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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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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 CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ: These instruments have 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 r no ENET and The 100 - , monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.

The primary components of the subject system, which are part of this submission, are:

• EVIS EXERA 11 Xenon Light Source Olympus CLV-180, •
• EVIS EXERA II Video System Center Olympus CV-180, .
• VISERA Cysto-Nephro Videoscope Olympus CYF type V2, CYF type VA2, and XCYF . type VQ (hereinafter referred to as CYF-V2, CYF-VA2 and XCYF-VQ)

The EVIS EXERA II Xenon Light Source Olympus CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA II Video System Center Olympus CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-180 Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images, The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A. cleared under K051645 except that the device size has been slightly changed.

The CV-180 incorporates the following features:

1. The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
2. The CV-180 processes the NBI image, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

The provided document is a 510(k) summary for the OLYMPUS EVIS EXERA II 180 SYSTEM, which is an endoscopic video imaging system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and AI comparative effectiveness cannot be extracted from this document, as it describes a non-AI or CAD system. The document states that the new system is "basically identical to each predicate device ... in intended use, and similar in specifications, performance and materials" with the primary change being the addition of a Narrow Band Imaging (NBI) function, which is an optical filtering technique, not an AI/CAD algorithm.

However, I can extract the specific performance characteristics that are compared between the subject device and the predicate device, which can be seen as the "reported device performance" in the context of demonstrating substantial equivalence.

Here's the information that can be extracted, framed within your request as much as possible for a non-AI device:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for substantial equivalence of a medical device (endoscopic system) and not an AI/CAD system, "acceptance criteria" are implicitly defined by the device's technical specifications matching or being similar to those of the predicate device, and demonstrating safety and effectiveness for similar intended use. There are no explicit "acceptance criteria" for a specific performance metric in the way one would define for an AI algorithm's accuracy, sensitivity, or specificity. The "reported device performance" is essentially the detailed specifications of the subject device.

Rather than "acceptance criteria," the document presents a comparison of specifications to show similarity.

Table: Comparison of Specifications (Selected Examples)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the document. This is a traditional medical device submission based on technical specifications and similarities to a predicate device, not a data-driven AI/CAD study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. No "ground truth" establishment by experts for a test set is mentioned, as this is not an AI/CAD device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. No adjudication method for a test set 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

This information is not applicable and not provided. No MRMC study or AI assistance is mentioned. The NBI function is an optical filter, not an AI method.

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

This information is not applicable and not provided. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. No ground truth is established for this type of device submission.

8. The sample size for the training set

This information is not applicable and not provided. There is no training set for this device.

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

This information is not applicable and not provided. There is no training set mentioned.

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