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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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The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.

The OLINDA/EXM® v2.0 is a modification of OLINDA/EXM® v1.1 (K033960) and includes new human models and nuclides. OLINDA/EXM® 2.0 employs a new set of decay data recommended by the International Commission on Radiological Protection (ICRP). OLINDA/EXM® 2.0 introduces a new series of anthropomorphic human body models (phantoms), so new values of Specific Absorbed Fractions (SAF), di (T←S) were generated. These phantoms were based on updated values of the mass of the target region (mr) recommended by the ICRP. The base product design of OLINDA/EXM® V2.0 is the same as for the OLINDA/EXM® V1.1 (K033960).

The provided document is a 510(k) summary for a medical device called OLINDA/EXM v2.0. This document primarily focuses on demonstrating substantial equivalence to a predicate device (OLINDA/EXM v1.1) rather than presenting a detailed clinical study with acceptance criteria and device performance in the way one might expect for a diagnostic or therapeutic AI device.

However, based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated in the document regarding acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes, as would be common for diagnostic algorithms. Instead, the "acceptance criteria" appear to be related to the verification and validation of the software itself and its consistency with the previous version. The performance is described in terms of "good compliance" with the predicate device.

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

This information is not explicitly provided in the document. The "tests for verification and validation" are mentioned, but the specific details of a "test set" (e.g., number of cases, type of data) are not described. Given that the device calculates radiation dose based on input data regarding biodistribution and relies on established models (ICRP decay data, anthropomorphic phantoms), the testing likely involved comparing output values for a range of inputs rather than a clinical dataset of patient images.

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

This information is not explicitly provided. Since the device calculates deterministic radiation doses based on models, the "ground truth" would likely be derived from established physical and biological models, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Adjudication methods like 2+1 or 3+1 are typically used when human experts are disagreeing on interpretations for a ground truth. This is not applicable to a dose calculation software validating against established models and data.

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

This information is not explicitly provided, and it is unlikely such a study was performed or needed given the nature of the device. MRMC studies are typically for diagnostic AI systems where human readers interpret medical images. This device is a software tool for calculating radiation dose.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document implies that the "testing" described for verification and validation was a standalone evaluation of the algorithm's performance against its specifications and the predicate device. The comparison showing "good compliance" between OLINDA/EXM v2.0 and OLINDA/EXM v1.1 suggests an algorithm-only evaluation. However, the exact methodology is not detailed.

7. The Type of Ground Truth Used

The "ground truth" for this device likely refers to:

• Established physical and biological models: The document mentions "new human models and nuclides," "new set of decay data recommended by the International Commission on Radiological Protection (ICRP)," and "updated values of the mass of the target region (mr) recommended by the ICRP." These are the underlying scientific references against which the calculations would be validated.
• Outputs of the predicate device (OLINDA/EXM v1.1): The comparison showing "good compliance" with the predicate device implies that the predicate's outputs served as a reference for validating the new version.

8. The Sample Size for the Training Set

This information is not applicable/provided. OLINDA/EXM v2.0 is a deterministic calculation software based on established physical and biological models, not a machine learning or AI model that requires a "training set" in the conventional sense. It's a software tool that implements mathematical models and data.

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

This information is not applicable/provided for the same reasons as #8. The "ground truth" here is derived from scientific consensus and established data (e.g., ICRP recommendations) that are used as inputs or validation references for the software's calculations, not a "training set" for a learning algorithm.

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