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The KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.

The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.

The provided text describes a 510(k) summary for the Karl Storz Xenon-100 SCB Light Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is a regulatory pathway in the US that avoids the need for extensive clinical trials by showing a new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a clinical performance study with AI (like multi-reader multi-case studies, standalone performance, ground truth, sample sizes, etc.) is not present in the provided document.

Here's why and what information is available:

• No acceptance criteria or study results for device performance are listed. The document states: "The minor differences between the Karl Storz Xenon-100 SCB Light Source and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This implies that extensive comparative performance testing (as would be done for a novel AI device) was not required for this 510(k) submission.
• The focus is on "Substantial Equivalence." The entire submission hinges on demonstrating that the new device is functionally similar to an already approved device.
• The device is a "Light Source unit," not an AI-powered diagnostic or therapeutic device. The nature of the device (a light source for endoscopes) does not typically require the types of performance studies involving human readers, ground truth establishment, or AI algorithms as outlined in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, deep learning studies, multi-reader multi-case studies, and ground truth in the way you've requested, as this information is not part of this 510(k) submission document.

However, based on the document, I can provide the following relevant details about the submission process:

• Device Name: Xenon-100 SCB Light Source
• Intended Use: For use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons. It features remote control, central operation, central display, automatic initial setting, and interlocking operation to the Karl Storz SCB Control Computer.
• Regulatory Pathway: 510(k) Premarket Notification, demonstrating Substantial Equivalence to a predicate device.
• Predicate Device: A legally marketed device with similar basic features and intended uses, but not explicitly named in the provided text.
• Date Submitted: September 30, 2008
• Date Received by FDA: October 1, 2008
• FDA Clearance Date: December 18, 2008

To reiterate, the provided document does not contain the specific information you've asked for regarding acceptance criteria, study design, datasets, or AI performance because it's a 510(k) for a light source, not an AI-enabled device requiring such validation studies.

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