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The Model LS 6035/LS 6180 Xenon Light Source is intended for use in endoscopic applications.

The Xenon Light Source Model LS6035 is designed to supply light for endoscopic diagnostic observation and surgical procedures.

The Models LS 6035/LS 6180 is an electronic light source using a 300/180Watt Xenon lamp, to provide light for endoscopic procedures.

This document is a 510(k) summary for a medical device, specifically a Xenon Light Source, and not a study describing acceptance criteria and device performance. Therefore, it does not contain the information requested in the prompt.

The document primarily focuses on establishing "substantial equivalence" of the Xenon Light Source Models LS 6035/LS 6180 to already legally marketed devices. This is a regulatory pathway to market medical devices in the United States, indicating that the new device is as safe and effective as a predicate device.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: This document states that the new models "meet the same specifications" as the equivalent devices, but it does not list those specifications (acceptance criteria) or present any test results showing how the new devices performed against them.
• Study Details: There is no mention of a study to prove the device meets acceptance criteria. The 510(k) process for this type of device often relies on demonstrating similarity to existing devices rather than extensive new clinical trials or performance studies that generate quantified performance metrics.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set, and Ground Truth for Training Set: None of these details are present because the document is not an efficacy or performance study report. It's a regulatory submission to demonstrate equivalence.

In summary, the provided text is a 510(k) summary for a Xenon Light Source, which is a regulatory document, not a scientific study report describing device performance against specific acceptance criteria.

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