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The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.

The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone performance), or training set information for any device. The document is a 510(k) summary for a "Karl Storz Set for Endoscopic Assisted Intubation," outlining its description, indications, and substantial equivalence to predicate devices, but lacks the specific performance study data you are requesting.

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