(25 days)
INTENDED TO BE WORN BY CHILDREN TO PROTECT THE EYES FROM SUNLIGHT.
Not Found
The provided FDA document is a 510(k) clearance letter for "Sunglasses" (K972014), issued in 1997. This type of document confirms that a device is substantially equivalent to a legally marketed predicate device, meaning it's generally safe and effective for its intended use.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Here's why this information is absent:
- Device Type: Sunglasses, especially those intended for children, are generally considered low-risk devices. For such devices, the FDA typically relies on substantial equivalence to predicate devices rather than requiring extensive clinical trials or performance studies with detailed statistical metrics as would be expected for high-risk medical devices or AI/ML-driven diagnostics.
- 510(k) Process: The 510(k) pathway primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. While some performance data might be submitted, it's often related to basic safety standards (e.g., UV protection levels, material safety) and not the kind of detailed clinical performance data (sensitivity, specificity, AUC) typically found in submissions for AI-based medical devices or more complex diagnostics.
- Date of Document: The document is from 1997, predating the widespread use and regulation of AI/ML in medical devices. The methodologies for evaluating AI performance (e.g., test set sizes, ground truth establishment with multiple experts, MRMC studies) were not relevant to the review of sunglasses at that time.
Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document confirms market clearance for a device based on substantial equivalence, but it does not detail the specific performance metrics or studies you've inquired about, which are more pertinent to advanced medical technologies, particularly those involving AI.
§ 886.5850 Sunglasses (nonprescription).
(a)
Identification. 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.