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Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities.

Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g. dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the white matter structure in the brain or more generally the central nervous system.

The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g. over time without variable acquisition parameters) where such techniques are useful or necessary. This functionality is referred to as:

Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.

Permeability Module - the calculation of parameters related to leakage of injected contrass material from intravascular to extracellular space.

Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.

Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.

Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.

Olea Sphere V3.0 is a medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software, compliant with the DICOM standard and running on Windows or Linux operating systems.

Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information.

The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. The main features of the software are:

• Image Loading & Saving
• Image Viewing
• Image Manipulation
• Image Analysis
• Imaging Processing
• Perfusion post-processing
• Permeability post-processing
• Arterial Spin Labeling (ASL)
• Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM)
• Fiber Tracking post-processing
• Collage
• Relaxometry post-processing
• Metabolic post-processing

Depending on the purpose of the imaging, the following optional plug-in are used by the software:

• DWI (for MR imaging)
• DTI (for MR imaging)
• Perfusion (for MR and CT imaging)
• Permeability (for MR and CT imaging)
• Kinetics (for MR imaging)
• ASL (for MR imaging)
• Analysis (for MR and CT imaging)
• Olea Vision (for MR imaging)
• IVIM (for MR imaging)
• Collage (for MR imaging)
• Metabolic (for MR imaging)
• Relaxometry (for MR imaging)

The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations

The provided text describes Olea Sphere V3.0, an image processing software package, and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical study with detailed performance metrics against specific acceptance criteria.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set and data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size of AI assistance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that "Internal verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices." It also lists the main groups of tests performed as: Product Risk Assessment, Software modules verification tests, and Software validation test. However, it does not provide the specifics of these tests or their results in terms of acceptance criteria.

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