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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 databases of normal patients and normal parameters derived from these databases, derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Scenium VE10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VE10 consists of three workflows:

• Database Comparison
• Ratio 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 made to the Scenium VE10 software (K162339) to create the Scenium VE20 software include:

• The ability to create and support normal databases in the Striatal Analysis workflow
  • DaTSCAN-SPECT normals database
• Improvements related to the analysis screen for reporting in Striatal Analysis

In addition, workflow structures changed within the VE20 release. Previously, the three workflows (Database Comparison, Ratio Analysis, and Subtraction) encompassed the Scenium software. Ratio Analysis has since been split into two separate workflows. Now, the following four workflows exist within Scenium VE20:

• Database Comparison
• Striatal Analysis
• Cortical Analysis
• Subtraction

These changes are based on current commercially available software features and do not change the technological characteristics of the device.

Scenium VE20 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).

The provided text is a 510(k) summary for the Scenium VE20 device, which is an image processing software for PET and SPECT scans. It primarily focuses on demonstrating substantial equivalence to a predicate device (Scenium VE10) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the VE20 device itself.

Therefore, the document does not contain the detailed information required to fill out all sections of your request about acceptance criteria and a specific study proving the device meets them. The text states that "All testing has met the predetermined acceptance values" but does not elaborate on what those values were or what performance metrics were used to determine them for the Scenium VE20 specifically.

Here's what can be extracted and inferred, along with the information that is explicitly missing:

Acceptance Criteria and Reported Device Performance

Study Details Provided

The document refers to "Verification and Validation activities" and "All testing" but does not describe a specific clinical or technical study designed to prove the device meets explicit acceptance criteria in the way a clinical trial or performance study would. Instead, it relies on demonstrating equivalence to an already cleared device.

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

   • Not explicitly stated for Scenium VE20. The document does not describe a separate clinical test set or its sample size.
   • Data provenance: Not mentioned.

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

   • Not applicable / Not stated. No specific external "test set" and associated ground truth establishment process is described in this document for the Scenium VE20.

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

   • Not applicable / Not stated. No specific external "test set" and adjudication process is described.

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:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described as part of this 510(k) submission. The device (Scenium VE20) is primarily an image processing software for quantification and comparison, aiding clinicians, but the submission doesn't present it as an AI assistant in the typical sense that would necessitate an MRMC study comparing human performance with and without its aid. The improvements are related to expanding database and analysis capabilities.

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

   • Not explicitly described. The document states "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..." This implies internal testing of the algorithm's functions, but details of a formal "standalone" performance study are not provided. The device "aids the clinician" and its output facilitates "comparison," implying human interpretation remains central.

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

   • Not explicitly stated. Given the nature of the software (quantification and comparison with normal databases), the ground truth for the underlying databases (FDG-PET, amyloid-PET, and SPECT studies, DaTSCAN-SPECT normals database) would likely have been established through clinical diagnosis, expert consensus, or follow-up outcomes, but this is not detailed in the context of VE20's "testing."

7. The sample size for the training set:

   • Not explicitly stated for the Scenium VE20's development. The document mentions the "ability to create and support normal databases in the Striatal Analysis workflow" including a "DaTSCAN-SPECT normals database." The size and composition of these "normal databases" are not specified as "training sets" for a deep learning model, as the document doesn't explicitly state the use of AI/deep learning in the typical sense for image interpretation. This sounds more like statistical comparison to pre-existing normal population data.

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

   • Not explicitly stated for the Scenium VE20's development. For the normal databases, the ground truth would inherently be "normal patients" (as described in the text "existing databases of normal patients"). How the "normal" status was confirmed for these patients in these databases is not elaborated upon in this submission.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device by highlighting that the modifications do not alter the fundamental technological characteristics or intended use, and that internal verification and validation activities confirmed the software functions as designed and met its requirements. It does not provide the kind of detailed performance study and acceptance criteria that might be found in submissions for novel AI-powered diagnostic devices.

Ask a specific question about this device

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 FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Scenium VD20 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VD20 consists of three workflows:

• Database Comparison -
• -Ratio 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 made to the Scenium VD20 software (K150192) to create the Scenium VE10 software include:

• Enabled comparative quantification between Scenium workflows -
• User interface and usability improvements to improve consistency with the syngo.via platform
• Addition of new normal databases to the Database Comparison workflow
  • o SPECT HMPAO (Chang AC) normal database
  • PET Florbetaben normal database o
• -Stereotactic Surface Projection (SSP) for Amyloid uptake images can now be viewed

These changes are based on current commercially available software features and do not change the technological characteristics of the device.

Scenium VE10 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).

The provided text describes the regulatory clearance for the "Scenium VE10 Software" to be marketed as substantially equivalent to a predicate device. While it mentions "Performance Testing / Safety and Effectiveness" and that "All testing has met the predetermined acceptance values," it does not provide the specific details regarding the acceptance criteria, the study design, or the results that would allow for a comprehensive answer to your request.

Specifically, the document states:

• "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 about the completion of testing and meeting acceptance values, but it lacks the actual criteria and reported performance.

Therefore, I cannot provide the detailed information you requested, such as:

1. A table of acceptance criteria and the reported device performance: The document does not specify these.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, and the primary purpose of the software is described as aiding clinicians in assessment and quantification, implying it's a tool for human readers, but no MRMC study details are provided.
6. If a standalone (algorithm only) performance was done: Not explicitly stated with outcomes. The software performs "automated analysis through quantification of mean pixel values located within standard regions of interest," which implies standalone processing, but performance metrics for this are not given.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device (Scenium VD20 software, K150192) based on minor changes to the software (enabled comparative quantification, UI improvements, addition of new normal databases, and viewing SSP for Amyloid uptake images). It implies that the underlying technology and functionalities for aiding interpretation were already established with the predicate device.

To answer your questions, one would typically need access to the full 510(k) submission, which would contain the detailed studies and performance data. This document is a summary of the FDA's decision, not the full submission itself.

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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 FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Scenium VD10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VD10 consists of three workflows:

• Database Comparison
• Ratio Analysis
• Subtraction

These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies with different imaging agents, such as using Amyloid imaging agents for dementia and Alzheimer's Disease, DaTSCAN(1-123) for Parkinson's Disease and FDG-PET for epileptic seizures.

The modifications made to the Scenium VD10 software (K133654) to create the Scenium VD20 software include:

• Customized databases can now be imported and exported in the Database Comparison workflow.
• Three new FDG databases normalized to the region of the cerebellum, in addition to whole brain, were added to the Database Comparison workflow.
• Deformable Registration for Amyloid PET has been integrated in the Ratio Analysis workflow with a different algorithm.
• Launch performance decreased the time taken to display patient data in the Ratio Analysis workflow.

This change is based on current commercially available software features and does not change the technological characteristics of the device.

Scenium VD20 Analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K133644) or commercially available Siemens scanners (e.g. symbia Intevo (K142006), Biograph mCT (K123737).

This document is a 510(k) premarket notification for the Scenium VD20 software. It claims substantial equivalence to the previously cleared Scenium VD10 software (K133654). The provided text does not include a detailed study proving the device meets specific acceptance criteria with reported performance metrics, expert qualifications, or detailed study methodologies. Instead, it focuses on demonstrating that the modifications introduced in Scenium VD20 do not alter the fundamental technological characteristics or indications for use compared to the predicate device, and thus do not raise new safety and effectiveness concerns.

Therefore, many of the requested details about acceptance criteria and a specific study are not present in this regulatory document.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All testing has met the predetermined acceptance values." This is a general statement and does not provide specific quantitative acceptance criteria or reported performance values.

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

• Sample Size for Test Set: Not specified. The document mentions "Verification and Validation activities" and "All testing," but does not detail the size of the dataset used for these tests.
• Data Provenance: Not specified. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document focuses on software changes and their implications, not on clinical validation involving human readers or expert consensus on a test set.

4. Adjudication Method:

• Not specified. Since details about expert review or test sets are missing, an adjudication method is also not mentioned.

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

• No, an MRMC comparative effectiveness study is not mentioned or described. The documentation focuses on demonstrating substantial equivalence based on technical modifications and internal verification/validation, not on comparing human reader performance with and without AI assistance for the new features.

6. Standalone (Algorithm Only) Performance Study:

• No specific standalone performance study with detailed metrics (e.g., sensitivity, specificity, accuracy) is presented in this document. The verification and validation activities likely included internal testing of the algorithms, but explicit results demonstrating standalone performance are absent. The device itself is described as "display and analysis software" intended to "aid the Clinician," implying it is a tool for human-in-the-loop use rather than a fully autonomous diagnostic algorithm.

7. Type of Ground Truth Used:

• Not specified. Given the focus on software modifications and features, the "ground truth" for the verification and validation tests would likely relate to the expected outputs of the algorithms, internal consistency, and comparison with previous versions, rather than a clinical ground truth like pathology or long-term outcomes data.

8. Sample Size for the Training Set:

• Not applicable / Not specified. This device is described as "display and analysis software" and the modifications are primarily related to database functionalities, workflow integration, and an algorithmic change for deformable registration. There is no indication that this update involved a machine learning model that required a specific "training set" in the conventional sense of deep learning or AI model development. The "new FDG databases" are likely pre-computed reference datasets, not training data for a learning algorithm within Scenium VD20 itself.

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

• Not applicable / Not specified. As there's no mention of a traditional training set for a new machine learning algorithm, there's no information on how a ground truth for such a set would have been established.

Summary of what the document focuses on instead:

The document primarily provides evidence for substantial equivalence to a predicate device (Scenium VD10, K133654) by stating that:

• The modifications (customized database import/export, new FDG databases, deformable registration algorithm change, improved launch performance) do not change the technological characteristics of the device.
• There are no differences in the Indications for Use.
• No new issues of safety and effectiveness are raised by the modifications.
• Risk Management (ISO 14971:2012) and adherence to industry standards (ISO 13485, IEC 62304) were followed.
• Verification and Validation activities were successfully performed, and "All testing has met the predetermined acceptance values." This last point is the closest to an "acceptance criterion" statement, though it lacks specificity.

Ask a specific question about this device

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 FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Scenium VD10 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium VD10 consists of three main workflows: Database Comparison Workflow, Ratio Analysis Workflow, and Subtraction Workflow. These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (ie. Alzheimer's), movement disorders (ie. Parkinson's), and seizure analysis (ie. Epilepsy).

The provided text states that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." However, it does not provide specific acceptance criteria or detailed results of the study that proves the device meets these criteria. It primarily focuses on the device description, indications for use, and a comparison to predicate devices for substantial equivalence.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the given document.

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

1. Table of acceptance criteria and the reported device performance

Explanation: The document generally states that performance and functional testing were conducted and that all requirements were met, but it does not list the specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide quantitative performance metrics for the device against these criteria.

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

• Sample size for the test set: Not specified.
• Data provenance: Not specified (country of origin, 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)

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

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

• Adjudication method: Not specified.

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

• MRMC study: Not mentioned or described. The document focuses on the device's ability to "aid the Clinician," suggesting it's a tool for assistance, but it does not quantify human reader improvement.
• Effect size: Not specified.

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

• Standalone performance: Not explicitly stated as a separate study with specific metrics. The device is described as "aids the Clinician" and "enabling automated analysis," which implies standalone functionality, but a dedicated standalone performance study with results is not detailed.

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

• Type of ground truth: Not specified.

8. The sample size for the training set

• Sample size for training set: Not specified.

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

• Ground truth for training set: Not specified.

Summary of available information regarding the study:

The document mentions that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." It also states that "risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and ISO 14971:2012 to identify and provide mitigation to potential hazards."

However, this summary does not contain the detailed study plan, methodology, or results that would typically be present to demonstrate how the device meets specific acceptance criteria in terms of accuracy, sensitivity, specificity, etc., with human-read or pathology-confirmed ground truth. The information provided is high-level and confirms that internal testing was done and deemed successful by the manufacturer, but lacks the granular details requested.

Ask a specific question about this device

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 FDG-PET, amyloid-PET, and SPECT studies and calculation of uptake ratios between regions of interest.

Scenium 3.0 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. Scenium 3.0 is post processing and does not control the scanning features of the system.

The provided text is a 510(k) summary for the Scenium 3.0 device. A 510(k) submission generally establishes substantial equivalence to a predicate device and does not typically involve the presentation of detailed acceptance criteria or extensive clinical studies in the same way a PMA submission might.

Based on the provided document, here's what can be inferred about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists no specific quantitative acceptance criteria or detailed device performance metrics in a tabular format. The submission focuses on demonstrating substantial equivalence to predicate devices (Scenium 2.0, NeuroTrans3D, Brass) rather than proving performance against predefined clinical thresholds.

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

The document does not specify any sample size used for a test set or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). This type of information would typically be detailed in a separate clinical or performance evaluation report, which is not part of this 510(k) summary.

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

The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The submission is based on the functional and technological equivalence of the Scenium 3.0 software to predicate devices for aiding clinicians in assessment and quantification, not on a new clinical claim requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1, none) is mentioned because the document does not describe a clinical test set that would require such a method.

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

The document does not describe an MRMC comparative effectiveness study or indicate an effect size for human readers improving with or without AI assistance. This type of study is more common for devices making claims about improving diagnostic accuracy or efficiency with AI. Scenium 3.0 is described as post-processing software that aids in analysis and quantification, implying it's a tool for clinicians rather than an AI-driven diagnostic system in the conventional sense that would undergo MRMC.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone performance study of the algorithm without human-in-the-loop performance. The device is presented as a tool to "aid the Clinician" and "facilitates comparison," indicating it's designed to be used in conjunction with human interpretation.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used as it does not detail a study that would necessitate it. The focus is on the software's ability to "enable automated analysis through quantification of mean pixel values located within standard regions of interest" and "facilitate comparison with existing scans," suggesting its functionality is related to data processing and visualization rather than a direct diagnostic output requiring a definitive ground truth.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. This is because the submission emphasizes the software's functionality and its substantial equivalence to predicate devices, not the development and validation of a new machine learning algorithm that would require a distinct training set.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Device and Evidence:

The Scenium 3.0 is a Picture Archiving and Communication System (PACS) and emission computed tomography system software. It's designed to aid clinicians in the assessment and quantification of pathologies from PET and SPECT brain scans by enabling automated analysis through quantification of mean pixel values in regions of interest and facilitating comparison with existing scans.

The study presented in the 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices (Scenium 2.0, NeuroTrans3D, Brass). The evidence provided focuses on:

• Indications for Use: The Scenium 3.0's indications are similar to those of the predicate devices, aiding clinicians in assessment and quantification of PET/SPECT brain scans.
• Technological Characteristics: The software is described as similar in uses and applications to the predicate devices, all assisting clinicians with visual evaluation, assessment, and quantification.
• Safety and Effectiveness: The device is stated to be designed and manufactured under Quality System Regulations (21 CFR 820) and complies with relevant standards (21 CFR 892.1200, 21 CFR 892.2050, ISO 14971, ISO 62304).

The acceptance criteria for a 510(k) submission like this are implicit: demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The study's "acceptance" is the FDA's clearance, indicating that Siemens Medical Solutions USA, Inc. successfully demonstrated substantial equivalence. Quantitative performance data, clinical study details, and expert adjudication are generally not required for this type of submission unless the new device introduces novel technology or makes new clinical claims that fall outside the scope of predicate devices.

Ask a specific question about this device

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 FDG-PET, amyloid-PET, and SPECT studies and calculation of uptake ratios between regions of interest.

Scenium 2.0 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.

Scenium 2.0 is post processing and does not control the scanning features of the system.

The provided text is a 510(k) Premarket Notification for Scenium 2.0. This document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available within this document. The 510(k) submission primarily relies on comparing the new device's technological characteristics, indications for use, and safety/effectiveness considerations to those of predicate devices.

Here's an analysis based on the available information:

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

Not available in the provided text. The document does not specify quantitative acceptance criteria or report specific performance metrics for Scenium 2.0. It primarily asserts that "All requirements of Emission Computed Tomography system standards (21 CFR 892.1200) and Picture Archiving and Communications System (21 CFR 892.2050) are met, and software is in compliance with ISO 14971 and ISO 62304." This is a statement of compliance with standards rather than specific performance data against acceptance criteria.

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

Not available in the provided text. No information on a specific test set, its size, or data provenance is mentioned.

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 available in the provided text. This information would typically be detailed in a separate clinical study report, which is not part of this 510(k) summary.

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

Not available 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

Not available in the provided text. The document describes Scenium 2.0 as "post processing" software that "aids the Clinician" and "enables automated analysis," suggesting it is a human-in-the-loop device. However, no MRMC study or its findings (effect size of improvement with AI assistance) are mentioned.

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

Not explicitly stated. Given the description of the software aiding clinicians and facilitating automated analysis, it's likely intended for human-in-the-loop use. Standalone performance, if assessed, is not reported in this document.

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

Not available in the provided text.

8. The sample size for the training set

Not available in the provided text. The document does not describe any machine learning model training.

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

Not available in the provided text.

Ask a specific question about this device

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 workstations 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 facilitating comparison with existing scans derived from FDG-PET and SPECT studies.

Scenium 1.1 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.

The software is post processing and does not control the scanning features of the system.

The provided text is a 510(k) summary for the Scenium 1.1 software and does not contain information about acceptance criteria or specific study results to prove device performance.

The document focuses on:

• Company contact details
• Identification of the product and its classification
• Comparison to predicate devices
• Device description
• Indications for Use
• Technological characteristics (stating similarity to predicate devices)
• Safety and effectiveness concerns (mentioning compliance with regulations and standards)
• A statement of substantial equivalence to predicate devices.
• The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information from the provided document.

The document generally asserts substantial equivalence based on similar uses, applications, and features to predicate devices, and compliance with regulatory standards (21 CFR § 820, 21 CFR 892.1200, 21 CFR 892.2050, and BS EN ISO 14971:2001). However, it does not present a specific study with defined acceptance criteria and corresponding performance metrics for the Scenium 1.1 software itself.

Ask a specific question about this device

Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised 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 facilitating comparison with existing scans derived from FDG-PET studies.

Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.

I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the Scenium device by Mirada Solutions Ltd., seeking clearance from the FDA. It mainly discusses:

• General company and contact information.
• Device description and its intended use (aid in assessment and quantification of pathologies from PET scans, particularly human brain scans using FDG-PET).
• Technological characteristics and safety/effectiveness concerns, stating compliance with quality system regulations and ISO 14971.
• A claim of substantial equivalence to predicate devices (NeuroQTM and GE Discovery ST).
• The FDA's letter of substantial equivalence determination, allowing the device to be marketed.
• The Indications for Use form.

While it mentions that "All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 820.1200 have been met," and the software is in compliance with ISO 14971, it does not provide a table of acceptance criteria nor a detailed study that reports device performance against such criteria. The document focuses on regulatory clearance via substantial equivalence, not a performance study per se.

Therefore, I cannot provide the requested table and study details based on the information given.

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