(151 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.