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The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, 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, and tomographic 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/CT 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 following statement applies only to Siemens Symbia T16, and Symbia Intevo Bold systems: This CT system can be used for low dose lung cancer screening in high risk populations.* * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Siemens Symbia systems consist of Sinqle 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.

The provided text describes a 510(k) premarket notification for the Siemens Symbia 6.7 system, primarily focusing on its substantial equivalence to predicate devices and adherence to performance and safety standards. However, it does not contain information about a study proving the device meets specific acceptance criteria for AI/algorithm performance, nor does it specify detailed acceptance criteria for a new software feature.

The document states:

• Modifications: The Symbia 6.7 includes software updates, specifically enhancements to "xSPECT features" (gastric retention addition, renal processing improvement), addition of SPECT Dose Reporting, and expansion of xSPECT Quantification to support Absolute Quantification of I-131. It also notes an upgrade to Windows 10 and updated third-party applications.
• Performance Testing: It mentions "Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing." For the SPECT component, it states: "Collimator performance testing is conducted according to NEMA NU-1:2018. All Performance testing met the predetermined acceptance values." It also shows "Quantitative accuracy specifications" (Figure 3) which demonstrate "accurate quantification in phantoms for all the isotopes and collimators tested" and state that "The quantitative error for all isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria."

Based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets the acceptance criteria in the context of AI/algorithm performance, because no specific AI/algorithm performance study or associated acceptance criteria are detailed. The document primarily focuses on hardware specifications and general system performance as per NEMA standards, and software updates for existing features, rather than the introduction or validation of a new AI-driven diagnostic algorithm.

Therefore, I am unable to provide the requested information fully, particularly points 2-7, 9, as the document does not describe a study that validates new AI/algorithmic features against specific, measurable acceptance criteria in a clinical or reader study setting.

However, I can extract the general quantitative acceptance criteria mentioned for existing features:

1. Table of acceptance criteria and reported device performance (for quantitative accuracy, as stated):

Note: These criteria and performance metrics are stated to be "In phantoms for objects with negligible partial volume effect" and "incident count rate" for the Lu177 metric.

2. Sample size used for the test set and the data provenance: Not specified in the provided text for the quantitative accuracy tests beyond "in phantoms." No clinical test sets are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Ground truth appears to be based on physical phantom measurements, not expert consensus on clinical images for a new AI feature.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

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 MRMC study or AI assistance evaluation is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Quantitative accuracy specifications" appear to be standalone phantom tests, but not for a new AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the quantitative accuracy, the ground truth appears to be established through physical phantom measurements and known isotope properties, rather than clinical consensus, pathology, or outcomes data.

8. The sample size for the training set: Not applicable, as no new AI model training is described.

9. How the ground truth for the training set was established: Not applicable, as no new AI model training is described.

In summary, the provided document is a 510(k) summary for a SPECT/CT system, focusing on its substantial equivalence to predicates and adherence to established performance standards (like NEMA NU-1:2018) for its existing imaging capabilities. It does not detail the validation of a new AI/algorithmic feature with the type of acceptance criteria and study design requested in the prompt.

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The Siemens Symbia Intevo Bold is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging 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, and tomographic 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/CT 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 Intevo Bold consist of Sinqle 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.

Symbia Intevo Bold implements software version syngo MI Applications VB20A.

Modifications include:

1. Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)

2. Software updates include modifications to support features available with the CT and SPECT subsystems

3. Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes

4. Four additional touchpad sensors to cover detectors' light rails and L-arms.

Commercially available xSPECT Quant (Symbia 5.0 K131634) was expanded to support quantification of additional isotopes such as I-123 and In-111. For these isotopes, dose calibrator independent quantification is enabled by a NIST traceable sensitivity calibration method. In addition, cross calibration capabilities were added to remove dose calibrator biases and variations in SUV calculations. The system allows cross calibration of multiple dose calibrators and, once calibrated, automatically adjusts for their biases.

In addition to dose calibrator independent quantification for I-123 and In-111 support for dose calibrator dependent quantification was added for a broad range of SPECT isotopes and collimators (Broad Quantification). Dose calibrator dependent quantification neither supports NIST traceable calibration nor cross calibration and relies on sensitivity measurements based on a local dose calibrator.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents primarily focus on the quantitative accuracy and reproducibility of the "xSPECT Quant" and "Broad Quantification" features within the Symbia Intevo Bold system.

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