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The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification.

The KSEA Contact Micro-Laryngoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.

This document is a 510(k) summary for a medical device called the Karl Storz Contact Micro-Laryngoscopes. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table or any of the detailed information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The provided text only includes:

• Device Identification: Karl Storz Contact Micro-Laryngoscope
• Indication: "The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification."
• Device Description: "a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel."
• Substantial Equivalence Claim: "The KSEA Contact Micro-Laryngoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Contact Micro-Laryngoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."

To answer your request, a document detailing performance testing, clinical studies, or engineering bench tests with defined acceptance criteria would be needed. This 510(k) summary focuses on the administrative aspects of regulatory submission rather than detailed performance data.

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