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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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The D-SPECT® Processing and Reviewing Workstation is intended for Processing, Reporting, Archiving, Display, Communication and Analysis of emission computerized tomography data using tools for imaging and automated review and quantification of Cardiac SPECT data.

The D-SPECT® Processing and Reviewing Workstation is intended to work with Spectrum Dynamics' D-SPECT® Cardiac Scanner System or as a separate standalone post processing workstation.

The system is intended for use by the Nuclear Medicine (NM), Radiology or Electro Physiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Dynamic, Multi-Gated) and tomographic three-dimensional scans (SPECT, Gated SPECT) acquired by gamma cameras. The system can run on a dedicated workstation or as part of Spectrum Dynamics' D-SPECT® Cardiac Scanner System. The NM data can be coupled with registered and/or fused X-Ray CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas of mIBG I-123 (AdreView tm Iobenguane I-123 Injection) or similar agents within the heart.

D-SPECT® Processing and Reviewing Workstation is intended for acceptance, transfer, display, storage, and processing of images for detection of radioisotope tracer uptakes in the patient's body. The device using various processing modes supported by the various clinical applications and various features designed to enhance image quality. The emission computerized tomography data can be coupled with registered and/or fused CT/MR scans and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Visualization tools include segmentation, color coding, and polar maps. Analysis tools include Quantitative Perfusion SPECT (QPS), Quantitative Gated SPECT (QGS) and Quantitative Blood Pool Gated SPECT (QBS) measurements, Multi Gated Acquisition (MUGA) and Heart-to-Mediastinum activity ratio (H/M). It also includes reporting tools for formatting findings and user selected areas of interest. It is capable of processing and displaying the acquired information in traditional formats, as well as in three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

D-SPECT® Processing and Reviewing Workstation is based on Windows operating system. Due to special customer requirements and the clinical focus the D-SPECT® Processing and Reviewing Workstation can be configured in the same way as the predicate device with different combinations of Windows OS based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.

D-SPECT® Processing and Reviewing Workstation is a processing workstation primarily intended for, but not limited to cardiac applications. The workstation can be a part of the FDA cleared D-SPECT® Cardiac Scanner System (K110507) or integrated to a separate standalone post processing station. "SUMO" optional application enables visual evaluation and assessment of the sympathetic innervation system of the heart by quantification of uptake ratios between regions of interest, identifying discreet uptake areas within the heart of mIBG I-123 (AdreView™ Iobenguane I-123 Injection) or similar agents.

The D-SPECT® Processing and Reviewing Workstation, a nuclear medicine workstation, underwent testing to demonstrate its safety and effectiveness.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that "The performance tests indicate that the D-SPECT® Processing and Reviewing Workstation meets the specification requirements." However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported device performance metrics are not explicitly listed in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions that a "overall performance study using a simulated phantom and a dataset of subjects" was performed.

• Test Set Sample Size: The exact number of subjects in the "dataset of subjects" is not specified.
• Data Provenance: The country of origin for the data is not specified. The document indicates the study was performed in accordance with FDA guidance for Computer-Assisted Detection Devices. It is a pre-clinical study utilizing both a simulated phantom and a dataset of subjects. It appears to be retrospective as data collection usually precedes such studies for regulatory submission.

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

This information is not provided in the document. The document mentions "automated review and quantification," but does not detail how ground truth for the subject dataset was established or if it involved expert interpretation or consensus.

4. Adjudication Method for the Test Set

The adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth on the test set is not specified in the provided text.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not explicitly mentioned or described. The study described ("overall performance study") focuses on the device's standalone performance validating its safety and effectiveness against specifications. The document also states that the device is intended for "automated review and quantification."

6. If a Standalone Study Was Done

Yes, a standalone study was done. The document states: "To demonstrate and validate the safety, effectiveness and clinical use of the modified D-SPECT® Processing and Reviewing Workstation using SUMO application, Spectrum Dynamics performed a number of validation and verification tests including overall performance study using a simulated phantom and a dataset of subjects..." This describes a study evaluating the performance of the algorithm/workstation itself.

7. The Type of Ground Truth Used

The type of ground truth used for the subject dataset is not explicitly stated. It would typically involve clinical diagnosis, often based on expert interpretation of imaging, pathology, or other clinical outcomes, but this is not detailed in the provided text. The mention of "simulated phantom" suggests a known, controlled ground truth for that part of the study.

8. The Sample Size for the Training Set

The sample size for any training set is not specified. The document describes performance tests and validation, but does not detail the development or training of any machine learning components (if present and if requiring a training set), beyond stating "automated review and quantification."

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

The method for establishing ground truth for any potential training set is not specified, as the document does not elaborate on the development or training process for the automated review and quantification tools.

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