cybersecurity, usability, design validation), the "data" would be test results and logs generated during internal development and validation, rather than patient imaging data used in a clinical performance study. The document states "No clinical testing was performed." (Page 9)

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For software verification, cybersecurity, and design validation, these would likely be internal software engineers, quality assurance personnel, and subject matter experts on medical imaging systems.
  • For usability testing, "trained healthcare professionals" are mentioned as the intended users, but the specific qualifications of those who participated in usability testing are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. The described tests are about software functionality, usability, and security, not clinical diagnostic interpretation requiring adjudication of reader opinions.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "No clinical testing was performed as part of performance testing for MUV 9.0." (Page 9)
• Effect Size: Not applicable.

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

• Standalone Performance: No, a standalone performance study of an algorithm in a diagnostic context was not performed. The device is a viewer, not an AI diagnostic algorithm meant to be used standalone. It displays data, including "Mammography CAD SR" and "DICOM Structured Report (SR) ingestion panel," which implies it can display outputs from other algorithms, but it is not itself an algorithm generating diagnostic interpretations.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the software validation and verification, the "ground truth" would be the expected functionality, design specifications, and security requirements laid out by the developers and in regulatory guidance. It is not clinical ground truth (e.g., pathology, expert consensus, outcomes data) as no clinical performance study was conducted.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. MUV is an image viewer and management system, not a machine learning model that undergoes a "training" phase with a dataset in the typical sense of AI/ML development for diagnostic tasks.

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

• Training Set Ground Truth Establishment: Not applicable, as MUV is not an AI/ML model for diagnostic training.

In summary, the provided FDA document focuses on the safety and effectiveness of the Merge Universal Viewer 9.0 primarily through demonstrating:

• Its functional integrity through software verification and design validation.
• Its cybersecurity resilience.
• Its usability for trained healthcare professionals.
• Its substantial equivalence to previously cleared predicate devices for image management and viewing, including the display of information from other diagnostic tools (like CAD SR or structured reports), but not its own diagnostic performance or improvement in human reader accuracy.

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