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MiPACS HTML5 Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MIPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.g. Google Chrome. Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

MiPACS HTML5 is a medical software with a Moderate level of concern.

MiPACS HTML5 Web Viewer uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access the device and RIS systems. Whether on-site or from another location, physicians and trained professionals can manage, edit, view and move diagnostic exams quickly and efficiently. As part of the MiPACS HTML5 Web Viewer support, Medicor Imaging, performs virtually all the system maintenance.

The MiPACS HTML5 Web Viewer is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

• . To store and retrieve various kinds of DICOM Objects such as:
  • -Images from multiple modalities,
  • -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
  • -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
  • -Structured Reports [SR].

The MiPACS HTML5 Web Viewer, is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

The provided document is a 510(k) summary for the MiPACS HTML5 Web Viewer, which is a medical image management and processing system. The summary describes the device, its intended use, and a comparison to a predicate device, but it explicitly states that clinical testing was not necessary to show substantial equivalence. Therefore, there is no study provided that proves the device meets specific acceptance criteria in a clinical context with human readers or standalone algorithm performance.

The document mainly focuses on nonclinical testing and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a specific table of quantitative acceptance criteria for image viewing performance or associated reported device performance metrics like sensitivity, specificity, or AUC, as these would typically come from clinical studies. The "acceptance criteria" mentioned refer to predetermined testing criteria met during nonclinical validation testing.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable for a clinical test set. The document refers to "validation testing" which is nonclinical. The sample size of test cases (e.g., DICOM objects, images) used in this nonclinical testing is not specified.
• Data Provenance: Not applicable for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical ground truth was established by experts as clinical testing was not performed.

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, and the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states, "Clinical testing is not necessary to show substantial equivalence for the subject device." The device is a "Medical Image Management and Processing System" (viewer), not an AI-powered diagnostic aid that would typically undergo an MRMC study to compare reader performance with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, not in the sense of a diagnostic algorithm. The device is a viewer. "Standalone performance" in this context refers to its functionality as a software system in handling and displaying medical images, which was assessed through nonclinical validation testing. The summary states: "Based on the performance as documented in the Validation Testing, MiPACS HTML5 Web Viewer was found to have a safe and effectiveness profile that is similar to the predicate device."

7. The type of ground truth used:

For the nonclinical testing, the "ground truth" would likely be the expected functional behavior and output of the software according to its design specifications and compliance with DICOM and other relevant standards. For example, if a DICOM image is loaded, the ground truth for its display would be that it renders correctly, with accurate window/level manipulations, zoom, measurements, etc., as per DICOM standards and the device's functional design. This is a form of design specification compliance.

8. The sample size for the training set:

Not applicable. This device is a medical image viewer and does not involve a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

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