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URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

The provided text is a 510(k) summary for the URUS System, a digital flexible ureteroscope. This document outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain details about a clinical study comparing the device's performance to specific acceptance criteria in a human cohort.

Instead, the performance data section primarily discusses bench testing, compliance with standards, and software validation. There is an explicit statement: "The subject of this premarket submission did not require clinical studies were considered necessary and performed." This means there won't be information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies that typically derive from clinical trials.

Therefore, I cannot fulfill all parts of your request as the provided document lacks a description of a clinical study that proves the device meets acceptance criteria defined by performance metrics like sensitivity, specificity, or reader improvement.

However, I can extract information related to the bench testing and other validations performed, which can be presented in a modified format to address the parts that are available.

Here's a summary based on the provided document:

Acceptance Criteria and Device Performance Study for the URUS System

The URUS System, a single-use digital flexible ureteroscope, underwent various types of testing, primarily bench testing, to demonstrate its performance and substantial equivalence to a predicate device (WiScope™ Digital Endoscope System, K181977). A clinical study was not considered necessary or performed for this premarket submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" for clinical performance (like sensitivity, specificity) and "reported device performance" against those in a clinical setting are not available from the provided document, I will present the performance items tested in bench studies, which serve as a form of acceptance criteria for engineering and optical performance.

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