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Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. Background: The procurement is to support regulatory science tools development for the Interventional, Radiological Imaging and Visualization regulatory science research program. Developing measurement methodologies for technical performance is critical for consistent evaluation of head mounted displays and image registration in interventional procedures. Specifically, the procurement for a robotic arm to precisely control the position and orientation of surgical tools to quantitatively characterize the spatial and temporal stability and accuracy of image registration. In addition, the robotic arm will also allow for controlled movement of an augmented and virtual reality head mounted displays (HMDs) or camera system to evaluate registration performance visualized through the HMD including simulated user movement. These types of technologies are increasingly being incorporated in medical devices across OPEQ. The range of motion of the robotic arm will allow for developing image registration regulatory science tools for a wider range of device types with more complex motions than are achievable with a linear translation stage. Finally, the robot will allow for greater flexibility in targets and cameras for characterizing registration using HMDs. This will align the Office of Science and Engineering Laboratories (OSEL) instrumentation with FDA recognized standards, such as the Instrumental Commission (IEC), for head mounted displays, which is essential for the OSEL mission of developing regulatory science tools. The collaborative robotic arm will be incorporated into an existing bench setup using custom developed software for controlling a collaborative robotic arm. Minimum Performance Requirements: Item 1: Collaborative Robotic Arm • Degrees of Freedom: 6 rotating joints • Payload: 5-10kg • Reach: 750-950 mm • Tool Movement at Tool Center Point (TCP) TCP location: Should support both TCP locations 100-200mm from center of face-plate on tool z-axis (along rotation axis of joint 6) 100-200mm from center of face-plate on the tool x-axis (orthogonal to rotation axis of joint 6). Range of TCP movement (position and orientation): X: at least 150mm Y: at least 150mm Z: at least 150mm Yaw angle: at least +/- 45o Pitch angle: at least +/- 45o Roll angle: at least +/- 20o • Maximum speed per joint: at least 180o/s • Maximum TCP velocity: at least 0.5 m/s • Joint movable range: Minimum rotation angle of each joint of all six joints must be more than 220o. • Position detection: encoders • Brakes mechanism that locks and unlock joint, including in an emergency and by user request. • Repeatability: less tha…
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