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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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The VISX WaveScan™ Wavefront System is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to -8.00 diopters spherical, and astigmatism from 0.00 to -6.00 diopters.

The WaveScan™ Wavefront System Model HS 1 autorefractor device is a diagnostic instrument designed to measure refractive error of the eye automatically by use of wavefront technology. Light travels in a procession of flat sheets known as wavefronts. As these wavefronts pass through an imperfect refractive medium including the cornea and the lens, the aberrations which are created by the irregular surfaces "wrinkle" the light rays and create wavefront errors or distortions. The instrument contains tiny sensors which measure the gradient, or slope, of the wavefront which emanate from the eye. After light travels through the eye's optical system and out again, the sensors accurately detect slight variations of wavefront irregularities as they exit the eye. The sensors then provide additional information within the confines of the instrument through a series of lenses and apertures which are subject to mathematical algorithms and software. Once analyzed by the computer, a refractive error read-out is provided to the user. This analysis is made from multiple points of light which precisely pinpoint variations in refractive status across the entrance pupil of the eye. This allows for the high level of accuracy of the instrument thus providing the user with very precise readings of refractive error.

Here's an analysis of the provided text, broken down by your requested categories:

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

The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, reproducibility, or other performance metrics. Instead, it describes a
comparison study against a predicate device (Canon R-50m) to demonstrate equivalence. The reported performance is relative to this predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The tests were conducted using a "model test eye developed by VISX, Inc. and modeled after the Gullstrand Standard Test Eye Model." Each test condition (combinations of myopic, hyperopic, and astigmatic errors) was repeated five times. The exact number of "test conditions" or specific refractive error combinations is not quantified, so a precise sample size for the test set in terms of individual measurements cannot be determined from the provided text.
• Data Provenance:
  • Origin: The model test eye was "developed by VISX, Inc."
  • Retrospective/Prospective: Neither. The testing was a bench study using a physical eye model, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for the test set was established by the design of the "model test eye" which was constructed to represent specific refractive errors. There were no human experts involved in establishing the ground truth for this bench testing.

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

Not applicable. There was no human adjudication as the testing was done against a physical model with known characteristics.

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. This document describes the performance of an automated diagnostic instrument (autorefractor) directly measuring refractive error. It is a standalone device, and no human-in-the-loop or MRMC study comparing human readers with and without AI assistance was performed or described.

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

Yes, a standalone performance evaluation was conducted. The WaveScan™ Wavefront System Model HS 1 is an "autorefractor device" designed to "automatically measure refractive error of the eye." The testing described is directly evaluating the device's ability to measure refractive errors on its own using a test eye model.

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

The ground truth used was known, precisely engineered refractive errors as embodied in the "Gullstrand Standard Test Eye Model" on which the VISX model eye was based.

8. The sample size for the training set

Not applicable. This device is an autorefractor, which uses optical principles and mathematical algorithms to determine refractive error. It is not described as a machine learning or AI device that requires a "training set" in the conventional sense. Its algorithms are based on established physics and optics.

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

Not applicable, as there is no mention of a training set for a machine learning algorithm.

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