(274 days)
The Z-Robot™ Patient Positioning System is 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 Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.
The requested information is contained within the provided text. The device in question is the "Z-Robot™ Patient Positioning System", which is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a "table of acceptance criteria and reported device performance" for all tests. However, it lists the performance parameters tested and indicates that "All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report." It also provides a direct comparison to the predicate device for several key performance metrics, implying these are the relevant acceptance criteria for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate & "Same") | Reported Device Performance (Z-Robot™ Patient Positioning System) |
|---|---|---|
| Accuracy | ± 0.5 mm and ± 0.2° | ± 0.5 mm and ± 0.2° (Same as predicate) |
| Linear XYZ maximal medical speed | 10 cm/s | 10 cm/s (Same as predicate) |
| Linear XYZ maximum maintenance speed | 20 cm/s | 20 cm/s (Same as predicate) |
| Angular Yaw Pitch Roll maximum medical speed | 5 °/s | 5 °/s (Same as predicate) |
| Angular Yaw Pitch Roll maximum maintenance speed | 12 °/s | 12 °/s (Same as predicate) |
| Collision detection | Detection of a 150 N force | Detection of a 150 N force (Same as predicate) |
| "Overtravel" in case of emergency stop |
§ 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.