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Intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

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This document is a letter from the FDA regarding a 510(k) premarket notification for "Sunglasses." It primarily addresses the regulatory status and substantial equivalence of the device, rather than providing a study on performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered:

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

• Cannot be extracted. The document is a regulatory approval letter, not a device performance study report. It does not list any specific acceptance criteria or performance metrics for the sunglasses.

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

• Cannot be extracted. No test set or data provenance is mentioned as this is not a study report.

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)

• Cannot be extracted. No ground truth establishment or expert involvement for a test set is discussed.

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

• Cannot be extracted. No adjudication method is mentioned.

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

• Cannot be extracted. This document predates widespread AI development for medical devices and does not describe any MRMC studies or AI involvement. The device is "Sunglasses," not an AI-powered diagnostic tool.

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

• Cannot be extracted. No algorithm or standalone performance is discussed.

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

• Cannot be extracted. No ground truth for performance evaluation is mentioned. The "ground truth" implied by the 510(k) process is the existence of legally marketed predicate devices that the new device is substantially equivalent to.

8. The sample size for the training set

• Cannot be extracted. No training set is mentioned.

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

• Cannot be extracted. No training set or its ground truth establishment is discussed.

Summary:

This document is solely an FDA 510(k) clearance letter confirming that "Sunglasses" manufactured by Elegance Optical Mfy. Ltd. are substantially equivalent to pre-amendments devices. It does not contain any information regarding performance studies, acceptance criteria, test sets, or ground truth establishment.

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