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uWS-MI is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.

The Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time-activity curve.

The Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.

The Cardiac Analysis (ECTb™) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.

uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT or MR Images. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data or anatomical datasets, such as CT. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.

This Traditional 510(k) is to request modification for the cleared Picture archiving and communications system (uWS-MI) which have been cleared by FDA via K172998 on April 5, 2018.

The modifications performed on the uWS-MI (K172998) in this submission are due to the change of the basic application (Image Fusion) and the advance applications (Oncology and Dynamic Analysis).

The modifications of Brain Analysis application (NeuroQ™ -- cleared by FDA via K180077) is that it can make comparison between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.

The provided text describes a 510(k) submission for the uWS-MI software solution, which is intended for viewing, manipulating, and storing medical images, with specialized applications for Oncology, Dynamic Analysis, Brain Analysis (NeuroQ™), and Cardiac Analysis (ECTb™). The submission focuses on demonstrating substantial equivalence to a predicate device (uWS-MI, K172998) and several reference devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. However, the performance verification reports mentioned indicate that the device's algorithms were evaluated. The "Remark" column in the comparison tables serves as a qualitative acceptance criterion, stating whether a function is "Same," "New Function which will not impact safety and effectiveness," or "Modified function which will not impact safety and effectiveness."

Since no specific quantitative acceptance criteria
(e.g., minimum sensitivity, specificity, or image quality scores) are listed, the table below will summarize the functions and the qualitative assessment provided for the modified applications, which are the focus of this 510(k) submission.

Study Details:

The document states that no clinical studies were required. The performance evaluation was based on "Performance Verification" reports for specific algorithms.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify the sample sizes (number of images or cases) used for the test sets in the performance verification reports (e.g., for Lung Nodule, Lymph Nodule, Non-rigid Registration, Percentage Threshold Segmentation, PET-MR Auto Registration).
   • The data provenance (e.g., country of origin, retrospective or prospective nature) is not mentioned.

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

   • This information is not provided in the document.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided in the document, as no clinical studies are mentioned.

4. 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:

   • No MRMC study was done, as explicitly stated that "No clinical study was required." The device is primarily a post-processing software tool.

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

   • The document implies that standalone performance verification for specific algorithms (Lung Nodule and Lymph Nodule Segmentation, Non-rigid Registration, Percentage Threshold Segmentation, PET-MR Auto Registration) was conducted. However, detailed results (metrics, effect sizes, etc.) are not provided in this summary. It states "Performance Evaluation Report for..." these algorithms, suggesting the algorithms were evaluated on their own.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document does not specify the type of ground truth used for the performance verification of the algorithms.

7. The sample size for the training set:

   • This information is not provided in the document.

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

   • This information is not provided in the document.

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