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The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimensional eye movements and head movement (rotation and translation). It is a basic instrument for many types of vestibulo-oculomotor and visual research functions. The Eye Tracking Device will be used in combination with appropriate stimulus generators (rotating or translating devices, visual displays).

The provided text describes a 510(k) Summary for the Chronos Vision Eye Tracking Device (C-ETD). However, it contains very limited information regarding detailed acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text primarily focuses on the regulatory submission details, device description, and indications for use.

Based on the available information:

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

The document mentions "Testing was provided which verified system performance using an artificial eye model," but it does not specify any acceptance criteria or reported device performance metrics.

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

The document mentions "an artificial eye model" for testing, which implies a controlled, non-human, prospective study.

• Sample size for the test set: Not specified.
• Data provenance: "artificial eye model," so not applicable to human data country of origin or retrospective/prospective human study design.

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)

This information is not mentioned in the provided text. Since an "artificial eye model" was used, the concept of expert-established ground truth in the traditional sense might not apply, as the ground truth would likely be defined by the known parameters of the artificial model.

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

This information is not mentioned in the provided text.

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

This information is not mentioned in the provided text. The C-ETD is described as a device to measure eye movements, not one that directly assists human readers with diagnostic interpretation in a way that would typically be evaluated by an MRMC study comparing AI assistance.

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

The testing was done using an "artificial eye model" to verify system performance. This indicates a standalone performance evaluation of the device's measurement capabilities.

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

The ground truth for the test set was based on the known, controlled parameters of the artificial eye model.

8. The sample size for the training set

This information is not mentioned in the provided text. The document refers to "Testing...using an artificial eye model" for performance verification, but does not detail any machine learning component or training data.

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

This information is not mentioned in the provided text. (See point 8).

Summary of what is known from the text:

The C-ETD's performance was verified using an artificial eye model. No specific quantitative acceptance criteria, reported performance metrics (like accuracy, precision, etc.), or details about human expert involvement, sample sizes for training/testing with human data, or comparison studies are provided. The study appears to be a technical verification of the device's ability to measure eye movements from a controlled artificial source.

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