Search Results

The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Not Found

This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

Ask a specific question about this device