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uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.
The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain.
The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
The CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.
The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.
The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.

uWS-CT is a comprehensive software solution designed to process, review and analyze CT 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, as well as anatomical datasets. 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 provided document, a 510(k) summary for the uWS-CT software, does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets these criteria in the way typically required for AI/ML-driven diagnostics.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (uWS-CT K173001) and several reference devices for its various CT analysis applications. It lists the functions of the new and modified applications (e.g., CT Lung Density Analysis, CT Brain Perfusion, CT Heart, CT Calcium Scoring, CT Dynamic Analysis, CT Bone Structure Analysis, CT Liver Evaluation) and compares them to those of the predicate and reference devices, indicating that their functionalities are "Same."

While the document states that "Performance data were provided in support of the substantial equivalence determination" and lists "Performance Evaluation Report" for various CT applications, it does not provide the specifics of these performance evaluations, such as:

• Acceptance Criteria: What specific numerical thresholds (e.g., accuracy, sensitivity, specificity, Dice score for segmentation) were set for each function?
• Reported Device Performance: What were the actual measured performance values?
• Study Design Details: Sample size, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, or results of MRMC studies.

The document explicitly states:

• "No clinical study was required." (Page 16)
• Software Verification and Validation was provided, including hazard analysis, SRS, architecture description, environment description, and cyber security documents. However, these are general software development lifecycle activities and not clinical performance studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document suggests that the performance verification was focused on demonstrating functional equivalence rather than presenting quantitative performance metrics against pre-defined acceptance criteria in a clinical context.

Summary of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document states "Performance Evaluation Report" for various applications were submitted, but the content of these reports (i.e., the specific acceptance criteria and the results proving they were met) is not included in this 510(k) summary.

2. Sample size used for the test set and the data provenance: This information is not provided. The document states "No clinical study was required." The performance evaluations mentioned are likely internal verification and validation tests whose specifics are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. Given that "No clinical study was required," it's unlikely a formal multi-expert ground truth establishment process for a clinical test set, as typically done for AI/ML diagnostic devices, was undertaken for this submission in a publicly available manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.

5. 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: This information is not provided. The document explicitly states "No clinical study was required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states this is a "software solution intended to be used for viewing, manipulation, and storage of medical images" that "supports interpretation and evaluation of examinations within healthcare institutions." The listed applications provide "a tool for the user to perform..." or "a tool for the review and analysis..." which implies human-in-the-loop use. Standalone performance metrics are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. The document is a 510(k) summary for a software device, not a detailed technical report on an AI/ML model's development.

9. How the ground truth for the training set was established: This information is not provided.

In conclusion, the supplied document is a regulatory submission summary focused on demonstrating substantial equivalence based on intended use and technological characteristics, rather than a detailed technical report of performance studies for an AI/ML device with specific acceptance criteria and proven results. For this type of information, one would typically need access to the full 510(k) submission, which is not publicly available in this format, or a peer-reviewed publication based on the device's clinical performance.

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The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration.

The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclical structures in scanned body tissue for clinical diagnostic purposes.

DaTQUANT optional application enables visual evaluation and quantification of 1371-iofflupane (DaTscan™) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 271-ioflupane (DaTscan™) images. These applications may assist in detection of loss of functional dopamninergic neuron terminals in the striatum, which is correlated with Parkinson disease.

Q.Lung application may aid physicians in:

• · Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.
• Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe. bilobectomy or pneumonectomy.

O.Brain allows the user to visualize and quantify relative changes in the brain's metabolic function or blood flow activity between a subject's images and controls, when used with radiopharmaceuticals approved by the regulatory authority in the country of use, which may be resulting from brain function alterations in:

• · Epileptic seizures
• · Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.
• Inflammation
• Brain death
• · Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• · Traumatic Brain Injury (TBI)

When integrated with the patient's clinical and diagnostic information, O.Brain application may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries.

The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scanners and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

The Xeleris 4.0 is a Nuclear Medicine software-only device designed for general nuclear medicine processing & review procedures for detection and quantification of radioisotope tracer uptake in the patient body, using a variety of processing modes for various clinical applications types defined by anatomy and/or function of interest, radiopharmaceuticals, NM system acquisition set-up, etc., and various features designed to enhance image quality.

The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing the following additional clinical applications:

1. Q.Lung - Q.Lung application provides processing, quantification, and multidimensional review for pulmonary scintigraphy for display and quantification of global and regional ventilation (V) and perfusion (P) on SPECT and SPECT/CT studies.

2. Q.Brain - Q.Brain application features automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in control subjects. The resulting quantification is presented using volume of interests, voxel-based and 3D stereotactic surface projection maps of the brain.

Q.Brain image analysis standardizes individual brain shapes into a standard atlas shape while preserving the functional information measured by SPECT and PET imaging.

SPECT/PET co-registration to MR and fusion display capabilities allows functional findings to be related to anatomy and offers visualization of structural abnormalities.

3. Alcyone CFR – Alcyone CFR application allows for the quantification of coronary vascular function by deriving the Myocardial Blood Flow (MBF) and Coronary Flow Reserve (CFR). These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

The provided document is a 510(k) Premarket Notification for the GE Healthcare Xeleris 4.0 Processing and Review Workstation. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with explicit performance metrics.

Therefore, the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not explicitly available in the provided text for the Xeleris 4.0 device.

The document states that:

• The Xeleris 4.0 is a modification of its predicate device Xeleris 3.1 (K130884) by introducing additional clinical applications such as Q.Lung, Q.Brain, and Alcyone CFR.
• Clinical studies were not required to support substantial equivalence for Xeleris 4.0.
• "Bench measurements on representative clinical datasets were used to demonstrate the outputs of the software applications, and to substantiate their clinical performance."
• "Development and testing of the new features included use of clinically acquired data-sets to ensure the intended clinical outputs were achieved."
• Verification, including hazard mitigation, was performed with "results demonstrating the Xeleris 4.0 Processing and Review Workstation software met its design inputs and clinical performance requirements."

Without a detailed clinical study report, which is not part of this 510(k) summary, it's impossible to create the table and answer the specific questions about acceptance criteria and study details.

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