(141 days)
The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability.
The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.
The provided text is a 510(k) summary for the LEONI ORION System, an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested items related to AI device evaluation (like MRMC studies, ground truth establishment for training data, and expert qualifications) are not applicable or cannot be extracted from this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Payload Capacity | Not explicitly stated as "acceptance criteria" but tested. | 375 kg / 826 lbs |
| Accurate Treatment Volume | Not explicitly stated as "acceptance criteria" but tested. | 400 mm x 1000 mm x 500 mm |
| Accuracy | Not explicitly stated as "acceptance criteria" but tested. | ± 0.5 mm and ± 0.2° |
| Speed | Not explicitly stated as "acceptance criteria" but tested. | 0.1 m/s and 6 °/s |
| Safety (Collision Detection) | Not explicitly stated as "acceptance criteria" but tested (detection of a 150N force). | Detection of a 150N force |
| Safety ("Overtravel" in emergency stop) | Not explicitly stated as "acceptance criteria" but tested ( |
§ 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.