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The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to acquire CT images and enable the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

The Marie System is intended to be used by healthcare professionals to image patients in an upright position rather than conventional supine treatments, to enable precise treatment planning and patient positioning for radiotherapy.

Specifically, it is intended to:

• Image the patient to provide image-guided radiation therapy
• Image the patient to acquire images for the purpose of treatment planning
• Immobilize patients in an upright position for upright radiotherapy.

The Marie System is comprised of two major sub-systems: a computed tomography (CT) imaging system that performs pretreatment imaging and treatment simulation in the upright positions and a beam agnostic, patient positioning system that supports the patient in the upright positions.

The Marie Imaging System is used with compatible devices for treatment delivery and patient immobilization. The positioning system is designed with six degrees of freedom of motion and a patient positioning system to provide the desired posture for each cancer site to achieve accurate, reproducible patient setups, while the imaging system acquires helical scans by translating and rotating up the patient.

The provided text solely describes the Leo Cancer Care Marie System as a Computed Tomography X-ray System with its features, safety, and performance details. It outlines the regulatory clearance (FDA 510(k)) based on substantial equivalence to a predicate device (P-ARTIS K160611). It describes the device's characteristics and the non-clinical tests performed to demonstrate its performance and functionality against design and risk management requirements.

Crucially, the provided text does not contain any information about acceptance criteria for AI performance, clinical study design, sample sizes for test or training sets, ground truth establishment using experts, or any MRMC comparative effectiveness studies. The document is a 510(k) clearance summary for a medical device (a CT imaging and patient positioning system), not for an AI diagnostic or assistive software. The "performance testing" section refers to hardware and software system performance, not AI model performance.

Therefore, I cannot answer most of your questions based on the provided input. The questions you've asked are typically relevant for AI/ML-based medical devices or diagnostics that involve image interpretation and require rigorous validation against human expert performance. The Marie System, as described, is a physical imaging system for patient positioning and CT image acquisition, not an AI software.

If this were an AI device, the answers would need to be extracted from sections detailing clinical performance studies, AI model validation, or similar. Since those sections are absent, I am unable to provide the requested information.

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The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.

The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments.

The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.

The provided text is an FDA 510(k) summary for the "Leo Cancer Care Eve Patient Positioner System." It describes a medical device used for patient positioning in radiation therapy.

However, this document DOES NOT describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML performance.

Instead, the document outlines the substantial equivalence of the Eve Patient Positioner System to a predicate device (LEONI Orion System K160518) based on non-clinical performance testing for device functionality and safety. The document states:

• "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." Therefore, there's no clinical study involving human readers or expert consensus for ground truth as would be relevant for an AI/ML device.
• The performance testing focuses on mechanical and electrical performance (e.g., accuracy of positioning, speed, patient load, motion axes, and compliance with general medical device and software life-cycle standards like ISO 14971, IEC 60601-1, IEC 62304).

Therefore, it is impossible to extract the requested information regarding AI/ML acceptance criteria, study details, human reader performance, or ground truth establishment relevant to an AI/ML algorithm from this document.

If you have a document describing an AI/ML powered medical device, please provide that.

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