(35 days)
RUFF Work Eyegear sunglasses are intended for use by tradesmen and the general population. They are designed to protect the wearer's vision from the potentially harmful effects of sunlight (glare) and ultraviolet light.
RUFF Work Eyegear Sunglasses
The provided text is a 510(k) clearance letter from the FDA for "RUFF Work Eyewear" (later clarified as "RUFF Work Eyegear Sunglasses"). This document indicates that the device has been cleared for marketing based on substantial equivalence to a predicate device.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter's content focuses on:
- Confirming the review of the 510(k) notification.
- Stating that the device is substantially equivalent to legally marketed predicate devices.
- Clarifying the regulatory class and product code.
- Explaining the implications of substantial equivalence and general controls provisions of the Act.
- Providing contact information for further inquiries about regulations.
The "Indications For Use" section on the last page describes the intended purpose of the device: "RUFF Work Eyegear sunglasses are intended for use by tradesmen and the general population. They are designed to protect the wearer's vision from the potentially harmful effects of sunlight (glare) and ultraviolet light."
Therefore, based solely on the provided text, I cannot answer the questions related to acceptance criteria and study details. The document is a regulatory clearance, not a technical study report.
§ 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.