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The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.

The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis

syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:

• Myocardial blood flow (MBF) image .
• Myocardial blood volume (MBV) image ●
• Flow Extraction Product (FE) image ●
• Perfused Capillary Blood Volume (PCBV) image ●
• Extravascular Extracellular Volume (EEV) image
• Time to Peak (TTP) image ●
• Time to Start (TTS) image ●
• Tissue Transit Time (TTT) image ●
• Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image

This premarket notification (K150713) for syngo.CT Myocardial Perfusion states that it is a post-processing image analysis software that offers quantitative analysis of dynamic CT data of the myocardium following contrast media injection. It calculates myocardial blood flow (MBF), myocardial blood volume (MBV), and other hemodynamic parameters to evaluate perfusion disturbances caused by coronary artery disease.

The device is considered substantially equivalent to the predicate device, syngo® Volume Perfusion CT Body (K092013). The modifications made to the predicate include:

• Separation of the Myocardial Perfusion algorithm into a stand-alone software application.
• Migration to the syngo.via client-server software platform.
• Updated Graphical User Interface (GUI).
• Additional option to store image results as Enhanced CT.
• Parallel display of several time attenuation curves (TAC).
• A modified Indication for Use specific to Myocardial Perfusion.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "the test results show that all of the software specifications have met the acceptance criteria." However, it does not provide a quantitative table of specific acceptance criteria values and corresponding device performance metrics. Instead, it relies on general statements about verification and validation testing.

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

The document mentions "verification and validation testing" and "integration and functional tests." However, it does not specify the sample size (number of cases or images) used for these test sets. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that the device uses scans from Siemens SOMATOM Definition Flash and SOMATOM Force scanners and was tested with both normal perfusion data (non-shuttle mode) and shuttle mode 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 specific qualifications. The regulatory submission primarily focuses on the technical verification and validation of the software itself rather than clinical validation with expert-derived ground truth.

4. Adjudication Method for the Test Set:

No information regarding an adjudication method (such as 2+1 or 3+1) is provided in the document for any test set. The submission focuses on software testing against its specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This type of clinical study is not detailed in this 510(k) submission, which primarily focuses on substantial equivalence based on technical and performance characteristics comparison to a predicate device.

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

The document states, "syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data..." and "As syngo.CT Myocardial Perfusion is a post processing application only..." This suggests that the core functionality of generating perfusion maps and parameters is performed by the algorithm in a standalone manner. The "performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion," which would generally refer to testing the algorithm's output against expected results or specifications. However, specific details of a standalone performance study with quantitative metrics are not provided beyond the general statement of "verification and validation testing."

7. The Type of Ground Truth Used:

The document does not explicitly describe the type of ground truth used for any performance evaluation. Given the nature of a 510(k) for post-processing software, the "ground truth" for the verification and validation (V&V) testing would typically refer to:

• Known input-output relationships: Testing if the software accurately calculates parameters based on defined algorithms and synthetic or well-characterized real data where the expected output is known.
• Comparison to predicate device results: Ensuring the new software produces comparable results to the legally marketed predicate device for similar input data.
• Scientific literature/published models: Conformance to established scientific models for perfusion calculation.

No mention of expert consensus, pathology, or outcomes data being used as ground truth is present in the provided text.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. As a post-processing software application, syngo.CT Myocardial Perfusion is described as utilizing deconvolution and Tofts' models for parameter calculation. This implies that the software is based on established mathematical models and algorithms, rather than a machine learning model that would require a distinct "training set" in the conventional sense. The development likely involved algorithmic optimization and software engineering rather than deep learning model training.

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

Since the document does not indicate the use of a "training set" for a machine learning model, it also does not describe how ground truth for such a set was established. The software's underlying algorithms (deconvolution, Tofts' model) are likely validated through theoretical correctness and empirical testing against known physical models or data with pre-calculated expected outputs.

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syngo.CT Dental is post processing image analysis software for CT volume data sets that has been acquired continuously with computed tomography (CT) systems. The software provides the following digital image processing and visualization tools:

Basic reading tools: Multiplanar Reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT), Minimal Intensity Projection (MinIP)

Basic geometric measurement tools: distance line, polyline, marker, arrow, angle

Basic HU measurement tools: Pixel lens, ROI Circle, ROI freehand, VOI sphere, VOI freehand Dedicated dental visualization tools: Dental panoramic views (curved MPRs) and dental paraxial views (cross-section MPRs) that are calculated based on a manually defined centerline.

A tool to manually outline the mandibular canal.

A tool that allows paraxial and panoramic result images to be saved as dental range series.

True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its actual size on the film sheet.

The specific visualization of panoramic and paraxial views of the dental structures facilitates viewing, manual identification, and marking of dental pathologies and anatomy (for example, the position of the mandibular canal that needs to be preserved during dental interventions, such as dental (implant) surgery). Reporting and documentation of results is facilitated by the creation of ranges and snapshots, True Size (1:1) printing on DICOM printers, and by the use of a reporting tool.

syngo.CT Dental is post-processing image analysis software for computed tomography volume data sets that combines basic and advanced visualization that can be used in pre-surgical planning for dental operations, such as the planning of dental implant surgery. syngo.CT Dental contains image processing tools that allow for easy viewing and manual identification and marking of dental anatomy and pathologies by a physician.

The provided text describes the syngo.CT Dental software, a post-processing image analysis tool for CT scan data. It details the modifications made to a previously cleared predicate device and the testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria for each feature (e.g., a specific percentage accuracy for a measurement tool). Instead, it states that "The test results show that all of the software specifications have met the acceptance criteria" and "The testing results support that all of the software specifications have met the acceptance criteria."

The reported device performance is described in terms of functionality and successful verification and validation:

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

• Sample Size: The document does not specify the sample size used for the test set. It mentions "Integration and functional tests were conducted" and "Performance tests were conducted," but provides no numbers of cases or datasets tested.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method:

• Adjudication Method: Not specified. The document does not mention any form of adjudication for establishing ground truth.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the software's functionality and safety modifications, comparing it to a predicate device rather than evaluating human reader performance with and without AI assistance.

6. Standalone Performance Study:

• Standalone Study: Yes, a standalone performance study was conducted. The "Nonclinical Testing" section states, "Nonclinical tests were conducted for syngo.CT Dental during product development. The modifications described in this premarket notification were supported with verification and validation testing." "Performance tests were conducted to test the functionality of the subject device, syngo.CT Dental." This indicates direct testing of the algorithm's performance.

7. Type of Ground Truth Used:

• Type of Ground Truth: The document does not explicitly state the type of ground truth used. Given that syngo.CT Dental is a post-processing image analysis software with tools for visualization, measurement, and identification, the ground truth would likely involve expert consensus or reference measurements based on the CT image data itself for features like mandibular canal outlining, measurement accuracy, and proper rendering of dental structures. Pathology or outcomes data are not indicated as the primary ground truth for this type of image analysis software.

8. Sample Size for the Training Set:

• Sample Size: Not specified. The document focuses on verification and validation testing of the product, not its development or training process.

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

• Ground Truth for Training Set: Not specified. The document does not describe the training set or how its ground truth was established.

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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 data sets. 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 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 of examinations and followup 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 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. 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.

The modifications to the syngo.via MI Workflows (K123577) is adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment. This change is based on current commercially available software features and does not change the technological characteristics of the device.

syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

The provided text (K133644, Siemens Medical Solutions USA, Inc., syngo.via MI Workflows) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use but** does not contain information about acceptance criteria, specific studies, or performance metrics in the way requested.**

The document states that the modification to the previously cleared syngo.via MI Workflows (K123577) is "adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment." It also notes that this change "does not change the technological characteristics of the device" and that "no changes that raise any new issues of safety and effectiveness as compared to the predicate device."

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions relating to specific acceptance criteria, study details, and performance results.

However, I can extract information related to the device and its general validation:

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

No specific study is described in detail within these documents. The information provided discusses verification and validation activities generally, but not a specific clinical or performance study with defined acceptance criteria and performance results directly linked to the SUV harmonization feature.

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 states "Verification and Validation activities have been successfully performed" but does not detail sample sizes, data provenance, or whether the testing 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)

• Not provided.

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. The document focuses on the software's functional capabilities (SUV harmonization) and its substantial equivalence, not on comparative effectiveness studies involving human readers.

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

• Given the nature of the device as "Image Processing Software" that "provide analytical tools to help the user assess, and document changes," it is inherently a human-in-the-loop device. No standalone performance metrics are provided or implied for automated decision-making without a clinician. The "Note" in the Indications for Use explicitly states: "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."

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

• Not provided. The document does not describe the specific ground truth methodologies used for its "Verification and Validation activities."

8. The sample size for the training set

• Not provided. The document describes a software modification to an existing product and does not indicate details about machine learning model training.

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

• Not applicable / Not provided. As no training set details are mentioned, the method for establishing its ground truth is also not provided.

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syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features.

syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.

syngo.Breast Care is a software application dedicated to the special needs in breast cancer detection and assessment. syngo.Breast Care consists of several software engines, syngo.Breast Care Reading, syngo.Breast Care CAD Display and syngo.Breast Care Tomo, all based on the syngo.Breast Care Reading module.

syngo.Breast Care is an optional application for syngo.via VA20 (K123375 cleared on November 20, 2012). Syngo.via (a Siemens product) offers multimodality applications and feature sets to support customers in diagnostic imaging for various clinical areas (e.g. general Radiology, Cardiology, Oncology, Neurology, Orthopedics and Women's Health's). Additionally to a multi-client installation, synqo.Breast Care may also be configured with syngo.via as a single workplace.

The provided 510(k) summary for Siemens syngo.Breast Care Software does not contain the detailed information necessary to fully answer all of the questions regarding acceptance criteria and the study proving device performance. The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data.

Here's what can be extracted and what is missing, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, workflow efficiency targets). The document focuses on demonstrating substantial equivalence to the predicate "MammoReportPlus" and mentions general safety and effectiveness.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, reading time reduction) are reported for the syngo.Breast Care software. The document states that the user interface and workflow are "optimized to support experienced mammography and tomosynthesis reviewers" and that "Efficiency and reading quality are supported by various specialized features," but no quantitative data is provided to back these claims in the context of acceptance criteria.

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

• This information is not provided in the 510(k) summary. The document does not describe a specific clinical study with a test set of images.

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)

• This information is not provided in the 510(k) summary, as no specific test set and ground truth establishment process are detailed.

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

• This information is not provided in the 510(k) summary, as no specific test set and adjudication process are detailed.

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

• This information is not provided in the 510(k) summary. The document does not mention any MRMC study comparing human readers with and without AI assistance. The syngo.Breast Care software is described as providing "visualization and image enhancement tools to aid a qualified radiologist," implying human-in-the-loop, but no comparative effectiveness data is presented.

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

• This information is not provided in the 510(k) summary. The device's description and indications for use explicitly state that it "provides visualization and image enhancement tools to aid a qualified radiologist in the review," and "The radiologist is responsible for making the diagnosis," indicating it's not a standalone diagnostic algorithm.

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

• This information is not provided, as no specific study data or ground truth establishment process is detailed.

8. The sample size for the training set

• This information is not provided. The document does not describe the development or training of any AI or CAD component that would require a training set. The device is primarily a software review environment with image enhancement tools.

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

• This information is not provided, as no training set or ground truth establishment for it is mentioned.

Summary of what the document does state regarding acceptance and equivalence:

The 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device, "MammoReportPlus" (K042868).

• Intended Use Equivalence: syngo.Breast Care has a "similar intended use" to the predicate. Both are described as dedicated softcopy review environments for mammography and digital breast tomosynthesis, aiding radiologists in diagnosis.
• Technological Equivalence (with differences): syngo.Breast Care is a "software only solution to run on compatible client server environment together with monitor displays cleared for Mammography," whereas the predicate was a "complete hardware and software package." An optional module for tomosynthesis display is also noted for the subject device.
• Safety and Effectiveness Concerns: The document states that "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner." It also mentions "Several safety features including visual and audible warnings are incorporated into the system design" and that "the syngo.Breast Care is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed." This broadly implies that the safety and effectiveness are established through design controls and comparison to the predicate, rather than by a specific performance study with explicit acceptance criteria.

In conclusion, this 510(k) summary does not contain the detailed clinical study information, specific acceptance criteria, or quantitative performance metrics typically found in a clinical study report. Its purpose is to demonstrate substantial equivalence based on intended use and technological characteristics to a predicate device, as required for 510(k) clearance.

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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 support the interpretation and evaluation 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 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 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. 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 morpholoqical 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 synqo.via MI Workflows (K113029) are adding enhanced functionality to the commercially available Oncology workflow in this software. All changes are based on current commercially available software features and do not change the technological characteristics of the device.

syngo.via MI Workflows are intended to be run on the Siemens synqo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

The provided text is a 510(k) Premarket Notification for the Siemens syngo.via MI Workflows device. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device (K113029).

However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on:

• Identification of the Submitter and Product
• Marketed Devices to which Equivalence is claimed (predicate device)
• Device Description: What the software does (viewing, manipulation, 3D visualization, comparison of medical images from multiple modalities and time-points, support for functional and anatomical data, analytical tools for assessment and documentation of changes).
• Safety and Effectiveness: Mentions compliance with ISO 14971:2007 for risk management, ISO 13485 and IEC 62304 for development, and that "Verification and Validation activities have been successfully performed."
• Indications for Use: Reiterates the device's functionality and its role as a complement to clinician diagnosis.
• Conclusions: States substantial equivalence to the predicate device and no new safety or effectiveness issues.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The document is a submission for regulatory clearance based on substantial equivalence to a predicate device, and thus typically does not include detailed performance studies with acceptance criteria in the summary provided. Such details would usually be found in the comprehensive technical documentation submitted to the FDA, but not necessarily in the publicly available 510(k) summary.

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syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. The predicate device, syngo.via allows for the use of a variety of advanced applications (clinical applications) These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:

This 510(k) pertains to "syngo.via," a PACS system. Based on the document, this 510(k) is for enhanced functionalities of syngo.via, making it an update or extension of a previously cleared device (K123375). The key here is that it's not a new AI algorithm designed for a
specific diagnostic task with associated performance metrics. Instead, it seems to be primarily a software platform update that integrates functionalities already present in other cleared Siemens products.

Therefore, the typical structure for reporting AI/CADe/CADx device performance (sensitivity, specificity, AUROC, etc.) involving a test set, ground truth, and expert readers is not applicable in this submission. The "acceptance criteria" discussed are likely related to software verification and validation, adherence to standards, and demonstrating substantial equivalence to existing devices with similar functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, this 510(k) is for an enhanced PACS system and does not present specific diagnostic performance metrics. The "performance" is primarily demonstrated through compliance with standards and equivalence to predicate devices. There are no explicit quantitative acceptance criteria for diagnostic performance in terms of sensitivity, specificity, etc., as it's not a new diagnostic algorithm.

The "performance" described is in terms of:

• Software Functionality: Viewing, manipulation, communication, and storage of medical images.
• Integration: HL7-/DICOM-compatible RIS workflow.
• Technological Characteristics: Runs on Windows OS, supports DICOM images, image data compression (lossless and lossy).
• Imaging Algorithms (inherited/similar to predicates): MPR, MIP, MinIP, VRT, SSD, Digitally Reconstructed Radiograph, Editor functionality, Registration, Region Growing, Quantitative measurements.
• Automatic Spine Labeling (inherited/similar to predicates): Anatomy Labeling of Vertebra bodies, automatically suggested labels with manual override.

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

The document does not describe a "test set" in the context of diagnostic performance evaluation (e.g., a set of medical images used to evaluate an algorithm's diagnostic accuracy). The testing performed was software verification and validation testing at Unit, Integration, and System levels, as per IEC 62304. This type of testing uses various software inputs and configurations to ensure functional correctness, rather than a diagnostic image dataset. No specific sample size of images or data provenance (country, retrospective/prospective) is provided because it's not relevant for this type of submission.

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

Not applicable. There was no diagnostic "test set" requiring expert ground truth for diagnostic accuracy evaluation.

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

Not applicable. There was no diagnostic "test set" requiring expert ground truth or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This 510(k) does not present an MRMC study comparing human reader performance with and without AI assistance, as it is a PACS system enhancement, not a new AI-powered diagnostic tool.

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

Not applicable. This is not a standalone diagnostic algorithm. syngo.via is a platform for viewing, manipulation, communication, and storage of medical images, intended to "support the physician in diagnosis and treatment planning." The functionalities described (like automatic spine labeling) are features within this broader platform, and their performance is indicated as being similar to those from previously cleared predicate devices.

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

Not applicable. As there was no diagnostic test set in the traditional sense, there was no ground truth for diagnostic accuracy established through expert consensus, pathology, or outcomes data. The "ground truth" for the software's functional performance would be defined by the software requirements and design specifications, verified through testing procedures.

8. The sample size for the training set

Not applicable. This 510(k) does not describe a new AI algorithm that requires a training set. The enhanced functionalities are stated to have "similar technological characteristics as the predicate device" and incorporate "imaging and post processing algorithms compared to the above mentioned predicate devices." This implies that any underlying algorithms for features like "Automatic Spine Labeling" are either existing, well-established, or derived from components previously cleared, rather than newly developed and trained models.

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

Not applicable, as there is no mention of a training set for a new algorithm in this 510(k) submission.

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