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

The PET/CT 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 PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.

The PET/CT 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.

The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion 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 and PET/CT patient studies. 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, such as PET as well as 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.

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the format requested. However, based on the scattered information, I can infer some points and explicitly state what is missing.

The device is uWS-MI, a software solution for viewing, manipulation, and storage of medical images, with specific applications for PET/CT Oncology, PET/CT Dynamic Analysis, PET/CT Brain Analysis (NeuroQ™), and PET/CT Cardiac Analysis (ECTb™).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed quantitative results.

Here's an attempt to extract and synthesize the information based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). However, it mentions "Performance evaluation Report for PET/CT Oncology and Image Fusion" as part of Performance Verification. Details about this report, including the data used, are not provided. Given the nature of a 510(k) summary, the data often comes from internal testing designed to show equivalence, rather than large-scale clinical trials.

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

This information is not provided in the document. Ground truth establishment details are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not specifically mentioned or detailed. The document focuses on demonstrating substantial equivalence based on features and software verification, and states "No clinical study was required." for general device clearance. The performance of specific applications (NeuroQ™ and ECTb™) leverages their prior clearances, implying that their functionalities, rather than a new comparative effectiveness study of the full uWS-MI system, were reviewed.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device is described as "stand-alone software," and its primary verification listed is "Software Verification and Validation." This suggests that the performance verification would have evaluated the algorithm's output independently, as a standalone system. However, the exact metrics and results of this standalone performance are not explicitly provided beyond the statement of functional equivalence to predicate/reference devices.

7. Type of Ground Truth Used

The type of ground truth used for specific performance evaluations is not explicitly stated. However, considering the device's function as an image post-processing and analysis tool, the ground truth would typically involve:

• Expert consensus or expert readings: For evaluating the accuracy of image analysis, measurements, or lesion segmentation outputs.
• Pathology or clinical outcomes data: For validating the diagnostic accuracy of features, particularly for oncology applications, though "no clinical study was required" suggests this was not the primary method for this 510(k).
• Phantom or synthetic data: For testing algorithm robustness and accuracy in controlled environments.

Since the PET/CT Brain Analysis (NeuroQ™) and PET/CT Cardiac Analysis (ECTb™) applications were cleared previously, their ground truth would have been established during their initial clearances, likely involving expert-derived truth based on clinical images or phantoms.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of any training set. As a 510(k) for a software device, the focus is often on functional equivalence and verification/validation, rather than detailing the machine learning model training process if such models are embedded.

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

This information is not provided in the document.

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