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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.

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