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NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.

Scan&GO:
This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

Siemens intends to market a new CT scanner system NAEOTOM Alpha supporting software version, SOMARIS/10 syngo CT VA40 with mobile workflow options.
Dual Source CT Scanner System:

• NAEOTOM Alpha
• Scan&GO Mobile Medical Application (optional mobile workflow component) .
  The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA40 is a dual-source Computed Tomography (CT) x-ray system featuring two detectors based on new photon counting technology. The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the predicate devices, but support with improved technological characteristics.
  The NAEOTOM Alpha with Software SOMARIS/10 synqo CT VA40 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
  The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements.
  NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
  The software version for the NAEOTOM Alpha, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data manaqement, X-ray scan control, image reconstruction, and image archive/evaluation.
  The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.
  New software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is a modified software version based on syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the secondary predicate device and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the secondary predicate device Scan&GO cleared in (K200524).

The provided text describes a 510(k) premarket notification for the NAEOTOM Alpha CT scanner and Scan&GO application. It includes performance data from non-clinical testing.

Here's a breakdown of the requested information:

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

The document provides a general overview of performance testing and states that "all of the software specifications have met the acceptance criteria" and that verification and validation testing was "found acceptable to support the claim of substantial equivalence." However, it does not present a specific table with quantitative acceptance criteria and corresponding reported device performance metrics in a structured format for each feature. Instead, it describes the type of performance testing conducted for various features.

For example, for "Detector - QuantaMax," it mentions "in-depth evaluation of NAETOM Alpha Image Quality for general CT imaging, based on phantom evaluation of Typical Modes, compared to the predicate device SOMATOM Force. It also includes parameters for supporting the suitability of the subject device for low dose lung cancer screening." For "CARE keV," it states "The test procedure includes phantom measurements with clinically relevant phantom diameters and contrast materials to support the contrast, noise, and radiation dose related CARE keV information."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing which involves phantom studies. There is no mention of patient data (test set) being used for performance evaluation in the context of proving substantial equivalence, nor any information about data provenance (country of origin, retrospective/prospective). The testing described is performed on the device itself and phantoms.

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)

Since the testing described is primarily non-clinical (phantom studies) and doesn't explicitly involve human reader interpretation for a test set, there is no mention of experts establishing ground truth for a test set or their qualifications.

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

Given that no human reader-based test set evaluation is described for performance, there is no information on an adjudication method.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the substantial equivalence of the NAEOTOM Alpha CT scanner and its components to existing predicate devices, primarily through non-clinical performance testing and technical comparisons, not on measuring human reader performance with or without AI assistance.

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

Yes, the testing described appears to be a form of standalone algorithm-only (device-only) performance evaluation through phantom studies. The document details testing of features like "Quantum Iterative Reconstruction," "Detector - QuantaMax," "CARE keV," and "Quantum Pure Lumen" using phantom measurements and technical analyses to assess their performance characteristics, independent of human interpretation in a clinical setting.

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

For the non-clinical phantom studies, the ground truth would be the known physical properties and configurations of the phantoms (e.g., known material compositions, shapes, sizes, and concentrations of inserts). For example, for "Always Dual Energy," it mentions "phantoms with iodine inserts," where the known concentration and distribution of iodine would serve as ground truth for assessing accuracy.

8. The sample size for the training set

The document refers to the NAEOTOM Alpha as a new CT scanner system with modified software. It mentions that "software version SOMARIS/10 syngo CT VA40 is a further development of the SOMARIS/10 syngo CT VA30 software version," implying an evolution rather than a de novo AI algorithm that requires a separate training set. While the algorithms (like Quantum Iterative Reconstruction, CARE keV) have been optimized, the document does not specify a sample size for a training set in the context of distinct machine learning model training as one might expect for a typical AI/ML device. The focus is on the device's inherent imaging capabilities and reconstruction algorithms.

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

As there is no explicit mention of a training set or a distinct AI/ML model being trained with external data, there is no information on how ground truth for a training set was established. The development appears to be based on engineering principles, physics of CT imaging, and optimization of established reconstruction techniques for the new photon-counting detector technology.

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

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. 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.

Siemens intends to update software version, SOMARIS/10 syngo CT VA40 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with unmodified mobile workflow options. This update also includes optional hardware for CT guided intervention workflow for the X. platform supporting CT Scanner Systems.

SOMATOM go.Platform is comprised of the following 6 CT scanners and optional mobile workflow:

• . SOMATOM go.Up
• SOMATOM go.Now
• SOMATOM go.Top
• SOMATOM go.All ●
• SOMATOM go.Sim ●
• SOMATOM go.Open Pro
• Scan&GO Software (optional mobile workflow component) ●

SOMATOM X. platform is comprised of the following 2 CT scanners and optional mobile workflow:

• SOMATOM X.cite
• SOMATOM X.ceed (new CT Scanner Model)
• Scan&GO Software (optional mobile workflow component) .

The subject device SOMATOM go. platform and SOMATOM X. platform with SOMARIS/10 syngo CT VA40 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X. platform with software SOMARIS/10 syngo CT VA40 produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Medical Solutions USA, Inc. and other vendors. These images aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the subject device platform CT scanners. Scan&GO can be operated on a Siemens provided various tablet hardware or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with Wi-Fi connection that meets certain minimum requirements:

• Selection of patients O
• O Selection of pre-defined protocols
• Scan parameter display O
• Patient table position display and gantry tilt parameter display O
• O Tools and instruction message area,
• Patient table position planning area O
• O Physiological data display
• Patient data display (e.g. date of birth, name) O
• Display of acquired topogram and tomogram images O
• Finalization of exam (close patient) O
• Mobile Organizer, O
• O Patient Instruction Language ("API languages")
• Control function for RTP Laser systems O
• O Control of mood light functions
• predefined workflow associated question/answer dialog O

NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.

The software version, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

Software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is an update to software version syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the primary predicate devices in K200524 and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.

The provided text describes a 510(k) premarket notification for Siemens CT scanner systems (SOMATOM go. Platform and SOMATOM X. Platform) with a software update (SOMARIS/10 syngo CT VA40). The document focuses on demonstrating substantial equivalence to a predicate device (SOMATOM X.cite, K200524) rather than presenting a performance study with detailed acceptance criteria and human reader studies for a diagnostic AI.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, AUC for an AI diagnostic device) and comparative effectiveness studies with human readers is not present in this document. This submission primarily focuses on hardware and software modifications and their impact on safety and technical performance, supported by non-clinical testing and adherence to recognized standards.

However, I can extract information related to the technical acceptance criteria and the non-clinical testing performed to meet them, as implied by the document.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative clinical acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or AUC) for a diagnostic AI device, nor does it report such performance metrics. This is because the submission is for a CT scanner system with software updates, not a new diagnostic AI algorithm that independently provides a diagnosis.

Instead, the acceptance criteria relate to the technical performance and safety of the CT system and its software. The general statement is: "The test results show that all the software specifications have met the predetermined acceptance criteria."

Here's an inferred table based on the non-clinical testing described:

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of images or patients) for the non-clinical testing. It refers to "phantom tests" and "bench tests." For the lung cancer screening indication, it references the National Lung Screening Trial (NLST), which is a large prospective clinical trial, but the submission itself did not conduct a new clinical trial for this specific device. The NLST is cited as supportive literature for the clinical utility of low-dose CT in lung cancer screening, not data directly generated by this device for its performance.
• Data Provenance:
  • Country of Origin: The non-clinical tests were conducted internally by Siemens, likely at their manufacturing and development sites, which include Germany and China (as per manufacturing site listings).
  • Retrospective or Prospective: The non-clinical tests (phantom and bench testing) are inherently prospective in nature because they are controlled experiments performed during product development and verification. The NLST, referenced for lung cancer screening, was a prospective clinical trial.

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

This information is not applicable and therefore not provided in this document in the context of diagnostic AI acceptance criteria. The tests performed are non-clinical (phantom, bench tests) and mechanical/software verification, not human-in-the-loop diagnostic studies requiring expert ground truth labeling.

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

This information is not applicable as it pertains to establishing ground truth for diagnostic interpretation, which was not the focus of this non-clinical 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

An MRMC study was not conducted for this submission. This is not a submission for a new AI diagnostic algorithm but rather for updates to a CT scanner system and its core operating software. The mention of "Scan&GO Software" refers to a mobile workflow control software, not an AI diagnostic assistant.

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

A standalone performance study for an AI diagnostic algorithm was not done. The "software" being updated is the CT scanner's operating system (SOMARIS/10 syngo CT VA40) and command-based program, along with a mobile workflow control application (Scan&GO). These are not presented as standalone AI tools that provide diagnostic output.

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

For the non-clinical testing described:

• Phantom measurements/simulations: The "ground truth" or reference for these tests would be the known physical properties and configurations of the phantoms, or scientifically established benchmarks for image quality parameters.
• Simulated clinical workflow: For things like "MyNeedle Laser," the "accuracy" is likely judged against pre-defined engineering specifications for precision and workflow efficiency.
• Bench testing: Involves controlled experiments against pre-determined requirements and specifications.
• Reference to NLST: For the lung cancer screening indication for use, the ground truth for the clinical utility of low-dose CT screening itself came from the NLST study, which used clinical outcomes (e.g., reduction in mortality from lung cancer) as its primary endpoint. However, this is for the indication, not performance of this specific device's new features.

8. The sample size for the training set

This document does not refer to a training set in the context of an AI algorithm. The software update is for the CT system's operating and control software, not a machine learning model that requires a training set.

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

This is not applicable as no AI training set is discussed or implied by the nature of the software update described.

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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