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To provide light for fiberoptic cables and provide a camera for procedure video capabilities. Provide light for instrumentation via fiberoptic cables For for use in. surgical fields or in office procedures. lightsource attaches to fiberoptic cable which is then attached to a video scope, the camera also attaches to the video scope (such as a video otoscope, or an intra oral dental scope).

Video Camera/Lightsource Combination Unit VCL-150

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a video camera/light source device (K980350 Video Camera/Lightsource Model VCL-150) and includes information about its substantial equivalence and indications for use. However, it does not detail:

• Acceptance criteria and reported device performance (in a table format).
• Sample size or data provenance for any test set.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether a multi-reader, multi-case (MRMC) study was done or its effect size.
• Whether a standalone algorithm-only performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.

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