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Use of the ViewRay™ Treatment Planning and Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

The ViewRay™ Treatment Planning and Delivery System (TPDS) provides tools for planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. It is a computer-based device used by trained medical professionals. The Treatment Planning software is only designed to be used on the ViewRay radiation therapy system. The ViewRay TPDS is capable of assisting clinicians in reviewing, prescribing, tracking, and correcting the course of patient treatment using tools for contouring, visualization, data storage, anatomical target monitoring and reoptimization.

The provided text is a 510(k) Summary and related FDA correspondence for the ViewRay™ Treatment Planning and Delivery System. This document focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and technological characteristics.

Crucially, the provided text DOES NOT contain information about acceptance criteria, the specific studies performed to meet those criteria, device performance metrics, sample sizes for training or testing, ground truth establishment, or any detailed comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the given input. The 510(k) summary generally describes the device and claims substantial equivalence, but it does not detail specific validation studies that would include the requested information.

The document indicates:

• Predicate Device: Varian Medical Systems' Trilogy Mx™ System (K092871) and Eclipse™ Treatment Planning System (K091492).
• Intended Use: Planning and delivery of external gamma beam stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
• Technological Characteristics: Similar to the predicate devices with "minor differences."
• Standards Conformance: Designed to conform with applicable sections of IEC 60601-1, IEC 60601-2-11, IEC 62083, and IEC 61217.

To answer your questions, specific validation study reports, which are typically separate from the 510(k) summary, would be required.

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