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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

2. Sample size used for the test set and the data provenance

The document describes bench tests rather than a "test set" in the context of diagnostic data. The tests were performed by LEONI, and some by a third-party test organization. The "data provenance" would refer to these test environments rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an electro-mechanical robotic arm, and the "ground truth" for its performance is determined by physical measurements and test procedures, not expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human reader studies, not to the performance testing of a robotic patient positioning system.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This document does not describe an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This document describes the performance of the device itself (standalone in terms of its mechanical and electrical function). The "algorithm only" concept is typically for diagnostic AI, which is not what this device is.

7. The type of ground truth used

The ground truth for the performance metrics (payload, accuracy, speed, safety) are based on physical measurements and engineering standards/specifications inherent to the design and function of a robotic arm, not medical outcomes, pathology, or expert consensus on medical conditions.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the machine learning sense. Its performance is based on engineering design, calibration, and physical testing.

9. How the ground truth for the training set was established

Not applicable, for the same reason as above.

Summary of the Study that Proves Acceptance Criteria:

The study proving the device meets its acceptance criteria involved a series of non-clinical bench tests. These tests were conducted by LEONI and third-party test organizations. The tests evaluated the physical and functional characteristics of the LEONI ORION System, including:

• Payload Capacity: Verified the maximum weight the system can support.
• Accurate Treatment Volume: Demonstrated the spatial envelope within which the specified accuracy can be maintained.
• Accuracy: Measured the precision of positioning (± 0.5 mm and ± 0.2°).
• Speed: Measured the maximum linear and rotational movement speeds (0.1 m/s and 6 °/s).
• Safety (Collision Detection): Tested the system's ability to detect a 150N force, indicating its safety mechanism.
• Safety ("Overtravel" in Emergency Stop): Verified that the system stops within a very short distance (< 5 mm) after an emergency stop, ensuring patient safety.
• Electromagnetic Compatibility (EMC): Confirmed compliance with relevant standards to prevent interference with other medical equipment.
• Electrical and Mechanical Safety: Ensured the device meets safety standards for electrical operation and mechanical integrity.

The document states: "The results from these performance assessments demonstrated that the LEONI ORION System met the acceptance criteria defined in the product specifications. Moreover these results proved that the subject device is comparable to the predicate device in terms of safety and effectiveness performance."

Therefore, the "study" was a series of engineering and safety tests designed to validate the mechanical and electrical specifications of the robotic positioning system, rather than a clinical study or an AI performance evaluation.

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