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The MIST Micro Interchangeable Scope System ™ is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.

The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.

The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided.

The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.

The provided text is a 510(k) summary for a medical device (MIST Micro Interchangeable Scope System) and does not describe a study involving acceptance criteria, device performance metrics, or AI. Instead, it describes a substantial equivalence determination for a physical medical device. Therefore, I cannot extract the requested information as it is not present in the given text.

Here's why and what the document does discuss:

• 510(k) Summary: This document's primary purpose is to demonstrate "substantial equivalence" of a new medical device to a legally marketed predicate device. This is a regulatory pathway in the US.
• Substantial Equivalence: MIST claims its device is substantially equivalent to the Galileo Endoscope (K962116) in intended use and materials, noting the primary difference is that the MIST system is a two-piece device.
• Device Description: The MIST Micro Interchangeable Scope System is a two-piece, rigid, fiberoptic laparoscope with an interchangeable universal eyepiece and various shaft sizes, used for illumination and direct visualization during diagnostic and general surgical procedures.

In summary, the provided text does not contain any of the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information about experts establishing ground truth or adjudication methods.
• Any mention of AI, MRMC studies, or standalone algorithm performance.
• Specific ground truth types (e.g., pathology, outcomes data).

The document is purely a regulatory submission for a physical medical device, not a performance study of a device, especially not one involving AI or detailed clinical trial results.

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