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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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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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