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Olympus Light Guide Cable A3908 is intended for use in conjunction with Olympus OTV-SSC Video System and accessories with optical endoscopes for observation and recording during diagnostic and therapeutic applications requiring Type CF equipment.

Olympus OTV-S5C Video System, its associated accessories and ancillary equipment for CF application.

This documentdoes not contain information related to acceptance criteria or a study proving device performance for the Olympus OTV-S5C Video System or the A3908 Light Guide Cable.

The provided text is a 510(k) summary and an FDA clearance letter for a medical device. These documents primarily focus on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study.
• Intended Use and Indications: Defining how the device is meant to be used.
• Regulatory Classification: Placing the device within the FDA's regulatory framework.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth.

This information would typically be found in detailed pre-clinical or clinical study reports, which are usually referenced or summarized within a 510(k) submission but not fully contained in the public summary.

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