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The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.

It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.

The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).

The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes.

It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles.

The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).

The provided document is an FDA 510(k) clearance letter for the "Qfix Radiotherapy Chair". It does not contain information about the acceptance criteria and study proving device performance as typically expected for software or AI/ML devices. This document is a regulatory approval for a physical medical device, not a software algorithm.

Therefore, I cannot answer your specific questions about acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided text. The document primarily focuses on FDA's determination of substantial equivalence for a physical radiotherapy support and fixation device.

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