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syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality post-processing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.

The syngo.via MI Workflows software addresses the needs of the following typical users of the product:

• Reading Physician / Radiologist – Reading physicians are doctors who are trained in interpreting patient scans from PET, SPECT and other modality scanners. They are highly detail oriented and analyze the acquired images for abnormalities, enabling ordering physicians to accurately diagnose and treat scanned patients. Reading physicians serve as a liaison between the ordering physician and the technologists, working closely with both.
• Technologist – Nuclear medicine technologists operate nuclear medicine scanners such as PET and SPECT to produce images of specific areas and states of a patient's anatomy by administering radiopharmaceuticals to patients orally or via injection. In addition to administering the scan, the technologist must properly select the scan protocol, keep the patient calm and relaxed, monitor the patient's physical health during the protocol and evaluate the quality of the images. Technologists work very closely with physicians, providing them with quality-checked scan images.

The software has been designed to integrate the clinical workflow for the above users into a server-based system that is consistent in design and look with the base syngo.via platform and other syngo.via software applications. This ensures a similar look and feel for radiologists that may review multiple types of studies from imaging modalities other than Molecular Imaging, such as MR.

The syngo.via MI workflows software supports integration through DICOM transfers of positron emission tomography (PET) or nuclear medicine (NM) data, as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

Although data is automatically imported into the server based on predefined configurations through the hospital IT system, data can also be manually imported from external media, including CD, external mass storage devices, etc.

The Siemens syngo.via platform and the applications that reside on it, including syngo.via MI Workflows, are distributed via electronic medium. The Instructions for Use is also delivered via electronic medium.

syngo.via MI Workflows includes 2 workflows (syngo.MM Oncology and syngo.MI General) as well as the Scenium neurology software application and the syngo MBF cardiology software application which are launched from the OpenApps framework within the MI General workflow.

Here's a breakdown of the acceptance criteria and study details for the syngo.via MI Workflows, Scenium, and syngo MBF devices:

Acceptance Criteria and Reported Device Performance

For Lung and Lung Lobe Segmentation:

For PERCIST Liver Reference Region Placement (Binary Liver Mask, input to the algorithm):

Ask a specific question about this device

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR), syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality postprocessing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.

The syngo.via MI Workflows software addresses the needs of the following typical users of the product:

• Reading Physician / Radiologist – Reading physicians are doctors who are trained in interpreting patient scans from PET, SPECT and other modality scanners. They are highly detail oriented and analyze the acquired images for abnormalities, enabling ordering physicians to accurately diagnose and treat scanned patients. Reading physicians serve as a liaison between the ordering physician and the technologists, working closely with both.
• Technologist – Nuclear medicine technologists operate nuclear medicine scanners such as PET and SPECT to produce images of specific areas and states of a patient's anatomy by administering radiopharmaceuticals to patients orally or via injection. In addition to administering the scan, the technologist must properly select the scan protocol, keep the patient calm and relaxed, monitor the patient's physical health during the protocol and evaluate the quality of the images. Technologists work very closely with physicians, providing them with quality-checked scan images.

The software has been designed to integrate the clinical workflow for the above users into a serverbased system that is consistent in design and look with the base syngo.via platform and other syngo.via software applications. This ensures a similar look and feel for radiologists that may review multiple types of studies from imaging modalities other than Molecular Imaging, such as MR.

The syngo.via MI workflows software supports integration through DICOM transfers of positron emission tomography (PET) or nuclear medicine (NM) data, as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

Although data is automatically imported into the server based on predefined configurations through the hospital IT system, data can also be manually imported from external media, including CD, external mass storage devices, etc.

The Siemens syngo.via platform and the applications that reside on it, including syngo.via MI Workflows, are distributed via electronic medium. The Instructions for Use is also delivered via electronic medium.

syngo.via MI Workflows includes 2 workflows (syngo.MM Oncology and syngo.MI General) as the Scenium neurology software application and the syngo MBF cardiology software application which are launched from the OpenApps framework within the MI General workflow.

Here's a breakdown of the acceptance criteria and study information for the Siemens syngo.via MI Workflows, including Scenium, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Calibration Data:
  • Sample Size: Not explicitly stated, but "calibration of PET images and their corresponding SUVr and CL reference data were obtained from the GAAIN website." This implies a sufficiently large dataset for method calibration.
  • Provenance: GAAIN website (Global Alzheimer's Association Interactive Network) – likely a multinational, retrospective dataset of clinical trial data.
• Validation Data (ADNI):
  • Sample Size: Not explicitly stated, but "two independent datasets" were used for validation against ADNI CL values for florbetaben. ADNI (Alzheimer's Disease Neuroimaging Initiative) is a large, multi-center, prospective observational study primarily conducted in North America.
  • Provenance: ADNI (Alzheimer's Disease Neuroimaging Initiative), likely primarily from the USA and Canada. Prospective given the nature of ADNI.
• Validation Data (Visual Reading Agreement):
  • Sample Size: 162 patients (69 females, 93 males)
  • Provenance: Retrospective review of patients with Mild Cognitive Impairment (MCI) who underwent A-PET. The specific country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Calibration Data (GAAIN): The "standard method" for Centiloid scale calculation (Klunk et al.²) implies a consensus-derived or established expert-validated process. The number and specific qualifications of experts involved in the original GAAIN data curation are not detailed but are assumed to be highly qualified specialists in PET imaging and Alzheimer's research.
• Validation Data (ADNI): The ADNI Centiloid values are established through rigorous, expert-driven protocols. The text states "ADNI CL values," implying the ground truth was derived from the ADNI project's established methods, which involve numerous qualified experts in neurology, radiology, and nuclear medicine.
• Validation Data (Visual Reading Agreement): Patients were classified as "negative" by consensus. The number and specific qualifications of experts involved in this consensus are not explicitly stated, but it would typically involve experienced nuclear medicine physicians or radiologists specializing in neuroimaging.

4. Adjudication Method for the Test Set

• Calibration Data (GAAIN): Not explicitly stated, but the "standard method" for Centiloid score calculation suggests an established, perhaps algorithmic, adjudication or consensus process applied to the raw data.
• Validation Data (ADNI): Not explicitly stated, but the ADNI's established protocols for data analysis and Centiloid score determination would inherently involve robust, multi-expert consensus or adjudicated methods.
• Validation Data (Visual Reading Agreement): Patients were "classified as 'negative' by consensus." This indicates that multiple experts reviewed the images and reached an agreement on the classification. The specific method (e.g., 2+1, 3+1) is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance. The study primarily focuses on validating the device's output (Centiloid scores) against established standards and visual interpretations, not on human workflow improvement with AI.

6. Standalone (Algorithm Only) Performance

• Yes, standalone performance was done for the Scenium Centiloid scoring feature. The studies directly compare Scenium's calculated Centiloid scores (algorithm output) against "standard method" values (from GAAIN) and ADNI CL values. The agreement with visual reading also assesses the algorithm's standalone diagnostic accuracy in classifying patients.

7. Type of Ground Truth Used

• Expert Consensus / Established Methodology:
  • For the calibration, the ground truth was the "standard method" of Centiloid estimation as prescribed in Klunk et al.², using reference data from GAAIN, which is an established, expert-driven consortium.
  • For validation, it involved "ADNI CL values," which are considered an established ground truth in Alzheimer's research.
  • For the visual reading agreement, the ground truth was "visual-based classification" determined by expert consensus.

8. Sample Size for the Training Set

• The text does not explicitly mention a "training set" for the Scenium Centiloid scoring algorithm. The process described is a "calibration" using data from GAAIN to derive transformation equations, and then "validation" on independent datasets. It's possible the calibration data acts as a form of training/development set.
  • Calibration Data (GAAIN): Sample size not explicitly stated for the "calibration analysis" dataset.

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

• As a "training set" isn't explicitly defined, we refer to the calibration process. The ground truth for the calibration (or equations derivation) was established using "calibration of PET images and their corresponding SUVr and CL reference data obtained from the GAAIN website." This reference data itself would have been established through rigorous scientific methods and likely expert consensus within the GAAIN consortium, adhering to the "level-2 calibration analysis prescribed in Klunk et al.²" to ensure a standardized and reliable ground truth.

Ask a specific question about this device

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality postprocessing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device.

The syngo.via MI Workflows software addresses the needs of the following typical users of the product:

• . Reading Physician / Radiologist – Reading physicians are doctors who are trained in interpreting patient scans from PET, SPECT and other modality scanners. They are highly detail oriented and analyze the acquired images for abnormalities, enabling ordering physicians to accurately diagnose and treat scanned patients. Reading physicians serve as a liaison between the ordering physician and the technologists, working closely with both.
• . Technologist – Nuclear medicine technologists operate nuclear medicine scanners such as PET and SPECT to produce images of specific areas and states of a patient's anatomy by administering radiopharmaceuticals to patients orally or via injection. In addition to administering the scan, the technologist must properly select the scan protocol, keep the patient calm and relaxed, monitor the patient's physical health during the protocol and evaluate the quality of the images. Technologists work very closely with physicians, providing them with quality-checked scan images.

The software has been designed to integrate the clinical workflow for the above users into a serverbased system that is consistent in design and look with the base syngo.via platform and other syngo.via software applications. This ensures a similar look and feel for radiologists that may review multiple types of studies from imaging modalities other than Molecular Imaging, such as MR.

syngo.via MI workflows software supports integration through DIC emission tomography (PET) or nuclear medicine (NM) data, as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

Although data is automatically imported into the server based on predefined configurations through the hospital IT system, data can also be manually imported from external media, including CD, external mass storage devices, etc.

The Siemens syngo.via platform and the applications that reside on it, including syngo.via MI Workflows, are distributed via electronic medium. The Instructions for Use is also delivered via electronic medium.

syngo.via MI Workflows includes 2 workflows (syngo.MM Oncology and syngo.MI General) as the Scenium neurology software application and the syngo MBF cardiology software application which are launched from the OpenApps framework within the MI General workflow.

Here's a breakdown of the acceptance criteria and the study information for the Syngo.via MI Workflows, Scenium, and Syngo MBF device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on two areas of performance evaluation: Organ Segmentation and Tau Workflow Support. The acceptance criteria for Organ Segmentation are explicitly stated, while for Tau Workflow, the criteria are implied through correlation and agreement with existing methods.

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

• Organ Segmentation: Not explicitly stated. The algorithm used was "originally cleared within syngo.via RT Image Suite (K201444) and carried into the reference predicate device (syngo.via RT Image Suite, K220783)." This suggests the data provenance for this algorithm was tied to those previous clearances. The document implies the segmentation quality was assessed, but the specific test set size for this current submission is not provided.
• Tau Workflow Support: "more than 700 flortaucipir images from ADNI".
• Data Provenance (Tau Workflow): "ADNI" (Alzheimer's Disease Neuroimaging Initiative). This is a prospective, multi-center, North American study. The exact countries of origin of the individual images are not specified but ADNI is a U.S. led initiative with international participation.

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

• Organ Segmentation: For manual ground truth annotation, the number of experts and their qualifications are not specified.
• Tau Workflow Support: The ground truth for the "MR-based method and MR-based segmentations" used for comparison is from existing methods mentioned in the references. The number and qualifications of experts involved in establishing this historical ground truth are not specified in this document.

4. Adjudication Method for the Test Set

• Organ Segmentation: An adjudication method is not explicitly stated. The process involved "comparing a manually annotated ground truth with the algorithm result." It's common for a single expert or a consensus of experts to establish manual ground truth, but the method for resolving discrepancies or reaching consensus is not detailed here.
• Tau Workflow Support: An adjudication method is not explicitly stated. The comparison was made between the device's calculated SUVRs and those from an "MR-based method and MR-based segmentations." This implies a comparison against a pre-established or validated method rather than a multi-reader adjudication specifically for this study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done for this submission. The document explicitly states: "Clinical testing was not conducted for this submission." The evaluations focused on standalone performance and agreement with existing methods.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

• Yes, standalone performance was done.
  • Organ Segmentation: The segmentation algorithm's performance (DICE coefficient and ASSD) was assessed by comparing its output directly against manually annotated ground truth. This is a standalone evaluation.
  • Tau Workflow Support: The "SUVRs calculated on individual and composite Braak VOIs using our pipeline and our masks" were compared to an "MR-based method." This directly assesses the algorithm's standalone quantification capabilities.

7. Type of Ground Truth Used

• Organ Segmentation: Expert consensus (manual annotation) is implied ("manually annotated ground truth").
• Tau Workflow Support: Reference method (MR-based method and MR-based segmentations) and potentially expert consensus that established those reference methods. The references provided suggest established research pipelines for flortaucipir processing and ADNI publications, which would typically involve expert interpretation and validation.

8. Sample Size for the Training Set

• Organ Segmentation: The document states the algorithm is the "same algorithm originally cleared within syngo.via RT Image Suite (K201444) and carried into the reference predicate device (syngo.via RT Image Suite, K220783)." The training set size for this re-used algorithm is not specified in this document, but would have been part of the original clearance.
• Tau Workflow Support: The training set size for the tau quantification workflow is not specified.

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

• Organ Segmentation: The method for establishing ground truth for the training set of the deep-learning algorithm is not specified in this document. Given it's a deep-learning algorithm, it would typically involve expert-labeled data, but the details are not provided.
• Tau Workflow Support: The method for establishing ground truth for the training set (if applicable) for the tau quantification workflow is not specified. It mentions using the AAL atlas as a basis for defining Braak regions, which is a pre-existing anatomical atlas.

Ask a specific question about this device

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as position emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR), syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows is a multi-modality post-processing software only medical device, which is intended to be installed on common IT hardware. This hardware must fulfill the defined requirements. The hardware itself is not seen as part of the medical device.

The Siemens syngo.via platform (K191040) and the applications that reside on it are distributed via electronic medium. The Instructions for Use also delivered via electronic medium.

synqo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Scenium assists in the display and analysis of images within the MI Neurology workflow of syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium consists of four workflows:

• Database Comparison
• -Striatal Analvsis
• -Cortical Analysis
• -Subtraction

The Scenium workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy),

syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The software is launched from the OpenApps Framework within the MI Cardiology workflow within syngo.Via MI Workflows. The application supports dynamic Rubidium – PET and dynamic Ammonia – PET images. The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, such as a database comparison workflow, for the Clinician to assess these results.

The provided text describes modifications to the syngo.via MI Workflows software (specifically VB60A, Scenium VE40A, and syngo MBF VB30A versions) and asserts their substantial equivalence to a predicate device (syngo.via MI Workflows VB50A, Scenium VE30A, and syngo MBF VB20A, K201195). However, it does not contain a detailed description of acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical or performance validation study with quantitative metrics, expert adjudication, or MRMC data.

Instead, the document focuses on:

• Regulatory Compliance: Adherence to FDA regulations (21 CFR 892.2050, 21 CFR Part 807.87(h)), recognized standards (ISO 14971, EN ISO 13485, IEC 62304, NEMA PS 3.1-3.20, IEC 62366-1, ISO 15223-1), and cybersecurity guidelines.
• Functional Equivalence: Stating that the new features do not alter the existent technological characteristics or raise new issues of safety and effectiveness compared to the predicate device.
• Verification and Validation (V&V): A general statement that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values."

Without specific performance metrics and a detailed study design provided in the given text, it is not possible to fully populate all components of your request. I will extract what information is present and indicate where information is Not Provided (NP).

Acceptance Criteria and Device Performance (as inferred from the document)

The document broadly states that "All testing has met the predetermined acceptance values." However, it does not explicitly define these "predetermined acceptance values" in a quantitative table. The primary acceptance criteria appear to be substantial equivalence, functional correctness, and adherence to safety and quality standards.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: NP (Not provided in the document. The document refers to "Verification and Validation activities" and "All testing" but does not specify the number of cases or datasets used for these tests.)
   • Data Provenance: NP (Not provided. It is not stated where the data for testing originated from, e.g., country of origin, or if it was retrospective or prospective data.)

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

   • Number of Experts: NP (Given the nature of the modifications described – mainly functional additions and improvements to existing workflows – it's unlikely a traditional "ground truth" for disease diagnosis was established for this specific submission beyond ensuring the software performs its intended technical functions. If expert review was part of the V&V, it is not detailed.)
   • Qualifications of Experts: NP

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

   • Adjudication Method: NP (This type of adjudication is typically for establishing diagnostic ground truth, which is not the focus of the described V&V for these software updates.)

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:

   • MRMC Study: No. The document describes software workflow updates for viewing, manipulation, quantification, and analysis of medical images. It does not introduce an "AI" component intended to directly assist or change clinical decision-making in a way that would necessitate an MRMC study demonstrating improved human reader performance. The software is a tool for professionals, not an AI diagnostic assistant.

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

   • Standalone Performance: The V&V activities would have included testing of the software's algorithms and functions in a standalone manner to ensure they work as designed and meet specifications. However, specific metrics (e.g., accuracy, sensitivity, specificity for automated tasks) are NP for any specific algorithm. The "syngo MBF" module, for instance, calculates quantitative blood flow measurements, and its accuracy would have been part of the V&V, but no specific performance statistics are provided.

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

   • Type of Ground Truth: For the nature of these software updates, the "ground truth" would likely be technical correctness and adherence to algorithmic specifications rather than clinical outcomes or pathology. For example, ensuring that a 4D visualization works as intended, or that quantitative measurements (e.g., SUV harmonization, blood flow measurements) are mathematically correct and consistent with reference values or established methodologies. Detailed information about exactly how this "ground truth" was established (e.g., through phantom studies, simulations, or comparison with established clinical software/manual calculations) is NP.

7. The sample size for the training set:

   • Training Set Sample Size: NP. The document does not mention training sets, which implies that the updates are not based on a machine learning model that would require a distinct training phase. These are described as functional additions and improvements to existing software, not new AI/ML algorithms.

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

   • Training Set Ground Truth: NP, as no specific training set for (ML/AI) models is implied.

Ask a specific question about this device

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

synqo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Scenium is a previously cleared software device (K191309) that assists in the display and analysis of images within the MI Neurology workflow of syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium consists of four workflows:

• Database Comparison -
• -Striatal Analysis
• -Cortical Analysis
• -Subtraction

The Scenium workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).

syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The software sites within the MI Cardiology workflow within syngo.Via MI Workflows. The application supports dynamic Rubidium - PET and dynamic Ammonia – PET images. The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, such as a database comparison workflow, for the Clinician to assess these results.

The provided text is a 510(k) Summary for the Siemens syngo.via MI Workflows VB50A. It details the device's intended use and technological characteristics but does not include a study specifically testing acceptance criteria for device performance, nor does it provide a table of acceptance criteria and reported device performance.

The document indicates that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not elaborate on what these "predetermined acceptance values" or "performance requirements and specifications" were, nor does it present the results of such testing.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's what can be extracted based on the limitations:

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

• Cannot be provided. The document states that "All testing has met the predetermined acceptance values" but does not define these values or the specific performance metrics achieved.

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

• Cannot be provided. The document does not mention any specific test set, its size, or its provenance.

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)

• Cannot be provided. The document does not describe any process for establishing ground truth using experts.

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

• Cannot be provided. The document does not describe any 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

• Cannot be provided. The document does not mention an MRMC comparative effectiveness study or any effect sizes related to human reader improvement with AI assistance.

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

• Cannot be provided. The document generally describes the software features but does not provide details of standalone performance testing.

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

• Cannot be provided. The document does not specify any type of ground truth used for performance evaluation.

8. The sample size for the training set

• Cannot be provided. The document does not mention any training sets or their sizes.

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

• Cannot be provided. The document does not mention any training sets or how their ground truth was established.

Summary of what the document does provide regarding testing:

• General Statement: "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values."
• Standards Followed: Risk Management in compliance with ISO 14971, and development adhered to EN ISO 13485 and IEC 62304.
• Cybersecurity: "The Clinical Applications software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Clinical Applications software and external devices."

In conclusion, while the document indicates that verification and validation were performed and acceptance values were met, it lacks the specific details about these studies, acceptance criteria, and performance results that your request asks for. This type of detailed study information is typically found in the full 510(k) submission, not always in the public-facing 510(k) Summary.

Ask a specific question about this device

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The apports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.

The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

Scenium display and analysis software sits within the MI Neurology workflow within syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium consists of four workflows:

• -Database Comparison
• -Striatal Analysis
• Cortical Analysis -
• -Subtraction

These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).

The modifications to the syngo.via MI Workflows and Scenium (MI Neurology) software (K173897 and K173597) include the following new features:

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The document is a 510(k) summary for the syngo.via MI Workflows VB40A, Scenium device, primarily focusing on demonstrating substantial equivalence to a predicate device.

However, it does mention that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values." This generally indicates that internal testing was conducted against defined acceptance criteria, but these criteria and the detailed results are not explicitly stated.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be gathered, with limitations:

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

• Not explicitly provided. The document states "All testing has met the predetermined acceptance values," but does not list specific acceptance criteria or the quantitative performance metrics achieved.

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

• Not provided. The document does not discuss the sample size or provenance of data used for any performance testing.

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 provided. This information is absent from the text.

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

• Not provided. The document does not describe any adjudication methods.

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. The document does not mention any MRMC comparative effectiveness studies or the impact of the device on human reader performance. The device is described as a diagnostic application for viewing, manipulation, 3D-visualization, and comparison, and its role is to "complement these standard procedures," but no specific reader studies are detailed.

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

• Not explicitly stated as a standalone study in the context of clinical performance. The device itself is software-only, meaning its "standalone" functionality is its core operation. However, the document does not present specific performance metrics that would be associated with a standalone algorithm performance study (e.g., sensitivity, specificity for a particular pathology detection). It focuses on the software's ability to view, manipulate, and analyze images, and that "All testing has met the predetermined acceptance values," implying functional and performance testing, but not necessarily a clinical standalone performance study in the way AI algorithms are often evaluated for diagnostic accuracy.

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

• Not provided. The document does not specify how ground truth was established for any testing.

8. The sample size for the training set

• Not provided. The document does not discuss any training sets, suggesting that this device might not involve a machine learning model that requires a distinct training phase in the traditional sense, or at least that information is not part of this 510(k) summary. Given the device's description as an "Image Processing Software" that provides "analytical tools," it's more likely rule-based or using established algorithms rather than a deep learning model requiring extensive training data.

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

• Not applicable / Not provided. As no training set information is given, this question cannot be answered.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to quality systems and standards (ISO 14971, IEC 62304), rather than detailing specific clinical performance studies with acceptance criteria, ground truth, or reader study results. The statement about "All testing has met the predetermined acceptance values" is a general confirmation of internal verification and validation.

Ask a specific question about this device

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology envirents.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

The syngo.via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

The provided text primarily focuses on the submission of a 510(k) premarket notification for syngo.via MI Workflows VB30A and its substantial equivalence to a predicate device (syngo.via MI Workflows VB20). It outlines the device's intended use, technological characteristics, and compliance with various regulatory standards.

However, the document does not contain the detailed information necessary to fully answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria. The text mentions that "Verification and Validation activities have been successfully performed on the software package," and "All testing has met the predetermined acceptance values," but it does not provide specific numerical acceptance criteria, reported performance values, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.

Therefore, I cannot populate all sections of the table or provide detailed answers to items 2-9.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Missing Information: Specific numerical or qualitative acceptance criteria for particular features (e.g., accuracy of 3D visualization, quantification precision, speed of processing) and the actual reported performance values are not detailed in this document.

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

• Missing Information: The document states "Verification and Validation activities have been successfully performed," but does not provide any specifics about the sample size of the test set, the provenance of the data used for testing, or whether it was retrospective or prospective.

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)

• Missing Information: This information is not present in the provided text.

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

• Missing Information: This information is not present in the provided text.

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

• Missing Information: The document outlines the device as a "medical diagnostic application for viewing, manipulation, 3D-visualization and comparison of medical images" and explicitly states it is a "complement to these standard procedures." It does not describe any MRMC comparative effectiveness study, nor does it provide any effect size for human reader improvement with or without AI assistance. The device is software for image manipulation and viewing, not an AI for interpretation in the sense of directly assisting reader decisions, but rather providing tools.

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

• Missing Information: This document does not detail any standalone performance studies. The device is described as an application for viewing and manipulation, implying human interaction.

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

• Missing Information: This information is not present in the provided text.

8. The sample size for the training set

• Missing Information: The document describes the device as a software platform with new features added to a predicate device. It does not mention any "training set" in the context of machine learning, suggesting this is not a machine learning device that requires a training set in the typical sense.

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

• Missing Information: As no training set is mentioned in the context of machine learning, there is no information on how its ground truth would be established.

Summary of what the document does convey:

• The device (syngo.via MI Workflows VB30A) is a software-only medical device for medical image viewing, manipulation, 3D-visualization, and comparison from multiple modalities and time-points.
• It is an updated version of a predicate device (syngo.via MI Workflows VB20) with new features in specific workflows (MM Oncology, MI Neurology, MI Cardiology, MI Reading / SPECT Processing).
• It is intended to run on the Siemens syngo.via software platform.
• Siemens claims substantial equivalence to the predicate device and states that "no changes that raise any new issues of safety and effectiveness."
• Verification and validation activities were successfully performed, and all testing met predetermined acceptance values.
• The device complies with various recognized industry standards (ISO 14971, IEC 62304, NEMA PS 3.1 - 3.20, IEC 62366, ISO 15223-1).

Ask a specific question about this device

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo via MI workflows support the interpretation and evaluation and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

The syngo.via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

The modifications to the syngo.via MI Workflows (K160426) include the following new features:

MM Oncology Multi-foci-Segmentation Quick Quant Updates to OncoBoard VA20 Customer acceptance/ usability improvements MI Neurology:

Ability to set a default layout for Neurology studies

MI Cardiology:

Updates / redeployment to third party software Improved launching performance of third party software

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the syngo.via MI Workflows, a software-only medical device. However, it does not contain specific acceptance criteria or quantitative performance metrics for the device's diagnostic capabilities. The submission focuses on the substantial equivalence of the updated software version (VB20A) to a previously cleared version (VB10B), emphasizing that the new features do not alter the fundamental technological characteristics or raise new safety/effectiveness issues.

Therefore, a table with specific acceptance criteria and reported device performance cannot be generated from the given text. The document refers to "predetermined acceptance values" for internal verification and validation but does not provide these values publicly.

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

The document mentions "Verification and Validation activities have been successfully performed on the software package," but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number of experts used to establish ground truth for any test set or their qualifications.

4. Adjudication Method:

The document does not provide information on any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The focus is on the software's capabilities for visualization, manipulation, and analysis, not comparative diagnostic performance.

6. Standalone Performance Study:

The document describes the device as "software only" and details its features for "viewing, manipulation, 3D-visualization and comparison of medical images." It states that "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures." This indicates that the device is intended for human-in-the-loop use as a tool to aid interpretation, rather than a standalone diagnostic algorithm. Therefore, a standalone performance study in the sense of an algorithm-only diagnostic output is not described or implied.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used for any testing.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The submission is for an updated version of existing software, and details about initial development or machine learning training are not included.

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

The document does not provide information on how the ground truth for any training set was established.

Ask a specific question about this device

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo via MI workflows support the interpretation and evaluation and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

The SPECT Processing feature resides within synqo.via MI Workflows and is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens synqo.via MI Workflows software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

The modifications to the syngo.via MI Workflows (K151192) include the addition of the SPECT (Organ) Processing feature within the MI Reading workflow. This feature will integrate already existent functionality from Symbia 6.0, MI Applications (K142006) and provide the user additional organ-specific functionality for Nuclear Medicine (NM) and SPECT images within the syngo.SPECT Processing workflow.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device syngo.via MI Workflows meets those criteria. Instead, it describes the device, its intended use, and its equivalence to a predicate device for the purpose of 510(k) clearance by the FDA.

The text states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitiqations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not provide the specifics of these "predetermined acceptance values" or the "performance requirements and specifications."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance. The document broadly states "All testing has met the predetermined acceptance values" but does not define these values or present specific performance data.
• Sample size used for the test set and the data provenance. This information is not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This information is not present.
• Adjudication method for the test set. This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done. This information is not present. The document focuses on showing equivalence to a predicate device rather than comparative effectiveness.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. This information is not present. The device is described as a tool to aid human interpretation ("The clinician retains the ultimate responsibility...").
• The type of ground truth used. This information is not present.
• The sample size for the training set. This information is not present.
• How the ground truth for the training set was established. This information is not present.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include the information you've requested.

Ask a specific question about this device

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo via MI workflows support the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

The Total Lesion Glycolysis (TLG) feature resides within synqo.via MI Workflows and is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

synqo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

The modifications to the syngo.via MI Workflows (K151192) include the addition of the Total Lesion Glycolysis (TLG) feature within the MM Oncology workflow. This feature will provide the ability for the user to calculate and display the TLG for a given volume of interest (VOI) in addition to calculating and trending the summed Molecular Tumor Volume (MTV) for all VOIs defined for the given PET series.

The provided text is related to a 510(k) premarket notification for a medical device called "syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature." This document describes the device, its indications for use, and claims substantial equivalence to a previously cleared device (K151192).

However, the document does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria, as typically found in a clinical study report. The document states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values." This is a general statement and does not provide specific acceptance criteria or the study details.

Therefore, I cannot fully answer your request based on the provided text. I can, however, extract what little information is present about performance and testing.

Here's an analysis of the provided text, highlighting what can and cannot be answered:

Acceptance Criteria and Study for syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature

Based on the provided FDA 510(k) summary, specific acceptance criteria and detailed study information are not explicitly stated in a quantifiable manner (e.g., sensitivity, specificity, accuracy thresholds with corresponding confidence intervals). The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining general software validation processes.

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully answered: The document does not provide a table of quantifiable acceptance criteria or reported device performance metrics such as sensitivity, specificity, or accuracy for the TLG feature. It only broadly states: "All testing has met the predetermined acceptance values."

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

Cannot be answered: The document does not specify the sample size used for any test set or the provenance of any data (e.g., country of origin, retrospective or prospective) used for performance evaluation of the TLG feature.

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

Cannot be answered: The document does not mention the number of experts or their qualifications used to establish ground truth for any testing of the TLG feature.

4. Adjudication Method for the Test Set

Cannot be answered: The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Cannot be answered: The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, nor any effect size.

6. Standalone (Algorithm Only) Performance Study

Partially Answered: The device is described as "software only" and provides "analytical tools to help the user assess, and document changes." This implies that the TLG feature itself performs calculations and provides numerical results. The general statement "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met" suggests that the standalone performance of the algorithm for calculating TLG was evaluated to ensure its functionality and accuracy against specified requirements. However, no specific metrics or study details for this standalone performance are provided.

7. Type of Ground Truth Used

Cannot be answered: The document does not specify the type of ground truth used for any testing (e.g., expert consensus, pathology, outcomes data). In the context of a calculation feature like TLG, ground truth would typically refer to a validated reference method for calculating TLG, but this is not detailed.

8. Sample Size for the Training Set

Cannot be answered: The document does not mention a training set or its sample size. This is a software feature update to an existing platform, and typically training sets are more relevant for machine learning algorithms which are not explicitly described as being part of this specific TLG feature's core functionality beyond calculation.

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

Cannot be answered: Since no training set is mentioned, how its ground truth was established cannot be answered.

Summary of Available Information from the Document:

The 510(k) summary for syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature focuses on demonstrating substantial equivalence to a predicate device (K151192) and confirming general software validation practices. It explicitly states:

• "The features introduced into syngo.via VB10B had no impact on the technological characteristics already present in the commercially available predicate system."
• "There are no differences in the Indications for Use or Fundamental Technological Characteristics of the synqo.via MI Workflows as compared to the currently commercially available software (K151192)."
• "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values."

This document serves as an FDA clearance declaration based on substantial equivalence, not a detailed technical report of a new device's performance validation study.

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