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The AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instrument guides are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.

The AQrate™ Robotic Assistance System is a medical robotic system with a robotic arm fixed to a mobile cart, hardware, and software. The system allows for accurate positioning of surqical instruments and screws during spinal surgery with the use of a robotic arm. The instruments may be navigated or tracked relative to the patient's anatomy on reconstructed images using the Medtronic StealthStation® System.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the AQrate Robotic Assistance System, which confirms its substantial equivalence to predicate devices based on technological characteristics, performance, and intended use.

While it mentions "Performance Testing" including "Non-clinical system, software, and instrument verification" and "Surgical simulations conducted on phantom models," it does not provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for any test set or data provenance.
3. Number and qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study details or effect sizes.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing ground truth for the training set.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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