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The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).

The provided text is a 510(k) summary for the WBR Xpress.PET device, which is an image processing system for PET/CT. It details the device's classification, predicate devices, description, and intended use, along with a statement on safety and effectiveness. The FDA's letter granting substantial equivalence is also included. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test or training sets, information about experts, adjudication methods, or MRMC study results.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in the provided document. The submitter's address is Haifa, Israel.

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 document.
• Qualifications of Experts: Not specified in the provided document.

4. Adjudication method for the test set

• Adjudication Method: Not specified in the provided document.

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 specified or implied in the provided document. The focus is on the device's technical equivalence in image reconstruction and correction, not on human reader performance improvement with AI assistance.

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

• Standalone Performance: The document states "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device." This implies an evaluation of the device's output, which is a standalone assessment of its image processing capabilities, but no further details on the study's design are provided.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. The comparison is made against "images that are reconstructed and ACSC corrected by predicate CT/PET device," suggesting the predicate device's output serves as a reference for "equivalence."

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the provided document.

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

• Ground Truth for Training Set: Not specified in the provided document. The document refers generally to "Bench and clinical data," but does not elaborate on how ground truth was established for any internal development or training purposes.

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