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The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: Planar imaging, whole body imaging for isotopes with energies up to 588 keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.

The Siemens Symbia systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.

For all systems, a new software version synqo MI Applications VB10A supports the upgrade to Windows® 7 Operating System, updates to 3rd party software, and optional LPHR collimator imaging are available.

This document describes the Symbia 6.0, an Emission Computed Tomography (SPECT/CT) system. The information provided outlines the device's intended use, technological characteristics, and performance testing, primarily for the LPHR collimator and general system compliance. However, it does not contain detailed information about a study proving the device meets acceptance criteria in the context of AI/ML performance, human-in-the-loop studies, or specific clinical ground truths. It primarily focuses on hardware and software upgrades and compliance with regulatory standards.

Here's an analysis based on the provided text:

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

The document provides acceptance criteria and test results specifically for the LPHR collimator component of the Symbia 6.0 system, according to NEMA NU-1:2007 standards.

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

The document mentions "Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems" and "IRIS Image Quality testing has been performed with Catphan® and water phantoms on the 6 and 16 slice SPECT/CT systems." However, specific sample sizes (number of patients or specific phantom scans) for these tests are not provided. Similarly, there is no information on the data provenance (e.g., country of origin, retrospective or prospective study design) as the testing appears to be primarily technical performance evaluation using phantoms rather than clinical studies with patient data.

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 applicable. The performance testing described (for LPHR collimator and IRIS Image Quality) relies on physical phantom measurements and adherence to technical specifications (NEMA standards), not on expert clinical interpretation of images to establish ground truth.

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

Not applicable. As the testing involves physical measurements against technical specifications with phantoms, there is no clinical adjudication method described or required.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with or without AI assistance was not mentioned or implied in this document. The device is a SPECT/CT imaging system and its software, not an AI-driven diagnostic aid that would typically undergo such a study for clinical effectiveness.

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

The document describes the device as an imaging system and its associated display and analysis software. While the software ("syngo MI Applications") is intended to "aid the clinician in the assessment and quantification of pathologies," it is described as a display and analysis package rather than a standalone algorithm performing diagnostic tasks without human input. The performance testing focuses on the imaging hardware and basic image quality, not the autonomous diagnostic capability of an algorithm. Therefore, a standalone algorithm-only performance study in the context of AI performance (e.g., sensitivity/specificity for disease detection) was not detailed.

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

The ground truth for the described performance tests is based on:

• Technical specifications and physical standards: For the LPHR collimator, performance is measured against NEMA NU-1:2007 standards and internal specifications (e.g., $\le 3.84mm$).
• Phantom measurements: IRIS Image Quality testing was performed using Catphan® and water phantoms, which provide known physical properties and artifacts for image quality assessment.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI/ML model that would require a training set in the conventional sense. The "syngo MI Applications" software mentioned is a display and analysis tool, and while it might incorporate algorithms, the document does not treat it as a machine learning product requiring a distinct training and test set with clinical ground truth.

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

Not applicable. As no training set for an AI/ML model is mentioned, there is no information on how its ground truth would have been established.

In summary, this 510(k) summary focuses on the technical performance and safety of a medical imaging device (SPECT/CT system) and its related software updates, rather than the clinical performance evaluation of an AI/ML-driven diagnostic or assistive tool. Therefore, many of the requested points related to AI/ML study design are not addressed in the provided text.

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