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The Siemens Symbia VA10A Family 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 or additional uses.

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, 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 taken at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The 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 SPECTsyngo software is an acquisition, 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.

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 VA10A Family consists of Single-Photon Emission Computed Tomography (SPECT) scanner and integrated hybrid x-ray Computed Tomography (CT) and SPECT scanner.

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 imaging devices.

Siemens Symbia VA10A Family maintains the same intended use and indications for use as the commercially available Intevo Bold System of Symbia 6.7 (K200474).

Symbia VA10A Family are hybrid modality imaging systems comprised of two separate but integrated components: a gamma camera (SPECT) and a CT. The gamma camera is based on hardware and software features that generate nuclear medicine images based on the uptake of radioisotope tracers in a patient's body. The CT system (spiral CT) is designed 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.

The combination of SPECT and CT in a single device has several benefits. The SPECT subsystem images biochemical function while the CT subsystem images anatomy. The combination enables scans that not only indicate function, e.g., how active a tumor is, but precise localization, e.g., the precise location of that tumor in the body.

In addition, CT can be used to correct for the attenuation in SPECT acquisitions. Attenuation in SPECT is an unwanted side effect of the gamma rays scattering and being absorbed by tissue. This can lead to errors in the final image. The CT directly measures attenuation and can be used to create a 3D attenuation map of the patient which can be used to correct the SPECT images. The SPECT-CT scanner can be used to image and track how much dose was delivered to both the target and the surrounding tissue.

The systems consist of display equipment, data storage devices, patient and equipment supports and component parts and accessories.

Symbia VA10A update is the product name for the additional features to the approved Symbia VA10A Family (K210557). The Symbia VA10A Update devices are based on the Symbia VA10A Family. The difference lies in the additional features and update to the Indications for Use to include CT Low Dose Lung Screening (as cleared in reference device K200524). The Intended Purpose and fundamental scientific technology remain unchanged.

Proposed New Features for VA10A Family

• SMARTZoom (SZHRX) Collimator
• SMARTZoom Collimator
• Plan&Go ●
• TeamPlay ●
• High Performance ICS ●
• Automatic Quality Control
• Expert-i
• IQSPECT
• xSPECT (including xSPECT Bone and xSPECT Quant) ●
• BroadQuant
• TrueCalc ●
• Support for Third-Party Collimators
• Specialty Pallets ●

The provided document is a 510(k) summary for the Siemens Symbia VA10A Family, which is a SPECT/CT system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study. The device is a diagnostic imaging system, not an AI-powered diagnostic device in the sense of providing automated interpretations or predictions.

Therefore, many of the requested elements for an AI device (like test set size, expert ground truth, adjudication methods, MRMC studies, training set size, etc.) are not applicable or not detailed in this type of submission. The performance testing described primarily relates to technical specifications of the imaging hardware and software, and compliance with regulatory standards.

Here's an attempt to extract the relevant information based on the provided text, while also noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating compliance with regulatory standards and maintaining performance specs of the predicate devices. Specific 'acceptance criteria' in terms of clinical performance metrics (e.g., sensitivity, specificity for a diagnostic task) are not explicitly stated or measured for this submission, as it's an update to an existing system. The performance tables provided are for the intrinsic detector specifications of the SPECT component, and the CT component's performance is stated to be unchanged from a predicate device and tested against regulatory standards.

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

• Test Set Sample Size: Not explicitly stated as this is a hardware/software update rather than a clinical performance study with patient data. The "test set" in this context refers to engineering and quality assurance testing of the system's technical aspects, not a clinical validation dataset.
• Data Provenance: Not applicable. The performance testing is described as "Bench testing" and "Performance testing" conducted in accordance with NEMA and IEC standards. It doesn't involve clinical data in the sense of patient images for diagnostic performance evaluation in this specific submission.

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

• Not applicable/Not stated. The performance tests described (e.g., spatial resolution, energy resolution) are objective measurements using phantoms or calibrated instruments, not clinical interpretation by experts. For software verification and validation, "experts" would likely refer to internal engineers and testers.

4. Adjudication method for the test set:

• Not applicable/Not stated. No clinical adjudication is described.

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. This device is an imaging system (SPECT/CT scanner and associated processing software), not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images beyond providing the images themselves.

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

• Yes, in a sense. The "standalone" performance testing refers to the system's intrinsic technical performance (e.g., detector specifications, CT subsystem compliance) as measured against engineering standards. However, it's not a standalone diagnostic algorithm performance study. The SPECTsyngo software is an "acquisition, display and analysis package intended to aid the clinician," implying human-in-the-loop.

7. The type of ground truth used:

• For hardware performance (SPECT detector, CT subsystem): Physical measurements, calibrated instruments, and established engineering standards (NEMA NU-1, IEC 60601 series, 21 CFR regulations).
• For software: Functional specifications and requirements.

8. The sample size for the training set:

• Not applicable/Not stated. This is not an AI algorithm that requires a "training set" of patient data in the machine learning sense. The "training" of the device refers to its design and development processes.

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

• Not applicable.

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