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The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.

The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers.

This K970608 submission describes a medical device, the EVT® Marker Board, as an accessory to an image-intensified fluoroscopy x-ray system. The submission is a "Summary of Safety and Effectiveness," which is part of the 510(k) premarket notification process for Class II medical devices seeking substantial equivalence to a predicate device.

Based on the provided text, the device is the EVT® Marker Board, which is an all-mechanical aid external to the body (not an AI/software device). Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and multi-reader studies are not applicable to this submission.

Here's the breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a mechanical device for marking anatomical landmarks during fluoroscopic procedures. The "acceptance criteria" for such a device in a 510(k) submission generally revolve around substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The document states it is substantially equivalent, but does not provide specific performance metrics beyond its design and function.

2. Sample size used for the test set and the data provenance

Not applicable. There is no "test set" in the context of an algorithm or diagnostic performance study for this device. The evaluation for substantial equivalence would involve comparing its features and safety profiles to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no ground truth establishment in the context of an algorithm's diagnostic performance for this mechanical device.

4. Adjudication method

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a mechanical marking device, not an AI or diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used

Not applicable.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device and Evidence as per the provided text:

• Device Name: EVT® Marker Board
• Intended Use: Used to identify anatomical landmarks during fluoroscopic procedures.
• Device Description: An all-mechanical aid placed external to the body, consisting of a polycarbonate plate housing radiopaque, movable markers and a control box to remotely move the markers.
• Predicate Device: IZI Medical Products Topographic Marker (K930752).
• Basis for Substantial Equivalence: The EVT® Marker Board is stated to be substantially equivalent to the predicate device. The key difference highlighted is the mechanism of use:
  • EVT® Marker Board: External to the body, remote movement of markers.
  • Predicate Device: Adhesive markers positioned directly on the body.

The fundamental proof of meeting "acceptance criteria" for a 510(k) submission like this is establishing substantial equivalence to a legally marketed predicate device. The document states this has been done, implying that the EVT® Marker Board has been deemed as safe and effective as the IZI Medical Products Topographic Marker for its intended use, despite the difference in mechanism.

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