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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 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.

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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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