(4 days)
Both devices are intended for the same use, that of providing visible light for the illumination of surgical headlights and various rigid or flexible endoscopes that contain fiber bundles for illumination. Applications for both systems include, but are not limited to, externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhino-laryngoscopy, urology, and vascular endoscopy.
Both devices consist of a light source control box which houses a Xenon lamp, power supply, and connects to a proprietary fiberoptic cable. With a fiber bundle adapter, this illuminator can also be used with regular fiber bundle optic cables and headlamps.
It appears the provided text describes a 510(k) Premarket Notification for a medical device called the "Cogent Light XLS Illuminator System." However, the text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI-powered diagnostic device.
The document focuses on:
- Safety: Discusses safety interlocks, cooling mechanisms, thermal protection, and measures to mitigate risks associated with lamp failure (e.g., specific power range, limited operating hours, baffles for sound/debris). These are safety design features, not performance metrics.
- Effectiveness: Describes the light spectral quality, the benefits of its single fiberoptic cable compared to traditional fiber bundles in terms of uniform illumination, and its equivalence to a predicate device. This section talks about the type of light produced and the method of delivery, which implicitly relates to effectiveness in illuminating surgical fields, but it doesn't quantify performance against specific criteria like sensitivity, specificity, accuracy, or human reader improvement, as would be expected for a diagnostic AI.
- Summary: States the device's intended use and design, emphasizing its substantial equivalence to a predicate device for providing visible light for illumination in various endoscopic procedures.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies because this information is not present in the provided 510(k) summary for the Cogent Light XLS Illuminator System. The device described is an illuminator, a tool for providing light during surgery, not a diagnostic or AI-powered system that would typically undergo such performance evaluations for regulatory submission.
§ 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.