(64 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 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:
- The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
- 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)
| Specification (Acceptance Criteria implicitly tied to predicate) | Subject Device Performance (EVIS EXERA II 180 System Components) | Predicate Device Performance | Conclusion on Equivalence |
|---|---|---|---|
| CLV-180 (Light Source) | |||
| Power Supply | 100-120V~±10%, 50/60 Hz±1Hz | 100-240V~±10%, 50/60Hz±1Hz | Similar |
| Size | 383(W)×162(H)×536(D)mm | 381(W) × 162(H) × 536(D)mm | Slightly changed |
| NBI Filter | Provided | Provided (Implicit in CLV-160A's K051645) | Same (Function added) |
| CV-180 (Video System Center) | |||
| Size | 382(W)×91(H)×490 (D)mm | 370(W)×91(H)×462 (D)mm | Slightly changed |
| Weight | 10 kg | 10.6 kg | Slightly changed |
| NBI Observation | NBI function | NBI function (Implicit in CV-160A's K051645) | Same (Function allows NBI processing) |
| CYF-V2/VA2 (Cysto-Nephro Videoscope) | |||
| Field of View | 120° | 120° | Same |
| Depth of Field | 3-50 mm | 3-50 mm | Same |
| Outer Diameter of Distal End | φ 4.8 mm bullet-shaped | φ 5.4 mm | Changed (Smaller) |
| Inner Diameter of Instrument Channel | φ 2.2 mm | φ 2.2 mm | Same |
| XCYF-VQ (Cysto-Nephro Videoscope) | |||
| Depth of Field | 3-20 mm | 3-50 mm | Changed |
| Outer Diameter of Distal End | ⌀ 5.9 mm | ⌀ 5.4 mm | Changed (Larger) |
| Inner Diameter of Instrument Channel | ⌀ 2.0 mm | ⌀ 2.2 mm | Changed (Smaller) |
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.
§ 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.