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The indication for use of the Xenon Light Source PES 1 is to provide illumination for fiberoptic endoscopy to gastroenterological, urological, gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces current equipment in this branch. Operation is only allowed in medically used rooms in which the electrical installation meets the safety requirements of national standards (e.g. VDE 0107). The device is not intended for direct application at the heard or central nerve system.

Xenon Light Source PES 1

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a Xenon Light Source PES-1, dated September 14, 1999. It states that the device is substantially equivalent to a predicate device and outlines regulatory information and responsibilities.

However, it does not include details about:

• Acceptance criteria table and reported device performance
• Sample sizes, data provenance for a test set
• Number of experts or their qualifications for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (pathology, outcomes, etc.)
• Training set sample size
• How ground truth for the training set was established

This document is solely a regulatory clearance and not a performance study report.

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