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The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic. As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections.

The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized "Impact Resistant Lenses" made from glass or plastic.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Sunglasses" (K971551), indicating that the device is substantially equivalent to a predicate device.

The letter explicitly mentions:

• Trade Name: Sunglasses
• Regulatory Class: I
• Product Code: 86 HQY
• Indication For Use: "The sunglasses we produce consist of metal or plastic frames with absorbing, reflective, tinted or photosensitized 'Impact Resistant Lenses' made from glass or plastic. As a medical device, its main use is to protect the eyes from bright sunlight. It is available in touring, sport and other model types but should not be used in situations requiring industrial safety lenses. It also can't provide refractive corrections."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about specific studies, like sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The FDA 510(k) clearance process for Class I devices like sunglasses often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trial data with specific performance metrics as might be seen for higher-risk devices or software as a medical device (SaMD). The criteria are typically related to material safety, optical properties (e.g., UV protection, impact resistance), and labeling.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study data based on the provided text.

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