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syngo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D.

Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements.

Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT.

synqo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D.

Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements.

Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT

The provided text is a 510(k) summary for the Siemens syngo Neuro PBV CT. It describes the device's intended use and general safety and effectiveness, but it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the requested data points (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details).

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It states: "The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards." This is a general statement about safety and effectiveness, not a detailed study of diagnostic or clinical performance.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to fill in the table and answer the questions based only on the provided text, indicating where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified in the provided text.
• Data provenance: Not specified in the provided text (e.g., 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:

• Number of experts: Not specified in the provided text.
• Qualifications of experts: Not specified in the provided text.

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

• Not specified 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 specified or implied in the provided text. The document is for a post-processing application, not specifically an AI-assisted diagnostic tool, and no comparative effectiveness study with human readers is mentioned.

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

• The text describes the device as a "dedicated post-processing application" that "calculates a volume" and "measures in 3D," which implies a standalone algorithmic function. However, no specific study detailing its standalone performance (e.g., against a ground truth without human intervention) is presented in this summary. The focus is on its technical function rather than diagnostic performance metrics.

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

• Not specified in the provided text.

8. The sample size for the training set:

• Not specified in the provided text.

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

• Not specified in the provided text.

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