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The LSI Endoscopic External Accessory Channel and Accessories Product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access during endoscopic procedures.

The LSI Endoscopic External Accessory Channel and Accessories Product is a sterile conduit that can be safely attached to common endoscopes. This Endoscopic External Accessory Channel enables the passage of additional endoscopic instruments to enhance the effectiveness of diagnostic and therapeutic interventions.

The provided text describes a 510(k) premarket notification for a medical device, the "LSI Endoscopic External Accessory Channel and Accessories Product." This document is a regulatory submission for market clearance, not a study report detailing acceptance criteria and performance. Therefore, the information required to populate the fields for acceptance criteria and a study proving device performance is not available in the provided text.

Specifically, the document focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence to a predicate device.
• Device description: A brief explanation of the device's function.
• Intended Use/Indications For Use: How the device is meant to be used.

There is no mention of a clinical study, performance metrics, acceptance criteria, or any of the detailed study parameters requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC studies, standalone performance).

Therefore, I cannot provide the requested table and study details based on the information given.

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