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The Medi Pack is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures.

The KSEA Medi Pack is a compact video camera system consisting of a camera control unit, a cold light source, a documentation module, a 6.4-inch high performance LCD video monitor, a keyboard, and a camera head.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for test sets.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This document is a 510(k) summary for the KSEA Medipack, Model 20042020. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA clearance. It describes "Indications for Use" and "Device Description" but does not contain detailed information about specific performance acceptance criteria, clinical studies, or the methodologies used to establish ground truth or evaluate the device's accuracy in a way that would allow me to answer the questions posed. The document states that "minor differences between the Karl Storz Medi Pack and the predicate devices raise no new issues of safety and effectiveness," which is a common approach in 510(k) submissions, relying on the safety and effectiveness of the predicate device rather than presenting new detailed studies for the new device.

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