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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 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 treal ment planning and interventional radiology procedures.

SPECT: To detect or image the distribution ofradionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV

CT: The CT component is intended to produce 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.

SPECT+cT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The :MIApplications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

The following satement applies only to the Semens Symbia Intevo 16 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 (NEngl 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 stand-alone diagnostic imaqing devices.

The Symbia SPECT/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Symbia SPECT/CT systems.

The provided text is a 510(k) Summary for Siemens Symbia T16, Symbia Intevo 16, and Symbia Intevo Bold SPECT/CT systems, seeking to add an indication for low-dose lung cancer screening. It describes performance testing conducted but does not explicitly define acceptance criteria or provide specific device performance results in a table format for the lung cancer screening indication.

Instead, it relies on the substantial equivalence principle, stating that the CT component within the SPECT/CT systems is identical in design, material, functionality, technology, and energy source to previously cleared standalone SOMATOM CT systems (K142955) that already have the low-dose lung cancer screening indication. Therefore, the performance testing for the standalone SOMATOM CT systems is considered applicable.

Here's a breakdown of the requested information based on the provided document:

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

The document does not explicitly provide a table of acceptance criteria and reported device performance for the lung cancer screening indication. It states:

• "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Symbia SPECT/CT systems is likewise suitable for lung cancer screening."

The document lists various parameters that were evaluated for the general CT use and confirmed to be the same between the integrated SPECT/CT CT subsystem and the standalone SOMATOM CT systems. These parameters are:

• CT number accuracy
• CT number uniformity
• Spatial resolution (MTF, maximum in-plane resolution)
• Slice thickness/sensitivity profile (minimum slice width)
• Noise properties (NPS and image Noise (standard deviation))
• Contrast to Noise Ratio
• Maximum scan speed
• Minimum reconstructed slice interval

However, specific acceptance criteria (e.g., "CT number accuracy within X%") or quantitative performance results for these parameters are not detailed in this document. It implies that the acceptance criteria and performance data from the K142955 submission for the predicate SOMATOM CT scanners are being leveraged.

2. Sample size used for the test set and the data provenance

The document does not explicitly state a sample size for a test set related to the low-dose lung cancer screening indication. It refers 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."

This implies that external clinical studies, such as the NLST, provide the evidentiary basis for the effectiveness of low-dose CT in lung cancer screening, rather than de novo testing on a new sample set for this specific submission. The data provenance would therefore be the NLST and other referenced clinical literature, which involved large cohorts. The document does not specify if the data was retrospective or prospective for any new testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned in the document for this specific submission's performance testing. The reliance is on existing clinical evidence and the performance characteristics of the predicate device.

4. Adjudication method for the test set

Not applicable/Not mentioned in the document for this specific submission's performance testing.

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 applicable. This device is an imaging system (CT scanner), not an AI-assisted diagnostic tool.

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

This submission is about the CT system itself. The performance testing referenced is for the CT component's imaging capabilities (e.g., resolution, noise, CT number accuracy), which are inherent to the device's function as an imaging modality. The "standalone" performance is assessed by comparing its technical parameters to those of the predicate standalone CT systems. The document states:

• "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems."

7. The type of ground truth used

For the general performance parameters listed (CT number accuracy, spatial resolution, etc.), the ground truth would be established through phantom studies or calibrated measurements performed during the CT testing, which is standard for imaging system validation.

For the clinical utility for lung cancer screening, the ground truth is established through the outcomes data (e.g., reduced mortality rates) from large-scale clinical trials like the National Lung Screening Trial (NLST), as referenced in the Indications for Use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm development and training scenario specified in the document.

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

Not applicable.

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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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