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The Galileo Disposable Endoscopes are endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Disposable Endoscopes indications for use include choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.

The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology. The Galileo Disposable Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user.

This 510(k) summary for the Galileo Disposable Endoscopes does not contain the specific details about acceptance criteria, a study proving performance against those criteria, or the methodology for such a study.

The document focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. It describes the device, its intended use, and compares its technological characteristics to existing devices.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are typically found in detailed performance studies, which are not included in this 510(k) summary.

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