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The MD VISION System is a video integration system that takes the original source image from one or more devices and sends it out to a variety of locations.

• It integrates images from as many as twelve individual video sources (e.g., VGA, DVI, Coaxial, S-video, etc.)
• It processes these video inputs (e.g., by size, position, location)
• It displays up to 12 images on a Flat Panel LCD display
• A touchscreen pad controls the LCD display
• It has no patient applied parts

Typical users are:

• The procedure suite clinicians who need information from several sources on screen instantly showing the visual information in the way they want to see it on a large LCD display that facilitates viewing.
• Users who want to show medical procedures in real time or record medical procedures for teaching.

The MD VISION System is a video integration system that takes the original source image from one or more devices and sends it out to a variety of locations.

• It integrates images from as many as twelve individual video sources (e.g., VGA, DVI, Coaxial, S-video, etc.)
• It processes these video inputs (e.g., by size, position, location)
• It displays up to 12 images on a Flat Panel LCD display
• A touchscreen pad controls the LCD display
• It has no patient applied parts

The MD VISION System is a video integration platform that integrates video outputs from various medical instruments onto an LCD display for healthcare professionals. The provided documentation primarily focuses on the device's substantial equivalence to predicate devices and adherence to electrical safety and EMC/EMI standards, rather than clinical performance metrics. Therefore, a table of clinical acceptance criteria and device performance based on a clinical study cannot be provided as the submitted text does not contain this information.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no clinical performance acceptance criteria or study results are explicitly provided in the document. The acceptance criteria described are related to electrical safety and electromagnetic compatibility (EMC/EMI) product standards.

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

Not applicable. The provided document describes conformance to electrical safety and EMC/EMI standards, which typically involve testing of the device itself rather than a "test set" of patient data.

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

Not applicable. Ground truth from experts is not relevant for the type of testing described (electrical safety and EMC/EMI).

4. Adjudication method for the test set:

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation, which is not the type of testing described here.

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:

No. The provided document concerns a video integration system, not an AI-powered diagnostic or interpretive device, and therefore no MRMC study was conducted or reported.

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

No. The MD VISION System is a hardware-based video integration system, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth from expert consensus, pathology, or outcomes data is not relevant for the type of electrical safety and EMC/EMI testing described. The "ground truth" for these tests is the defined requirements of the standards themselves.

8. The sample size for the training set:

Not applicable. The MD VISION System is not an AI/ML algorithm that requires a training set.

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

Not applicable. (See #8 above).

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the MD VISION System meets its acceptance criteria involves independent third-party testing for compliance with established international and national electrical safety and electromagnetic compatibility (EMC/EMI) standards.

• Testing Organizations:
  • NEMKO: A qualified third-party Electromagnetic Compatibility Test organization.
  • INTERTEK: A qualified third-party Medical Safety Electrical Testing Organization.
• Standards Evaluated:
  • EN60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests-Edition 2.1
  • EN60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
  • UL60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety harmonized to the USA National Electrical Code
  • CSA C22.2#601.1-M90 Issue: 1990/01/11 (R2005) Medical Electrical Equipment – Part 1: General Requirements for Safety-General Instruction No1: Update No 2 performed in conjunction with UL60601-1.
• Methodology: The device underwent testing by these organizations according to the specified standards, and reports were obtained "substantiating the device meets" these requirements. This typically involves a series of tests to verify electrical safety parameters and electromagnetic emissions and immunity.
• Conclusion: The results from these third-party tests demonstrate that the MD VISION System complies with the applicable performance standards (electrical safety and EMC/EMI). The document also states that "Appropriate listing markings to demonstrate compliance are applied to production devices."

The document establishes substantial equivalence by comparing the MD VISION System's technological characteristics and intended use to two predicate devices (K083321 and K073372), highlighting its ability to integrate multiple video sources and display them on large LCD screens, similar to the predicate devices.

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