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The VISERA ELITE II Infrared Imaging System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. The VISERA ELITE II Infrared Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the VISERA ELITE II Infrared Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

[VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200]
This video system center is intended to be used with OLYMPUS camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

[VISERA ELITE II XENON LIGHT SOURCE OLYMPUS CLV-S200-IR]
The light source has been designed to be used with Olympus endoscopes, video system centers, light guide cables, and other ancillary equipment for endoscopic observation through visible and near-infrared fluorescence imaging with fluorescence agent.

[HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EA]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EB]
The camera head has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

[TELESCOPE IR/ULTRA WAIR500A,WAIR530A,WAIR100A,WAIR130A]
These endoscopes are intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal natural orifice surgery. In combination with a compatible infrared imaging system, the telescope allows for fluorescence imaging.

The subject devices OTV-S200, CH-S200-XZ-EA, and CH-S200-XZ-EB were cleared in 510(k) K190449. After clearances, no technological modification for the subject devices were made. Therefore, the above devices have been omitted from the device description in this pre-market notification.

CLV-S200-IR: This device consists of the source circuit, the control circuit, the illumination lamp, and the optical filter. The control circuit connects to the diaphragm to regulate the light intensity, the source circuit supplies the power to the illumination lamp, the operation panel and the rear panel. By switching on the illumination lamp, this device provides the light for endoscopic observation. This device regulates the endoscopic image brightness constantly from the video system center. The observation mode can be switched by the optical filter extracting the specific wavelengths.

WAIR100A, WAIR130A, WAIR500A, WAIR530A: The "IR" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "IR" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before the first and each subsequent use of the device, it must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "IR" Telescopes are available with different directions of view to allow use for various applications in accordance with the intended use as submitted with this 510(k).

This document describes the VISERA ELITE II Infrared Imaging System components (Xenon Light Source, Telescopes, Video System Center, and Camera Heads). There is no explicit "device" (like an AI algorithm) for which acceptance criteria and a study proving the device meets those criteria are directly provided in the format you described.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device meets specific performance acceptance criteria for a new function. Therefore, much of the requested information regarding an AI study or specific performance metrics linked to acceptance criteria is not present.

However, I can extract information related to the device's validation and compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several types of performance testing and compliance with standards. It does not provide a table with quantitative acceptance criteria and corresponding reported performance values for a specific device feature that would typically be seen in an AI performance study (e.g., sensitivity, specificity for disease detection). Instead, it lists validation activities.

The subsequent points (2-9) are generally applicable to studies for AI/CADe devices and are not fully addressed by this document, which pertains to a general surgical imaging system rather than a specific AI-driven diagnostic or assistive tool.

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

• Test Set Sample Size: Not applicable. The document describes an animal study but does not specify a "test set" in the context of an AI algorithm evaluation. For the animal study, it mentions "canines and swines" but does not give a specific number of animals.
• Data Provenance: The animal study involved "canines and swines." It's a prospective study as it involved taking videos to validate performance. Country of origin is not specified.

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

• For the animal study videos, evaluation was done by an "independent Health Care Professional." The number of professionals and their specific qualifications (e.g., radiologist with X years of experience) are not detailed.

4. Adjudication method for the test set:

• Not specified. It only mentions evaluation by "an independent Health Care Professional."

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:

• No MRMC or comparative effectiveness study involving human readers with and without AI assistance was described. This document is not for an AI-assisted device in that context.

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

• Not applicable. This device is an imaging system, not an AI algorithm. Its performance is demonstrated as an imaging tool used by surgeons.

7. The type of ground truth used:

• For the animal study, the "ground truth" for demonstrating substantial equivalence in IR observation was based on the performance observed and evaluated by a healthcare professional in a simulated body environment. This is closer to expert assessment/observation in a controlled animal setting, rather than pathology or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary:

This 510(k) pertains to an endoscopic imaging system. It demonstrates substantial equivalence to predicate devices through various engineering, safety, and limited performance tests (bench and animal study). It does not involve a software-based AI algorithm for image interpretation or diagnosis that would typically require validation against a test set with established ground truth by multiple experts. Therefore, many of the requested points related to AI device evaluation are not applicable or cannot be extracted from this document.

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