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The MIST Panoramic Laparoscope 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 Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.

The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.

This 510(k) summary for the MIST Panoramic Laparoscope does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a medical device (a rigid laparoscope) to the FDA, asserting its substantial equivalence to a previously marketed device (Comeg Endoscopes under K862275). It does not present de novo performance data from a new study with explicit acceptance criteria.

Here's why the requested information is not available in these documents:

• Substantial Equivalence (510(k)) Process: The 510(k) pathway is primarily about demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use. It typically doesn't require the same level of new clinical study data with specific performance metrics and acceptance criteria that a PMA (Premarket Approval) or a de novo classification might.
• Focus of the Document: This submission focuses on:
  • Identifying the device and its intended use.
  • Identifying a predicate device.
  • Stating that the subject device is "identical in intended use and materials" and has "no differences in the characteristics" compared to the predicate.
  • Providing basic information like cleaning and sterilization instructions.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed performance study based on the provided text. The document explicitly states: "There are no differences in the characteristics of the MIST Panoramic Laparoscope and the predicate devices. The MIST devices are identical to the predicate." This implies that the performance is presumed to be the same as the predicate device, and no new study was conducted to establish new performance criteria.

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