(340 days)
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.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.