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The uMI Panorama is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.

This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The proposed device uMI Panorama combines a 280 or 350 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET system, CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories.

The PET system features the following specification and technologies.

• 760mm patient bore size.
• Scalable LYSO detector configurations (96-ring and 120-ring) to have scalable Axial Field of Views (AFOV) of 280 and 350mm respectively, with corresponding imaging performances.
• 318 kg maximum table load capacity allows flexible positioning and access for all patients.
• uExcel Iterative (also named HYPER Iterative, has been cleared in K193241), uses a regularized iterative reconstruction algorithm, which allows for more iterations while keeping the image noise at an acceptable level by incorporating a noise penalty term into the objective function.
• uExcel DPR (also named HYPER AiR, has been cleared in K210001), involves pre-trained neural networks in the iteration reconstruction process to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
• uExcel Focus (also named HYPER Focus, has been cleared in K210418), a respiratory motion correction feature can compromise respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.
  The CT system is UIH's 40mm detector uCT ATLAS Astound, which can also be used for standalone, diagnostic CT imaging.

The control and reconstruction system contains image acquisition and reconstruction. image display and post processing, data and patient management. CT dose display, networking, filming, etc.

I am sorry, but the provided text does not contain specific acceptance criteria, details of a clinical study demonstrating the device meets such criteria, or information on AI performance. The document is a 510(k) premarket notification summary for a medical device (uMI Panorama PET/CT system), primarily focused on proving substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. It lists general indications for use and performance data from non-clinical testing for electrical safety and electromagnetic compatibility, software, and biocompatibility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this specific information is not present in the provided text.

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