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Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of PET images.

The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of medical images. The application supports dynamic Rubidium - PET and 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 measures of myocardial perfusion over time, and provides tools for the Clinician to assess these results. The user may save the results.

The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease.

The provided text details the 510(k) summary for the syngoCirculation DynamicPET device but does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.

The document primarily focuses on:

• Device identification and classification.
• Claim of substantial equivalence to predicate devices (ImagenMD with ImagenQ, and Syngo® Circulation).
• A general device description and its intended use for visualization, assessment, and quantification of dynamic Rubidium-PET and Ammonia-PET images, with a focus on myocardial perfusion.
• A statement on safety and effectiveness, mentioning risk management in compliance with IEC/ISO 14971 and arguing that the device introduces no new safety concerns and is substantially the same as predicates.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can provide a summary based on the available information and highlight what is missing.

Acceptance Criteria and Device Performance Study for syngoCirculation DynamicPET

The provided 510(k) summary for the syngoCirculation DynamicPET device does not explicitly state specific acceptance criteria or provide details of a study designed to prove the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with defined metrics.

Given the information provided, specific performance metrics, sample sizes, ground truth establishment, or expert involvement for a dedicated performance study are not available. The safety and effectiveness statement relies on risk analysis (IEC/ISO 14971) and a claim of substantial equivalence to predicate devices, implying that its performance is considered comparable to already cleared devices.

Missing Information:

• No specific acceptance criteria are listed.
• No quantitative device performance metrics (e.g., accuracy, sensitivity, specificity for specific tasks) are reported.
• No details of a specific device performance study are provided (e.g., study design, objective, outcomes).

Summary of Available Information (and what's missing):

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated.
• Reported Device Performance: Not explicitly stated in quantitative terms. The document implies performance is substantially equivalent to predicate devices.

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

• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided.

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

• Number of Experts: Not provided.
• Expert Qualifications: Not provided.

4. Adjudication method for the test set

• Adjudication Method: 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

• MRMC Study: Not mentioned or detailed. The device is a "Picture archiving and communications system" and performs "quantitative measurements of tracer uptake over time." It's likely intended as a tool to aid clinicians, but an MRMC study demonstrating human reader improvement with the software is not described in this document.
• Effect Size of Improvement: Not applicable, as no MRMC study is detailed.

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

• Standalone Performance: Not mentioned or detailed. The device is described as "a software product intended for visualization, assessment and quantification" that "provides automatic and manual tools" for clinicians, suggesting it's a tool for human review rather than solely relying on standalone algorithmic output presented without human intervention in terms of performance evaluation.

7. The type of ground truth used

• Type of Ground Truth: Not specified, as no particular performance study with ground truth is described.

8. The sample size for the training set

• Sample Size (Training Set): Not provided.

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

• Ground Truth Establishment (Training Set): Not provided.

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