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EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation. The primary components of the subject system, are: EVIS EXERA II Xenon Light Source Olympus CLV-180 and EVIS EXERA II Video System Center Olympus CV-180. The endoscope to be added for the system, is: VISERA Uretero-Reno Videoscope Olympus XURF type V.

The provided text is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM. It describes the device, its components, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, or expert adjudication that typically relate to the performance proof of a device.

This document focuses on demonstrating that the new device is "substantially equivalent" to existing legally marketed devices based on technological characteristics and intended use, rather than presenting a detailed clinical or performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to answer based on the available information, noting what isn't provided:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on comparing specifications to predicate devices to demonstrate substantial equivalence, not on specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. No specific test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. No ground truth establishment involving experts for a test set is mentioned.

4. Adjudication method for the test set

This information is not provided in the document. No adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This device is an endoscopic video imaging system, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study is not mentioned in the document. This device is a hardware system for image capture and processing, not an autonomous algorithm.

7. The type of ground truth used

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not provided in the document. There is no mention of a "training set" or ground truth establishment for such a set.

Summary of what the document does convey regarding "proof":

The "proof" for this device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on a standalone performance study against specific acceptance criteria. This is a common pathway for medical device clearance under 510(k).

• Comparison of Technological Characteristics: The document provides tables (Table 15-2, 15-3, and implied for the XURF-V) comparing the specifications of the subject devices (EVIS EXERA II 180 System components) to their predicate devices.
• Key Finding: The conclusion states: "When-compared to the predicate device, the EVIS EXERA II 180 System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device."
• NBI Feature: The key new feature, Narrow Band Imaging (NBI), is described as providing "greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes" when compared to conventional white light observation. However, no quantitative studies are presented to support this claim or define specific acceptance criteria for its performance.

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