(116 days)
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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.