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The NIUINT at Fermilab NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

The modified NTS is a medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment. Modifications include upgrades to the Patient Treatment Chair Subsystem, the Patient Treatment Platform Subsystem, the GE CT/T 8800 Scanner Subsystem, and the Patient Treatment Simulation Software Subsystem.

This document is a 510(k) summary for a Neutron Therapy System (NTS) at Fermilab, submitted by Northern Illinois University Institute for Neutron Therapy. It concerns modifications to an existing preamendments medical device. The document does not contain any performance data relating to acceptance criteria or a study with specific metrics, sample sizes, or ground truth establishment for a novel device.

Instead, the submission states:

• Performance Data: "The modified NTS Patient Treatment Chair and Patient Treatment Platform Subsystems have been in clinical use for approximately two years. The GE CT/T 8800 Scanner Subsystem has been in clinical use for approximately five years and the Patient Treatment Simulation Software Subsystem has been in clinical use for approximately twenty-five years. All subsystems demonstrate that the post-1976 modifications meet performance specifications. Performance specifications and testing information are described in Sections XVIII-XX." (Page 1)

This indicates that the modifications were evaluated against pre-existing performance specifications for the subsystems themselves, which have been in clinical use for extended periods. The document highlights that the submission is about demonstrating substantial equivalence to a predicate device (a pre-1976 NTS), implying that the safety and effectiveness are established through the predicate and the long-standing clinical use of the modified subsystems, rather than a new clinical study with specific acceptance criteria as you've requested for a novel device.

Therefore, I cannot provide the requested information in the table format or answer the questions related to new device performance testing, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text. The document focuses on the regulatory framework of substantial equivalence for a modified preamendments device rather than a detailed performance study for a new device.

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