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This device is designed to supply light for endoscopic diagnostic and surgical procedures.

This light source is a 300W xenon light source with manually or automatically controlled brightness. This device is not for use with flash photography.

The provided text is a 510(k) summary for a medical device: the Karl Storz Xenon 300 Light Source for Non-Flash Applications. This document is a regulatory submission for premarket notification and does not contain information related to software performance, clinical studies, or AI/ML-driven device evaluation.

Therefore, I cannot extract any information regarding:

1. Acceptance criteria and reported device performance: This device is a light source, not a diagnostic or AI-driven tool for which performance metrics like sensitivity, specificity, or F1-score would be applicable.
2. Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, or how ground truth was established. These are all concepts relevant to the evaluation of AI/ML algorithms or diagnostic tools, which are not present in this document.

The document discusses "substantial equivalence" to a predicate device, meaning its safety and effectiveness are established by demonstrating similarity to an already legally marketed device. It does not involve a study proving performance against acceptance criteria in the way a diagnostic or AI device would.

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