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The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.

The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator and a charger unit. The charger unit serves both as a continuous charger as well as a convenient base for the instrument. The slit illumination is focused onto the corneal surface, which is observed through the operating microscope (or the surgeon may also alter the angle of the slit illumination). The length and width of the slit may be altered by the surgeon. The slit illuminator allows the control of slit width to enhance observation of structural detail. The slit illuminator allows control of slit width from 0 to 10.0 mm via means of sliding control knobs.

The provided text describes a 510(k) premarket notification for the VISX CV SI-1 CustomVue™ Slit Illuminator. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or AI-powered device.

Therefore, many of the requested categories (such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from the given text.

The text primarily outlines the device's intended use, its description, and non-clinical testing for compliance with electrical and electromagnetic compatibility standards. It concludes that based on these non-clinical tests, the device supports its proposed indication for use and presents no new safety concerns compared to the predicate device.

Here's a breakdown of the information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Inferred from Non-Clinical Testing):
  • Compliance with IEC 60601-1 (general requirements for medical electrical equipment).
  • Compliance with IEC 60601-1-2 (electromagnetic compatibility requirements for medical electrical equipment).
  • Demonstration of no new safety characteristics compared to the predicate device.
  • Full support of the proposed indication for use (inspection of the anterior segment of the eye).
• Reported Device Performance: The document states that the testing demonstrated the device "fully supports the proposed indication for use, and that no new safety has demonstrated that it fully Supports the proposed tharacteristics of this new device." It also passed the specified IEC standards.

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

• Not applicable/Not provided. The text refers to "non-clinical testing results," which typically involve testing the physical device against engineering and safety standards, not a "test set" of patient data.

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

• Not applicable/Not provided. Ground truth establishment with experts is not relevant for this type of non-clinical device testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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 MRMC study was done. This device is a Slit Illuminator, a diagnostic illumination tool, not an AI-powered diagnostic algorithm.

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

• Not applicable. This is not an algorithm, but a physical illumination device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. "Ground truth" in the context of diagnostic performance studies is not relevant here. The "ground truth" for this device's performance would be its ability to physically illuminate the eye as intended and meet safety standards.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a training set.

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

• Not applicable.

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