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ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.

This product does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to this product for diagnostic interpretation of mammographic images must be approved for use in digital mammography. All images sent to or imported into this product must conform to regulatory requirements. Image quality must conform to applicable quality guidelines.

ASPIRE Bellus II is medical application software with speedy image display and intelligent functions by image processing technologies. This application can support user to efficiently perform interpretation of examination images and make a diagnosis using various modality images and generate Mammography reports for diagnostic/screening purposes. ASPIRE Bellus II can receive various diagnostic images directly from image acquisition systems or PACS via network using DICOM protocol. Images are displayed on viewer monitors for doctors' review.

The provided document is a 510(k) premarket notification for the ASPIRE Bellus II device. It describes the device, its indications for use, comparison with predicate devices, and safety information. However, it explicitly states:

"The subject of this 510(k) notification, ASPIRE Bellus II did not require clinical studies to support safety and effectiveness of the software."

Therefore, the document does not contain any information regarding clinical studies, acceptance criteria, or reported device performance in the context of clinical outcomes or a specific task aided by AI. The notification focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance as a medical imaging software (PACS).

As a result, I cannot provide the requested table and information based on the given document because a study demonstrating the device meets acceptance criteria for a specific clinical task or AI performance was not conducted or reported in this 510(k) submission.

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