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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.

Additionally, general performance testing against NEMA NU-1:2012 standards was conducted, with a general statement that "All Performance testing met the predetermined acceptance values." This includes intrinsic spatial resolution, intrinsic spatial linearity, intrinsic energy resolution, intrinsic flood field uniformity, multiple window spatial registration, intrinsic count rate performance in air, system spatial resolution with LEHR, SPECT reconstructed spatial resolution, intrinsic flood field uniformity at 25% busy time, intrinsic energy resolution at 25% busy time, energy peak position stability, and system spatial resolution at 25% busy time.

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

The documents do not specify the sample size in terms of number of patient cases or images for either the quantitative accuracy or reproducibility testing. The tests utilized "phantoms."

• Data Provenance: The data provenance is not explicitly stated as retrospective or prospective patient data. Given the use of "phantoms," the data is synthetically generated and controlled within a laboratory setting, not derived from human subjects. The testing was conducted by Siemens Medical Solutions USA, Inc.

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

This information is not provided in the document. The ground truth for xSPECT Quant accuracy was established directly through reference to the National Institute of Standards and Technology (NIST) traceable precision sources for calibration. For reproducibility, the ground truth standard is the initial measurement against which subsequent measurements are compared. These methods do not inherently require human expert consensus for establishing the ground truth values.

4. Adjudication Method for the Test Set

An adjudication method is not applicable and not mentioned. The quantitative accuracy and reproducibility tests rely on direct comparison to known physical standards (NIST traceable sources) or statistical measures of variance, rather than human interpretation that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned and likely not performed for this submission. The device (Symbia Intevo Bold) is an imaging system, not an AI-assisted diagnostic software in the sense of providing automated interpretations or workflow enhancements to human readers that would be typically evaluated in an MRMC study focused on reader performance improvement. The "MI Applications software" is a "display and analysis package" to aid clinicians in assessment and quantification, but the provided studies do not evaluate its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing described for "xSPECT Quant" and "Broad Quantification" falls under a standalone (algorithm only) evaluation. The system's ability to accurately quantify isotopes or reproduce measurements is tested intrinsically, separate from a human operator's diagnostic interpretation. The NEMA NU-1:2012 testing also evaluates the physical performance of the SPECT and CT components in a standalone manner.

7. The Type of Ground Truth Used

• xSPECT Quant (Quantitative Accuracy): The ground truth was based on a NIST traceable precision source. This is a highly accurate, objectively verifiable physical standard.
• Broad Quantification (Reproducibility): The ground truth for reproducibility essentially refers to the initial, measured values from dose calibrator dependent quantification against which subsequent measurements are compared for consistency.

8. The Sample Size for the Training Set

The documents do not provide information regarding a "training set" sample size. The Symbia Intevo Bold is a medical imaging system, and while it includes software (syngo MI Applications), the described testing focuses on the physical and quantitative performance of the imaging hardware and associated quantification algorithms, not a machine learning model that would typically have a distinct training set. The software updates mention "modifications to support features" and "software improvements," suggesting iterative development rather than a single distinct training phase for a new AI model.

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

Since no specific "training set" for a machine learning model is mentioned, details on how its ground truth was established are not provided. If the software components involve internal calibration or optimization routines, these would use internal reference data, but it's not discussed in the context of an external, validated training set as one might find for a deep learning algorithm.

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