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Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

The provided text is a 510(k) clearance letter from the FDA for "Sunglasses." This document is a regulatory approval for a medical device and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the letter states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the device was found to be similar enough to existing, legally marketed devices that it did not require extensive new testing to prove safety and effectiveness.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Results of a multi-reader, multi-case comparative effectiveness study.
• Results of a standalone (algorithm-only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

These elements are typically found in a clinical study report or a premarket approval (PMA) application, not in a 510(k) clearance letter for a Class I device like sunglasses, which often relies on established performance standards or comparison to predicates.

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