(262 days)
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R : These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.
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.
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.
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system with the compatible cystscopes is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.
The primary components of the subject system are:
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, CYF TYPE V2R (CYF-V2, CYF-VA2, CYF-V2R)
EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
The provided document is a 510(k) premarket notification for the "EVIS EXERA II 180 SYSTEM". This document is a regulatory filing for a medical device and describes its intended use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence. It does not contain information about the performance or study results of a device in the context of acceptance criteria as would be found in a clinical study report or a robust performance evaluation for an AI/ML device.
The relevant sections are:
- Section 7. Summary of Non-clinical Testing: States that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
- Section 8. Conclusion: States that the device is "substantially equivalent" to predicate devices and does not change fundamental scientific technology or intended use.
Based on the provided text, I cannot provide the specific details requested regarding acceptance criteria and a study proving the device meets them in the manner of an AI/ML device performance evaluation because:
- The document is a 510(k) submission, not a performance study report. It aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove specific numerical performance metrics against defined acceptance criteria using a test set with ground truth.
- The device appears to be a traditional endoscopic imaging system, not an AI/ML-powered device. The questions regarding AI/ML-specific details (like human reader improvement with AI assistance, standalone algorithm performance, training set size, etc.) are therefore not applicable to this document.
- The "acceptance criteria" mentioned are related to design verification tests and risk analysis based on ISO 14971:2007, which pertains to quality management systems and risk management for medical devices, not clinical performance metrics for diagnosis or treatment. The document does not list specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) as acceptance criteria for functionality or effectiveness in the way an AI/ML device would.
Therefore, I must state that the requested information cannot be extracted from the provided text. The document describes a regulatory pathway for a conventional medical device (an endoscope system) and refers to manufacturing and risk management standards rather than specific diagnostic performance studies with acceptance criteria and test set details.
§ 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.