(35 days)
The COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.
Sunglasses, Nonprescription, Class I 886.5850, 86HQY
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter for "Pathfinder Sunglasses." It states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) application.
A 510(k) clearance typically relies on demonstrating substantial equivalence, often through comparisons to predicate devices and adherence to relevant performance standards, rather than requiring extensive clinical trials with detailed acceptance criteria and performance reports like those detailed in your request.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on this document.
§ 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.