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The nTRAK Patient Positioning and Monitoring System is Intended for use with a linear accelerator in Radiation Therapy(RT)/ stereotactic Radiosurgery(RS) to position a patient relative to the isocenter of the linear accelerator and to monitor the patient's location relative to that position.

The Navigator System utilizes a high resolution optical tracking system to determine and monitor the position of optical markers attached to the patient as the means to locate and monitor the position and orientation of the patient, relative to treatment isocenter. The Navigator System consists of the following major components: a. A high resolution optical camera array and illuminator. b. A computer workstation. c. An optical positioning device. d. An optical calibration device.

Based on the provided text, there is no information available regarding specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters requested.

The document is a 510(k) summary for a medical device (Navigator Patient Head/Neck Positioning and Position Monitoring System), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria.

Here's why the requested information cannot be provided from the given text:

• No Acceptance Criteria or Device Performance: The document explicitly states under "Performance Standards" that "Performance standards for this type of system have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic act." This indicates there are no official, pre-defined quantitative acceptance criteria discussed or met in this submission.
• No Study Details: The summary does not describe any specific performance study with a test set, ground truth, expert involvement, or sample sizes. The substantial equivalence is established by "comparison of functions and features and the use of an essentially identical optical position location device from the same commercial manufacturer," not by a detailed performance study.
• No Mention of AI or MRMC: The device description does not involve artificial intelligence, and therefore an MRMC comparative effectiveness study with AI assistance is not mentioned or relevant to this submission.
• No Standalone Performance: Since no studies are described, there is no mention of standalone (algorithm-only) performance.
• No Training Set Information: There is no discussion of a training set, as the submission relies on substantial equivalence.

Therefore, the table and other requested details cannot be populated from the provided text. The document is primarily a regulatory filing demonstrating equivalence, not a scientific publication detailing performance evaluation.

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