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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 "Non-prescription Sunglasses." This type of document is a regulatory approval, not a scientific study or a report detailing device performance and acceptance criteria.

Therefore, the input document does not contain any information related to:

• Acceptance criteria and reported device performance (in a table or otherwise)
• Sample size or data provenance for a test set
• Number/qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document simply states that the FDA has reviewed the 510(k) submission and determined the device (non-prescription sunglasses) is "substantially equivalent" to predicate devices, thus allowing it to be marketed. The "Indications For Use" section defines what the device is and its purpose, but not performance metrics or studies.

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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.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted. The document is an FDA 510(k) clearance letter for "Non-prescription Sunglasses," indicating that the device has been found substantially equivalent to a predicate device. It discusses regulatory matters such as marketing authorization, general controls, and compliance with regulations, but does not include any performance data or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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

This document is a 510(k) clearance letter for "Non-prescription Sunglasses". It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

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 document is a 510(k) clearance letter from the FDA for non-prescription sunglasses. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for medical device performance evaluation.

This letter primarily focuses on the device's classification and its substantial equivalence to pre-amendment devices, allowing it to be marketed. It does not delve into the technical performance details or the studies conducted to establish that performance.

Therefore, I cannot provide the requested information based only on the input text. The information requested (acceptance criteria, study details, expert involvement, etc.) would be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device