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UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

UniSyn Molecular Imaging (MI) is a Software as a Medical Device (SaMD) that supports the visualization, manipulation and analysis of medical image data acquired or used in radiology and nuclear medicine centers. UniSyn Ml is only intended to be used by qualified radiology and nuclear medicine professionals. Univer-interface components: a patient study browser and the UniSyn MI viewer. The software is available in both thick and can be integrated to launch from PACS software.

Using UniSyn MI users can coregister anatomical and visualize them in fused and/or standalone display, e.g. single or multi-modal combinations of PET, SPECT, CT, and MR images. Users can also visualize and process planar nuclear medicine (NM) images acquired as single of multi-frame images. The layout of the UniSyn MI viewer is highly customisable, a typical layout for a PET/CT study would include of the PET and CT series in multiplanar reformatted (MPR) views as well as a 3D maximum-intensity (MIP) projection rendering of the PET series.

UniSyn MI provides tools to zoom, pan, stack, and window-level the displayed series. Our triangulation tool can be used to localize a single anatomical point of interest among all MPR and MP views of the rest (RO) tools are available to delineate 2D and 3D regions and then compute image statistics within those regions, e.g. ROI area/volumes, minimum, mean and standard deviation of image pixel values. Various image segmentation tools are included with UniSyn MI to facilitate ROI delineation based on image pixel data.

UniSyn MI includes a tool for absorbed dose estimation associated with internally deposited with diagnostic and therapeutic medical procedures. Absorbed dose estimates are based on single- or multi-time point activity measurements of molecular images and absorbed dose coefficients (S-Values) that are based on computational human models.

Once a user has completed their review or analysis of a given study, UniSyn MI provides tools to generate reports and export exemplary image data to share with referring physicians to substantiate their findings.

The medical device described in the document is "UniSyn Molecular Imaging (6-3-1)". It is a software application for image registration, fusion display, and analysis of medical image data (CT, PET, SPECT, MR) used by radiology and nuclear medicine professionals. It also estimates radiation dose from internalized radioactivity.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

UniSyn is a software only package designed for use on Intel Pentium and higher compatible computers running Microsoft Windows XP and later operating systems. It loads and writes images using a proprietary format.

UniSyn provides the following features:

• manual registration of images, where users can use user interface widgets to align the images in three dimensions;
• automated registration of images from hybrid PET-CT and SPECT-CT scanners, which provide the registration parameters in their image headers;
• multi-planar reformat (MPR) and image triangulation using cursors: linked transverse, sagittal and coronal views. When the user moves a cursor on one view, the corresponding orthogonal planes of the image are computed and displayed on the other.
• image fusion with variable opacity
• Maximum Intensity Projection (MIP)
• 3D Render
• Surface Render
• 2D regions of interest and 2D statistics such as area
• 3D volumes of interest and 3D statistics such as volume, average Standard Uptake Value (SUV) and maximum SUV
• user configurable layouts: type of image (ie which modality and what type of display: one of MIP, MPR/), size, color map, position - can be preconfigured;
• triangulation from MIP image: if the user clicks on the MIP image when it is in the coronal view, the MPR/fusion displays will update their position to that point
• color maps individually assigned for fusion and non-fusion views
• screen capture to clipboard and to disk

The provided text for KO81997 does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the manner requested.

Instead, this document is a 510(k) summary for a medical device (UniSyn) seeking clearance based on substantial equivalence to predicate devices, rather than comprehensive performance testing against numerical acceptance criteria.

However, based on the information provided, I can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for UniSyn does not define explicit "acceptance criteria" in a quantitative sense (e.g., accuracy percentages, sensitivity/specificity thresholds) or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to predicate devices by comparing features.

Here's an attempt to structure a table based on the provided information, emphasizing the comparison to predicates as the "performance" described:

Important Note: The "acceptance criteria" here are implicitly "having features substantially equivalent to the predicate devices." The document explicitly states: "UniSyn is substantially equivalent to the predicate devices Syntegra and Medical Image Merge, in terms of its image processing and display capability. UniSyn does not introduce any new features or issues of safety and effectiveness."

The following information is largely not present in the provided 510(k) summary for KO81997. The document is for a software device seeking clearance based on substantial equivalence, which typically does not require extensive clinical studies or detailed performance metrics against ground truth like a novel diagnostic algorithm might.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document does not describe a specific test set or data used for performance evaluation in the context of clinical accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not provided. Ground truth establishment for a test set is not discussed as no such test set for performance evaluation is detailed.

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

• Not provided. No test set or adjudication method is described.

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

• Not conducted/described. This device is an image processing and display software for image fusion, not a diagnostic AI algorithm intended to assist human readers in a comparative effectiveness study. Its purpose is to present existing image data in a fused format, similar to its predicates.

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

• Not applicable/described as a standalone performance study. The device is software for image manipulation and display, which inherently relies on user input for tasks like manual registration and region of interest definition. Its "performance" is in its ability to execute these functions as expected, similar to the predicates.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not provided/applicable. Given the nature of the device (image processing/fusion software) and the 510(k) pathway, these types of ground truth for performance evaluation are not discussed. The "ground truth" for this type of device would likely be its success in accurately performing image registration and display functions, which is assessed through technical verification and validation, rather than clinical outcome data.

8. The sample size for the training set

• Does not apply / Not provided. The document does not describe a "training set" in the context of machine learning or AI. UniSyn is described as software that performs image registration and display functions based on programmed algorithms, not trained models.

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

• Does not apply / Not provided. As there is no described training set, there is no mention of how ground truth would be established for it.

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