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The Symbia Pro.specta systems are 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 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.

There are no known contraindications.

The Siemens Symbia Pro.specta VA30A 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 Pro.specta VA30A Family maintains the same intended use and indications for use as the commercially available Symbia Pro.specta VA20A family (K231102).

Symbia Pro.specta VA30A 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 Pro.specta VA30A release is the product name for the addition of features to the approved Symbia Pro.specta VA20A Family (K231102). The Symbia Pro.specta VA30A devices are based on the Symbia Pro.specta VA20A Family. The difference lies in the additional features/changes. The Intended Purpose and fundamental scientific technology remain unchanged.

Proposed new features in Symbia Pro.specta VA30 include:

• Cardiac Quantification
• High Speed Mode
• . NM Remote Reconstruction on myExam Satellite

Other changes:

• Scanning improvements
• Recon improvements ●
• General software improvements ●
• Miscellaneous improvements ●

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document primarily describes the device, its intended use, and its equivalence to a predicate device, as well as a list of performance tests and standards it complies with. It does not provide specific acceptance criteria values or detailed study results with sample sizes, expert qualifications, or adjudication methods for studies proving the device meets those criteria.

Ask a specific question about this device

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 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, 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 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 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 (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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 stand-alone diagnostic imaging devices.

The provided text, K241898, describes a 510(k) premarket notification for Siemens Healthineers' Symbia SPECT and SPECT/CT Systems (Symbia VB23), which are updates to existing devices. The submission indicates that there are no significant changes to the fundamental technology or indications for use compared to the predicate device (Symbia 6.7 (VB22), K200474). Therefore, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance metrics like sensitivity, specificity, or reader improvement.

Instead, the submission focuses on demonstrating substantial equivalence by highlighting that the core performance specifications of the SPECT detector and CT subsystem remain unchanged from the predicate device and that the updated system continues to comply with relevant safety and performance standards.

Here's an analysis of the information available in the document and a clear statement of what is not present regarding device performance studies:

What is present in the document:

• Acceptance Criteria (Implied / Compliance-based) and Reported Performance: The acceptance criteria are primarily implied through adherence to performance standards and regulations.
  • CT Subsystem Performance: "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. Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment." These standards include various parts of 21 CFR 1020.30, 21 CFR 1020.33, 21 CFR 1040.10, and 21 CFR 1040.11.
  • SPECT Detector and Collimator Performance: "Collimator performance testing is conducted according to NEMA NU-1:2018. All Performance testing met the predetermined acceptance values." The "Detector Specifications" (Figure 2) and "Quantitative Accuracy Specifications" (Figure 3) list specific numerical values for intrinsic spatial resolution, energy resolution, flood field uniformity, count rate performance, system spatial resolution, system planar sensitivity, and quantitative error. These serve as the quantitative acceptance criteria for the SPECT component, and the document states: "The quantitative error for all isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria."
  • Software Validation: "Verification and validation of Siemens software is performed in accordance with documented procedures, test plans and specifications." This ensures functionality and quality.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Information NOT present in the document regarding a clinical performance study (e.g., for an AI/CAD algorithm):

The document does not describe a clinical study in the typical sense of evaluating the device's diagnostic performance (e.g., sensitivity, specificity, accuracy) using patient data with established ground truth. This is because the submission is for an updated version of an imaging system, not an AI/CAD software that provides diagnostic interpretations. The "syngo MI Applications software" is described as a "display and analysis package intended to aid the clinician," not as a tool that provides automated diagnostic outputs.

Therefore, the following points remain unaswered by the provided text:

1. Sample size used for the test set and the data provenance: Not applicable as no clinical test set for diagnostic performance evaluation is mentioned. The performance testing described is likely phantom-based or engineering-level.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the system's physical performance is established by NEMA standards and engineering measurements, not clinical expert consensus.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this device itself is not an AI/CAD system for diagnostic assistance, but an imaging scanner.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing cited (NEMA, CFR standards), the ground truth is established by the known physical properties of phantoms and calibrated measurement devices, ensuring the system outputs accurate measurements as per its specifications.
7. The sample size for the training set: Not applicable. This is an imaging system, not a machine learning algorithm requiring a training set in the typical sense. Software "verification and validation" is mentioned to ensure functionality, which refers to standard software development lifecycle testing, not ML model training.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a SPECT/CT imaging system update, focusing on demonstrating substantial equivalence to an existing predicate device and compliance with established performance standards and regulations rather than presenting a clinical performance study of a diagnostic AI algorithm.

Ask a specific question about this device

The Siemens Symbia Pro.specta VA20A Family is intended for use by appropriately wained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, turnors, 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, 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 Pro.specta VA20A 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 Pro.specta VA20A Family maintains the same intended use and indications for use as the commercially available Symbia Pro.specta VA10A family (K212604).

The provided text describes a 510(k) premarket notification for the Siemens Symbia Pro.specta VA20A Family, which is a hybrid SPECT/CT imaging system. The submission claims substantial equivalence to a predicate device (Symbia Pro.specta VA10A family, K212604), and therefore, the information provided focuses on demonstrating that the new device does not raise new questions of safety or effectiveness and maintains comparable performance.

It's important to note that a 510(k) submission primarily relies on demonstrating equivalence rather than conducting de novo clinical performance studies for the entire system's diagnostic accuracy. As such, the information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be focused on engineering and performance testing to demonstrate that the changes implemented do not degrade the established performance of the predicate device, rather than a clinical study evaluating diagnostic accuracy (e.g., against human readers).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily related to maintaining or improving the technical performance of the imaging components (SPECT and CT) and the software, without introducing new risks or altering the fundamental scientific technology or intended use.

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

The document primarily describes engineering and software performance testing, not a clinical study on patient data for diagnostic accuracy.

• Sample Size: Not applicable in the context of patient data test sets for diagnostic accuracy. The testing described is component-level and system-level verification and validation. For instance, for SPECT detector specifications, the "sample size" would relate to the number of measurements taken on a phantom or test object. The document states, "All Performance testing met the predetermined acceptance values," implying these tests were conducted sufficiently.
• Data Provenance: Not applicable in the traditional sense of patient data. The testing is internal to Siemens, likely conducted in their labs or on their manufactured devices. The document does not specify country of origin for any "data" used, as it's not a clinical trial. The testing is prospective in the sense that it's performed on the newly developed device and its components to verify performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable in the context of this 510(k) submission. The "ground truth" for detector performance and software functionality is established by engineering specifications, validated test procedures, and physical measurements against known standards (e.g., NEMA NU-1 phantoms). There is no mention of human expert consensus for interpreting images for diagnostic performance, as this submission is for an imaging system update, maintaining the predicate's intended use and performance characteristics, rather than proposing a new AI diagnostic algorithm.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of images requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The submission focuses on demonstrating the technical performance and safety of the updated integrated imaging system.

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

This question is geared towards AI/CAD systems. While the device includes software updates, including "MI View&GO updates" which incorporate "MI Neurology, Auto Lung 3D and syngo.MBF" (which could imply some level of automated analysis or display), the document does not describe them as standalone diagnostic algorithms requiring a separate performance study. The software is an "acquisition, display and analysis package intended to aid the clinician." The focus is on the integrated hardware and software system maintaining its predicate's performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described is based on:

• Physical Measurements against established standards: For SPECT, this is NEMA NU-1 phantoms and specifications. For CT, it involves compliance with IEC 60601-2-44 and 21 CFR 1020.33.
• Software Requirements/Specifications: For software functionality, the ground truth is whether the implemented features perform according to their design specifications.
• Risk Analysis Outcomes: The ground truth for safety is the successful mitigation of identified risks as per ISO 14971.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data, as this is demonstrating substantial equivalence of a general imaging system, not the diagnostic accuracy of a specific AI feature.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of a specific AI/ML algorithm that would require a "training set" in the machine learning sense. The software updates are described as "incremental improvements" and additions of existing modules (like MI Neurology, Auto Lung 3D from K222172) rather than a newly trained AI model.

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

Not applicable, as there is no described training set for an AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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 introduces 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.

The Symbia VA10A project will integrate the aCTivate platform within this release.

"Symbia VA 10A" is the product name for a new line of Siemens MI SPECT-CT products. The Symbia VA10A Family devices are based on the Symbia Intevo Series. The difference lies in the new name and updated CT. The Intended Purpose, Indications for Use and fundamental scientific technology remains unchanged. The changes included in this submission do not affect the safety and effectiveness of the device.

The provided text is a 510(k) summary for the Siemens Symbia VA10A Family of SPECT/CT systems. It describes the device, its intended use, and claims substantial equivalence to a predicate device (Symbia Intevo Bold).

Unfortunately, this document does not contain the detailed information required to answer your specific questions about the acceptance criteria and the study that proves the device meets those criteria, especially regarding AI/algorithm performance.

The document discusses performance testing for the CT subsystem (citing IEC 60601-2-44 and US regulations) and general SPECT performance (citing NEMA NU-1). However, it does not mention any specific acceptance criteria for AI or algorithmic performance, nor does it describe a study design that would evaluate such performance with quantitative metrics like sensitivity, specificity, or AUC, or MRMC studies.

The "Software" section under "Indications for Use" states: "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 is a general statement about software functionality but doesn't detail any specific AI-driven analysis or how its performance would be measured against defined criteria.

The information provided suggests that the submission focuses on the hardware and core software functionalities of a SPECT/CT system, rather than a novel AI-driven diagnostic or assistive algorithm for which detailed performance studies would typically be required for a 510(k) clearance seeking to demonstrate substantial equivalence for that specific AI feature.

Therefore, based solely on the provided text, I cannot fill out the requested table or answer most of your detailed questions regarding acceptance criteria and AI performance studies.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study for AI/Algorithm Performance (Information NOT available in the provided text)

The document primarily focuses on demonstrating substantial equivalence of the new SPECT/CT system (Symbia VA10A Family) to a predicate device (Symbia Intevo Bold) based on hardware components and existing functionalities. It explicitly states: "The Intended Purpose, Indications for Use and fundamental scientific technology remains unchanged. The changes included in this submission do not affect the safety and effectiveness of the device." This suggests that no novel AI algorithms requiring new performance studies were part of this specific 510(k) submission.

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

• Not explicitly provided for AI/algorithmic performance. The document lists detector specifications for SPECT (Intrinsic spatial resolution, Intrinsic spatial linearity, Intrinsic energy resolution, Intrinsic flood field uniformity) and general CT performance standards (21 CFR 1020.30, 1020.33, etc.), but these are for the imaging system itself, not a specific AI-driven diagnostic or analytical tool.

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

• Not provided. No details on a test set for AI/algorithm performance.

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

• Not provided. No details on ground truth establishment for AI/algorithm performance.

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

• Not provided.

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 provided/Applicable. The document does not describe any MRMC study for AI assistance.

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

• Not provided/Applicable.

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

• Not provided.

8. The sample size for the training set

• Not provided.

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

• Not provided.

Information that is available in the provided document, but pertains to the overall system, not specific AI algorithms:

• Device Name: Symbia VA10A Family
• Manufacturer: Siemens Medical Solutions USA, Inc.
• Product Code: KPS (Emission Computed Tomography System), JAK (Computed Tomography X-Ray System)
• Regulatory Class: Class II

Performance Testing (General System):

• CT Subsystem: Performance testing was included in the original premarket notification for the CT subsystems (K200524). Tested against:
  • 21 CFR 1020.30 (a), (b)(36)(iii)-(v), (b)(58)-(62), (h)(3)(vi)-(viii)
  • 21 CFR 1020.33 Computed Tomography (CT) equipment
  • 21 CFR 1040.10 Laser Products
  • 21 CFR 1040.11 Specific purpose laser products
  • IEC 60601-2-44
• SPECT System:
  • Performance testing is conducted according to NEMA NU-1.
  • All Performance testing met the predetermined acceptance values.
  • Specific Detector Specifications (for Tc99m):
    • Intrinsic spatial resolution (FWHM in CFOV: ≤3.8 mm, FWHM in UFOV: ≤3.9 mm; FWTM in CFOV: ≤7.5 mm, FWTM in UFOV: ≤7.7 mm)
    • Intrinsic spatial linearity (Differential in CFOV: ≤0.2 mm, Differential in UFOV: ≤0.2 mm; Absolute in CFOV: ≤0.4 mm, Absolute in UFOV: ≤0.7 mm)
    • Intrinsic energy resolution (FWHM in CFOV: ≤9.9%)
    • Intrinsic flood field uniformity (uncorrected) (Differential in CFOV: ≤2.5%, Differential in UFOV: ≤2.7%; Integral in CFOV: ≤2.9%, Integral in UFOV: ≤3.7%)
  • States that NEMA detector and collimator performance specifications do not change, and there are no changes in system design impacting SPECT performance.

Software Specifics:

• "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."
• "Verification and validation of Siemens software is performed in accordance with documented procedures, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software verification, and system testing."
• "System and System Integration testing (validation) was carried out for all features of the project, and all planned test cases were executed."
• Verification and Validation aims to: ensure functionality, quality, risk mitigation, identify issues, and ensure specifications meet intended use.

Cybersecurity:

• Mentions cybersecurity controls to prevent unauthorized access, modifications, misuse, or denial of use, and unauthorized use of information. Adheres to FDA Guidance (Oct 2, 2014).

In conclusion, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of updated hardware and general software functionalities of a SPECT/CT system to a predicate device, rather than the performance of a distinct AI/algorithmic component with specific diagnostic claims. Therefore, the detailed questions about AI acceptance criteria and study design cannot be answered from this document.

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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 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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 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 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.

The provided document is a 510(k) Pre-market Notification from Siemens Medical Solutions, USA, Inc. to the FDA for their Symbia 6.5 device. This document primarily focuses on establishing substantial equivalence to a predicate device (Symbia 6.0) rather than presenting a detailed clinical study for a novel AI/software component, which is what the prompt's questions imply by asking for "human readers improve with AI vs without AI assistance" or "stand alone (i.e. algorithm only without human-in-the-loop performance)."

The document discusses updates to the Symbia device, including upgraded software and the integration of commercially marketed CT software and a viewing application. The "syngo MI Applications software" is described as a display and analysis package intended to aid clinicians. However, the performance testing section does not describe a clinical study of an AI algorithm in the way the prompt specifies. Instead, it focuses on physical performance characteristics of the SPECT/CT system, specifically quantitative accuracy using phantoms, and refers to electrical, mechanical, and radiation safety standards.

Therefore, many of the requested details about acceptance criteria and study design for an AI-powered diagnostic device are not present in this document. The document describes performance testing for a medical imaging system, not a specific AI-driven diagnostic or assistive algorithm for image interpretation that would involve human readers or ground truth established by experts.

Given the information provided in the document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance reported relate to the quantitative accuracy of the SPECT system, not a specific AI diagnostic algorithm.

Ask a specific question about this device

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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